Pharmaceutical & Cosmetic Review November/December 2021

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NOV/DEC 2021 Volume 48 | Number 11

48

years www.pharmacos.co.za

New concepts to bring your fragrance creations to life The relationship between QC and QA in cosmetics manufacturing Production solutions that enable short-run printing in the pharma industry

THE JAR PEOPLE

An inside look at Teqal’s new R150m packaging factory


Your look Our expertise Your beauty Our inspiration Reflections of perfection

Tel: 011-494-6700 Email: nataliem@cjpchemicals.co.za Web: www.cjpchemicals.co.za


CJP CHEMICALS

A best-in-class supplier meeting the needs of every FMCG category CJP Chemicals provides chemical solutions, technical competence and supply chain partnerships across many industries. Over the last three years, the company has distributed in excess of 200 000t of raw materials and ingredients to customers nationwide.

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n 2016, the Bud Group welcomed CJP Chemicals into its extensive portfolio of companies. Bud, as its name suggests, is built to grow through a diversified group of scale and relevance, driven by innovation and agility. It is an enabling platform that creates a permanent home in which its businesses can grow and develop, ultimately creating long-term value across the following four platforms: 1. chemicals and minerals 2. industrial services 3. building material 4. financial services. CJP Chemicals finds its home within the chemicals and minerals platform.

CJP CHEMICALS, A BUD COMPANY CJP Chemicals has a proud history in Southern Africa and is committed to providing excellence and innovation to its customers and principals. It is a company that strives to extract best practices from its people and operations in order to exceed expectations. This also builds trust among its customers and principals. Through continuous innovation and everyday excellence, CJP Chemicals aims to be an organisation of choice for its customers, principals and staff. Its four key pillars of growth, innovation, performance and environment are continually driven by excellence, thereby fostering mutual and sustainable growth for its customers, principals, staff and shareholders. CJP Chemicals has four branches nationwide, located in Cape Town, Durban, Gqeberha (Port Elizabeth) and Johannesburg, which is the head office. The company employs 40 experienced

“CJ P Chemicals aims to be an organisation of choice for its customers, principals and staff” customer-facing personnel, who cover the relevant industries it services on a nationwide basis. A further 200 people are employed nationally in various roles and it boasts a daily delivery capacity of 450t, which is managed by its in-house fleet. CJP Chemicals is also known for its distribution compliance and state-of-theart warehouse, which can accommodate stock packs from as little as 1kg to bulk storage requirements.

The clusters that operate within CJP Chemicals include food and nutrition, pharma and personal care, lubes and energy, industrial, and wine and exports. From innovation to commercialisation and actives to excipients, the product portfolio of its personal care and pharmaceutical cluster includes an extensive range of raw materials and ingredients. These products deliver easeof-use technical performance and efficacy


PHARMA AND PERSONAL CARE PRODUCT PORTFOLIO CJP Chemicals’ extensive product range includes anti-ageing, anti-bacterial, anticaking, anti-fungal, bulking, conditioning, moisturising, exfoliating and matting agents. It also supplies butters, carbomers, carrier oils, carrageenans, agents, emollients, natural and synthetic emulsifiers, essential oils, excipients, fatty acids, fatty alcohols, fillers, fragrances, glycerine, gelling agents, glycols, humectants, lactose, lecithins and lanolin derivatives. Maltitol, maltodextrin and peeling granules are included in the portfolio, as well as polysaccharides, polysorbates, polymeric colourants, preservatives, quat compounds, sebum-regulating and brightening ingredients, styling polymers, sorbitol starches, silicones and skin care actives. CJP Chemicals’ PPC team: Landi Jouber and Nicole du Toit (front row), Nthabaleng Tsotetsi, Lucky Moletsane and Priya Padayachee (second row), Monica Ramogare and Shireen Fourie (third row), Lauren Dorgan and Liza Viviers (fourth row), Donovan Clulee, Natalie MacGregor and Madelein Swart (fifth row), and Judy Nobin, Jakes Gopalan and Bianca Letcher (missing from the photo)

The company also distributes ingredients for sports nutrition, as well as soap noodles, fatty esters, soaps, solubilisers, UV filters, surfactants, thio-compounds, vegetable oils, waxes and white mineral oils.

to its customers’ formulations. Customers are fully supported in terms of regulatory requirements to ensure they comply with industry standards. Thanks to its dedicated technical laboratory services, CJP Chemicals is also equipped to provide customers with customised solutions. The personal care offering is fully supported by a technical innovation centre based in Johannesburg which hosts customer and supplier workshops, offers assistance in terms of problem-solving and technical support, and provides training. The centre also excels in prototype and formulation development in line with market trends and offers tailormade solutions and assistance, enabling its customers to innovate.


CJP CHEMICALS

WELLNESS BY WINDROSE

“The personal care offering is fully supported by a technical innovation centre based in Johannesburgs”

As part of the CJP personal care and pharma cluster, Wellness by Windrose is a first of its kind for the company as it is a retail brand. Windrose Oils was originally established in Johannesburg as a family-owned business. A few years ago, CJP Chemicals acquired the Windrose business and has since transformed it into a trusted wellness brand sold in retail. In 2020, Windrose evolved and Wellness by Windrose was created. The brand has shifted in line with current market trends, with its core focus being on wellness and self-care.

The Wellness by Windrose team is committed to service excellence and developing modern innovations in the fields of wellness and naturality. It offers turnkey, value-added solutions and promises to provide customers with responsibly-sourced, safe and quality manufactured products. The following product ranges are included in the Wellness by Windrose portfolio:

Wellness by Windrose endeavours to partner with responsible suppliers who are committed to sustainability, ethical sourcing and supporting rural communities. The goal is to develop products inspired by nature and to make these products accessible to all.

• Essential oils – bergamot, camphor, chamomile, roman, citronella, eucalyptus, frankincense, geranium, grapefruit, juniper berry, lavender, lemon, lemongrass, marjoram, Melissa, neroli, orange, patchouli, peppermint, petitgrain,

Wellness and self-care are a core focus of Wellness by Windrose

rose blend, rose geranium, rosemary, sandalwood blend, spearmint, thyme, tea tree, and ylang-ylang. • Carrier oils – sweet almond, apricot kernel, argan, avocado, evening primrose, grapeseed, jojoba, golden rosehip, and wheatgerm c. • Blends – anti-stress, arnica rub, muscle rub, tissue oil, and olive butter. With its robust infrastructure, talented teams and customer-centric approach, CJP Chemicals is on target to achieving measurable growth in the years to come.•

CJP Chemicals – www.cjpchemicals.co.za


NOV/DEC 2021

Contents

Volume 48 | Number 11 www.pharmacos.co.za

37 Pharma Focus Acquisition sees Marchesini expand into new technologies Romaco speeds up delivery times using standardisation Lipex extruder enables rapid liposomal drug manufacturing

30

Short-run printing solutions for the pharma industry Sustainable paper alternative for blister packaging

40

34 9 News AlcoNCP inaugurates Africa’s biggest fermentation distillery

18 Ingredient & Formulation Innovation

28 QA, QC, Compliance & Training

Chanel collaborates with Sulapac on sustainable cap

Concepts from Merck to amplify self-care in 2022

How to strive for continual improvement in pharma GMP

Vantage increases production capacity for mild surfactants

Evonik’s ceramides for all tones and textures

The relationship between QA and QC in cosmetics manufacturing

14 Industry Talk IPASA study highlights innovative pharma MNCs as frontrunners in Africa Omron cobots case study: lending a hand at the end of the line

Silicone replacements based on hydrogenation technology SugaBoost surfactants from Colonial Chemical

32 Fragrances & Essential Oils

Overcome effervescent manufacturing issues with galenIQ 721

Givaudan launches olfactive social listening tool, DigiPulse

AECI’s cost-effective additive to increase product performance Parsol EHT advances innovation eco-friendly sun care products

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NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

SAEOPA contributes to first local essential oils standard Insights from o6 Agencies to bring fragrance creations to life Symrise expands sustainable patchouli programme

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On the cover

An inside look at Teqal’s new R150m packaging factory

“Now fondly known as ‘the jar people’, Teqal’s expanded factory can produce up to 40m jars per annum”


SPONSORED CONTENT

Sustaining hand hygiene Handwashing has come under the spotlight during the COVID-19 pandemic. 94% of consumers surveyed by Kimberly-Clark Professional™ say they are washing or sanitising their hands more than they did before the pandemic.1 Practicing hand hygiene is a simple yet effective way to help prevent the spread of germs, particularly after using the toilet or handling waste and before preparing food. Now that the rate of handwashing has increased, this needs to be sustained and supported.

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hile practicing excellent hand hygiene is the responsibility of every individual, it is up to facility managers to provide the means to do so. The World Health Organization released new recommendations and guidelines stipulating that hygiene facilities should be established at the entrance to all public and private commercial buildings. Without the correct hand hygiene system in place, helping to stop the spread of bacteria and germs with clean hands will always be a challenge. Just as buildings and facilities are equipped for specific functions, hand hygiene systems can vary in utility and performance. Selecting the right system requires various considerations, such as the hygiene needs of the facility, budget, operational efficiency, product compatibility and brand familiarity. Investing in desirable and convenient hygiene infrastructure and products is likely to sustain the increased hand hygiene practices. It is also a visible indicator of the level of investment companies are making in their building and in their people. 84% of consumers view familiar brands as an important signal of a clean and hygienic environment. 2

the spread of germs consider installing dispensers with no joins, ridges, keyholes or other dirt traps. Moisturising foam hand soap serves as a complementary skin care product for high-capacity, electronic dispensers. Foam soap delivers up to twice as many washes per litre as conventional liquid soap and controlled dispensing reduces waste. Foam soap is ideal when water is limited, as it requires 16% to 45% less water to wash hands and it rinses faster. When water is not available, hand sanitiser offers a convenient hand hygiene solution. Hand sanitiser should contain at least 60% alcohol to help prevent people within your facility from spreading germs to others.

HAND DRYING IS VITAL Since nearly 95% of adults do not wash long enough to thoroughly clean the bacteria and germs from their hands 3, hand

"While businesses are responsible for keeping employees and visitors safe, we’re here to help them INNOVATIVE DISPENSING SOLUTIONS create a hygiene If you haven’t already, consider installing improvement plan" the latest electronic or touchless dispensing solutions. To further reduce

Did you know? You can schedule a virtual hygiene site walk with a Kimberly-Clark Hygiene Professional. If you would like some assistance in ensuring a hygienic environment, visit https://home. kcprofessional.com/sa/hygiene-resources and let Kimberly-Clark guide you to achieve the level of hygiene your facility needs.

drying is important too. Drying hands with a single-use paper towel is the safest way to reduce the spread of viruses, because the rubbing process of paper towels physically removes bacteria along with moisture. Paper towels are the recommended hand drying method of the World Health Organization. “While businesses are responsible for keeping employees and visitors safe, we’re here to help them create a hygiene improvement plan,” says Kristel Dreyer, Associate Marketing Manager of Kimberly-Clark Professional™ South Africa. “We have a lot of great resources to help companies implement more hygienic hand cleaning and drying protocols.” •

REFERENCES: 1. Kimberly-Clark Professional, Hygiene Behaviour Consumer Study, May 2020 2. Kimberly-Clark Professional COVID-19 Thought Leader Content Research – Consumer Topline (June, 2020) 3. Borchgrevink, C.P., Cha, J. and Kim, S., 2013. Hand washing practices in a college town environment. Journal of environmental health, 75(8), p.18.; Hand Washing Practices in a College Town Environment, Journal of Environmental Health

Kimberly-Clark Professional™ – www.kcprofessional.co.za

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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FROM THE EDITOR

The team EDITORIAL

Cheers to the challenges of 2021!

T

he pace at which this year has progressed has been nothing short of surprising. It feels as if 2021 simply wants to be over and done with, especially since South Africa has had a great deal to cope with this year. The pandemic, load shedding and civil unrest are among the most significant events we’ve had to navigate and by now, most of us are experiencing total COVID fatigue. This is our last edition for the year, and I’m pleased to bring you some easy reading and enjoyable content that is sure to soothe your tired mind. Teqal, now fondly known as the jar people, is featured on our cover this month. The packaging company recently expanded its factory in KwaZuluNatal after the IDC awarded Teqal a R50m financing facility for its plant and capacity development project. We take a closer look at the entire expansion which is centred on sustainability and valued at R150m. Turn to page 12 for the full story. In the ingredient and formulation innovation feature on page 18, we highlight several ways in which changing consumer behaviours are influencing formulation formats and textures. For example, consumers demand brands to be accountable with greater transparency related to ingredient sourcing and manufacturing practices. We explore the impact of these trends, as well as self-care

and sustainability, on the ingredients supply chain and new product development. In the pharmaceutical focus on page 37, we bring you a variety of interesting articles on local and global industry developments. Marchesini Group expands into new technologies with its latest acquisition, digital solutions from Xeikon enable efficient short-run printing in the pharma industry and Syntegon and Huhtamaki collaborate on the launch of an innovative paper-based blister packaging solution, which is likely to appeal to the health- and environmentally-conscious customer in terms of its feel and appearance. As another challenging year draws to a close – it’s only fitting to wish our advertisers and readers well for the festive season. Thank you, from the team and me, for your continued support. We hope you have a good holiday. Please do your best to stay safe and enjoy the read!

CONTRIBUTORS: Karen Maier, Peter Hannah, Dershana Jackison, Ralf Schlözer

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SUB-EDITOR: Katrien Smit

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NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

Pharmaceutical & Cosmetic Review is published by New Media 11 times a year and circulates to manufacturers, packers and distributors of pharmaceuticals, health products, cosmetics, detergents, soaps, toiletries and allied products. The journal is an up-to-date source of reference for company directors, factory and production managers, marketing executives, engineers, import agents, buyers and research personnel. While precautions have been taken to ensure the accuracy of its contents and information given to readers, neither the editor, publisher, or its agents can accept responsibility for damages or injury which may arise therefrom. All rights reserved. © Pharmaceutical & Cosmetic Review. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, photocopying, electronic, mechanical or otherwise without the prior written permission of the copyright owners. Pharmaceutical & Cosmetic Review is printed and bound by CTP Printers - Cape Town Copyright: all rights reserved. ISSN 0257-8719


NEWS

AlcoNCP establishes Africa’s biggest fermentation distillery The AlcoNCP factory upgrade was a necessary progression to facilitate increasing African demand

Based in Durban, South Africa, AlcoNCP, a

the largest fermentation distillery on the

subsidiary of Alco, is proud to have completed

African continent while retaining its reputation

necessary progression to facilitate increasing

and commissioned the first large scale maize

as one of the world’s finest quality neutral

African demand and to reinvent the business

ethanol plant in Africa.

alcohol producers.

to ensure its relevance in the future with the

In 2019, AlcoNCP (formerly known as NCP

Ground on this epic undertaking was first

The AlcoNCP factory upgrade was a

core being the change of raw material and

Alcohols) embarked on a two-year expansion

broken in August 2019 and despite the outbreak

a more environmentally, sustainable and

project to change a crucial raw material in its

of the COVID-19 pandemic, the project was

energy efficient production plant.

supply chain from molasses to maize. The

completed according to schedule.

project, named the NCP100 Project, involved

“AlcoNCP is committed to what they

The expansion will forever transform AlcoNCP’s

do, investing in the latest production

the construction of a new distillery with a 55%

plant and processes with a capacity of 85 million

technology to support customer growth and

capacity increase and optimised energy usage.

litres of high-quality neutral alcohol for the food,

the NCP100 Project is a key milestone in the

beverage, cosmetic and pharmaceutical industries

group’s vision,” comments Peter Starling,

as well as a protein-rich animal feed, DDGS.

MD of the company.

The upgrade combines the latest technology, innovation and engineering, making AlcoNCP

Tel: +27 31 560 1111 Email: info@alconcp.com www.alconcp.com

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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NEWS

Vantage increases production capacity for mild surfactants With demand accelerating for natural

“Vantage is uniquely positioned to

personal care solutions, Vantage

deliver the differentiated ingredients

Specialty Chemicals has announced

that consumers are looking for in

it will increase production capacity

their personal care products,” said

for mild, sulfate-free surfactants and

Vantage CEO, Steve Doktycz. “Our

intermediates at its Leuna production

commitment to additional production

facility in Germany.

investment will benefit our customers

Alexander Snell, senior vice

as they seek to meet the evolving

president of Europe, Middle East &

needs of consumers. We are excited

Africa for Vantage, said the company’s

to lead this growing market and to

production plans will meet rising

continue to innovate and invest in

customer demand for mild and

natural ingredients and solutions.”

sustainable ingredients.

Metaupon surfactants are high-

“This production increase, which is

performance foam enhancers that

in addition to a capacity expansion that

create a rich, dense foam for mild

we completed in October 2020, will

rinse-off formulations. As part of this

enable Vantage to continue to reliably

range, Vantage provides the precursor

fulfil increasing demand for taurates,

N-Methyl Taurin, Sodium Methyl

particularly at a time when many

Cocoyl Taurate and Sodium Methyl

critical ingredient supplies are difficult

Oleoyl Taurate.

to obtain and consumer interests are changing,” said Snell. Vantage offers a strong value

Taurate surfactants are effective, sulfate-free alternatives favoured by formulators in applications targeting

proposition for customers looking

sensitive skin and scalp irritation

for sulfate-free surfactant systems,

because they’re extremely mild.

with leading technical expertise and

Metaupon surfactants also provide

formulation know-how for taurate

great skin feel and improve the overall

surfactants across its 12 global

sensorial experience in shampoos and

application labs.

body washes.

Chanel fragrance now packaged with a sustainable Sulapac cap Organised by the It all began with a desire. In 2018, Les Eaux de Chanel introduced a new olfactory world to the fragrances of the House: a singular collection, inspired by Mademoiselle Coco Chanel’s favourite places, fuelled by the imaginary and composed around freshness. Consistently, Les Eaux de Chanel was conceived with sustainability in mind. Its glass perfume bottles are thinner and lighter*, which means a smaller volume of raw materials and optimised transport, and the corrugated cardboard that is normally hidden was transformed into clean, simple outer packaging finished without lamination or a glossy coating, making it easier to recycle. Since 2021, all the 125mℓ bottles in the Les Eaux de Chanel collection are topped with a biobased** cap, which Chanel developed in partnership with Sulapac. For two years, Chanel teams worked hand-in-hand with the Finnish startup to create an unprecedented cap composed of three layers, made out of 91% biobased materials obtained from renewable resources and FSC certified*** wood chips (by-products of industrial side-streams). In keeping with the rigorous standards of the House of Chanel, every detail was carefully conceived, including the sensory nature of the material, its resistance to fluctuations in temperature, the unique sound the bottle makes when the cap is replaced, the grip, and the depth of the satiny matte finish on the iconic double C engraving. It took no fewer than

New rheology modifier for clean beauty formulas At a time when the cosmetics industry is experiencing growing demand from consumers for products that are more respectful to the skin and the planet, Seppic presents a new rheology modifier, Sepilus K. Launched globally for cosmetic application, this concentrated liquid polymer has been developed to give a touch of sensory elegance to particularly demanding formulations such as clean beauty.The rheology modifier was launched a year ago in Asia and has been enjoying great success in the market. It has been honoured with a 2021 Ringier Technology Innovation Award in China for its excellent performance and support of cold process formulation development. Sepiplus K is solvent, preservative and EO-free. As it is cold processable it requires very little energy for formulation, which is a considerable

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48 tries to reach the final product. The project is part of a long-term, collaborative approach that puts sustainability at the centre of Chanel research and development. Sulapac was pleased to welcome Chanel, a leading brand representing the most demanding luxury segment, among its early investors in 2018. “Chanel is definitely one of the forerunners in the luxury industry as they want to invest in the latest sustainable material and technology innovations. We have set a very high-quality standard for our sustainable material, with an

advantage for the development of more ecological products. Not considered a microplastic, Sepiplus K is supplied as a concentrated inverse emulsion. It provides high performance in terms of thickening, oil stabilising and resistance to electrolytes. It is pre-neutralised and efficient on a large pH range from 3 to 12. Sepiplus K imparts a silicone-like gliding skin feel with a non-tacky and non-sticky finish. In a study carried out in China based on the R3M score, Sepiplus K has been scientifically proven to instil positive emotions among consumers, which is an important factor in the appreciation of cosmetic products.

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

ambition to replace conventional plastics,” stated Suvi Haimi, CEO and co-founder of Sulapac. “This first product launch of our collaboration with Chanel, the biobased Les Eaux de Chanel cap made with Sulapac material, is a remarkable milestone for us. It proves that Sulapac meets the highest quality standards.” *Compared to other Chanel Eaux de Toilette of the same size. ** Made from plant-based materials. *** Wood from FSC-certified responsibly managed forests and other controlled sources. Sulapac’s FSC licence number is FSC-C158142.

All the 125mℓ bottles in the Les Eaux de Chanel collection are topped with a biobased cap, which Chanel developed in partnership with Sulapac


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COMPANY FOCUS

New packaging plant sets in motion a powerful sustainability strategy As a socially- and environmentally-responsible business, Teqal not only considers the impact of its packaging but also how the company operates as a whole. It has put in place ambitious sustainability targets and is committed to reducing its carbon footprint in various areas, ultimately setting a good example for others in the packaging industry. By Abby Vorster

An exterior view of the new 4 000m2 factory and warehouse located in KZN at the Dube TradePort Special Economic Zone alongside King Shaka International Airport

SUCCESSFUL INTEGRATION OF DEAF EMPLOYEES Since December 2020, Teqal has been partnering with eDeaf on the successful placement and integration of deaf employees within its workplace. eDeaf strives to improve the social and economic lives of the deaf community by create employable deaf individuals who are able to contribute to the economy.

E

arlier this year, the specialist producer of injection-moulded rigid plastic packaging expanded its factory in KwaZulu-Natal after the IDC awarded Teqal a R50m financing facility for its plant and capacity development project. When Teqal was established five years ago, it operated from a mini factory in the Dube Trade House, located alongside King Shaka International Airport. From within this facility, the company launched its flagship Reflections cosmetic jar, a 70% biodegradable and 100% recyclable option of the Reflections cosmetic jar, and the world’s first 500mℓ in-mould labelled jar for skin and body products. Teqal enjoyed rapid growth during this time, consistently pursuing its innovation pipeline, and within four years it needed a larger factory to call home. The excellent infrastructure and services of the Dube TradePort Special Economic Zone provided the ideal location for Teqal to establish substantially bigger premises.

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"Now fondly known as ‘the jar people’, Teqal’s expanded factory can produce up to 40m jars per annum" The new 4 000m2 factory and warehouse were custom designed according to the company’s requirements. The building is certified for the highest standard of fire safety and is constructed with sustainability in mind. For example, integrated motion-sensor LED lighting is fitted throughout and automatically turns on and off in response to movement. Teqal has also invested in new high-level energy-efficient European servo-driven equipment, which uses less energy during production. This is enhanced by a closed water management system, preventing any water from being consumed during the cooling process. There are also plans to install solar panels on the roof of the building as provisions

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

The successful integration of the deaf employees not only required effective communication measures to be put into place at Teqal, but also a workplace where their health, safety and accessibility are guaranteed. Along with learning basic sign language, the Teqal team was trained by eDeaf, and the company made changes to its IT systems to make the transition to an inclusive factory. have been made in the architectural structure to use renewable energy.

PLASTIC-NEUTRAL PARTNERSHIP Teqal’s drive to lower its carbon footprint extends beyond energy and water consumption, with the introduction of light-weighted bestin-class jars produced using less plastic. The company has also established a plastic-neutral partnership with Wildtrust through its Blue Port project, in which it strives to be 100% plastic waste-neutral. I.e., for every kilogram of plastic Teqal converts into packaging, an equal amount of post-consumer plastic waste (PCPW) is collected from the environment and recycled.


COMPANY FOCUS

The Blue Port project is an initiative of Wildoceans (a programme of the Wildtrust), with the aim of creating action-based research and the implementation of strategic interventions to reduce plastic waste in the Durban Port and ultimately restore the Durban Bay to its natural functioning state. “As a company, we are trying to find ways to reduce our carbon footprint – and striving to be plastic-neutral is certainly a big stride in that direction,” explains Sean Kirkham, sales and marketing director of Teqal. “Consumers are becoming more educated about problems linked to plastic pollution and they are beginning to push brands, which in turn push suppliers to be more environmentally-conscious. We are now leading the pack in driving the message of being waste-neutral. Government has also played a part in putting legislation in place that lets producers and retail companies know that they are also responsible for the waste generated by the plastic that they sell.” This legislation Sean is referring to is mandatory Extended Producer Responsibility (EPR), which came into effect on 5 November. The Section 18 regulations legally mandate packaging manufacturers or importers and brand owners to demonstrate their EPR by achieving set targets for managing their post-consumer packaging waste. This includes collection, sorting and recycling, with the goal of reducing the amount of packaging waste sent to landfill or which ends up littering the environment. Renee Kirkham, CFO of Teqal, is just as passionate about the plastic-neutral partnership as her husband, Sean. She comments: “Plastic is highly recyclable and highly reusable. If we can get to a point where we ensure plastic is reused and recycled, we can continue to reap the benefits of the solution it provides in packaging – but do it in a way that is sustainable. As a converter of plastic, it is important that we contribute to this initiative.”

Within the expanded factory, Teqal’s light-weighted best-in-class jars are produced using less plastic

EFFICIENT, INNOVATIVE AND SUSTAINABLE Now fondly known as “the jar people”, Teqal’s expanded factory can produce up to 40m jars per annum. This significant increase in manufacturing capacity is as a result of its investment in automation, which amounts to a third of the total cost of R150m for the new plant. The company has also invested in a new milling machine to cope with the increased demand in the toolroom. Its production processes have been designed to be sterile and hygienic to optimise material flow and limit the need for human presence in several key areas. Even changeover is streamlined with minimal downtime. These efficiencies are realised through modular processes, which Teqal developed and standardised in-house. The modular processes also allow the company to remain flexible enough to meet the needs of its smaller customers and they guarantee consistent product quality. Another area of innovation is its focus on reducing downstream costs by introducing a bagging system that eliminates cardboard boxes. At the end of Teqal’s production line,

The Teqal team at the Durban Port pictured with Wildtrust CEO and Wildoceans Blue Port project team. Standing left to right: Wendy Dunn (Blue Port project supervisor), Junior Mthembu, Anele Shabane, Nomzamo Ntini, Renee Kirkham, Sean Kirkham, Roelie Kloopers (CEO of the Wildtrust), Ntombifuthi Dlamini, Sihle Mdakane, Sabelo Mbatha (Blue Port boat skipper), and Rachel Kramer

A section of Teqal’s new streamlined warehouse

finished jars are auto-bagged in plastic sleeves in an orientated fashion. The plastic sleeves are then layer-packed for delivery to the customer’s facility. With one action of pulling the edge of the plastic sleeve through a slot, one layer of jars (144 units) is introduced onto the filling line in an automated, unhandled manner. Apart from the hygienic benefit of this innovation, eliminating cardboard boxes from the supply chain is helping Teqal’s customers to save millions of rands in box costs and the associated labour. These developments show that over the past 12 months Teqal has poured endless resources into producing packaging that is sustainable, into operating in a manner that is 100% environmentally-responsible and in establishing a partnership that speaks volumes of its extended producer responsibility efforts. Teqal is a prime example of a company that is actively working to completely alter the landscape in terms of the role and obligation of the packaging industry to protect the planet by having a net positive impact. •

Teqal – www.teqal.co.za

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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INDUSTRY TALK

South African pharma – a powerful destination for multinational investment In March 2020, IPASA commissioned a longitudinal study among its members to assess the impact of innovative multinational pharma companies operating in South Africa. The scientific achievements of local pharma companies are clear from the study data, underlining several areas where South Africa is a frontrunner on the continent, from increasing the availability of live-saving treatments to stimulating the economy.

S

outh Africa’s pharma industry is at the forefront of scientific advancement and constantly provides the country with innovative medical treatments. Industry players also invest in the latest research and development and support employment and skills transfer initiatives. These are just some of the reasons why South Africa is perfectly positioned to become a regional hub for pharmaceutical development in Africa.1 Bada Pharasi, CEO of the Innovative Pharmaceutical Association of South Africa (IPASA), explains: “Innovative multinational pharmaceutical companies (MNCs) are increasingly looking at South Africa as a regional hub for managing pan-African commercial operations and centralising functions across the territory. By encouraging this high Bada Pharasi, CEO of IPASA value-adding sector to base its regional headquarters here, the socio-economic benefits will be disproportionately greater than the local South African market value, with enhanced employment, knowledge transfer and investment value.” Compared to other Sub-Saharan African countries, the relatively good infrastructure and business-friendly environment of

14

"Innovative pharma MNCs are increasing their spend and sponsorship on healthcare programmes" South Africa have resulted in a significant and increasing number of MNCs viewing our country as a reliable base from which to support other African member states in need. This ensures enhanced access to the pipeline of innovative therapies of MNCs, benefitting more patients across the country and contributing additional GDP. 2

A CRITICAL KNOWLEDGE BASE “A sizable portion of the regional revenues generated by MNCs are being led from operations within South Africa by senior and regional management roles, which would otherwise be based in other countries,” Pharasi explains. Innovative pharma MNCs are increasing their spend and sponsorship on healthcare programmes, which target other member states from within our country. They do this

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by investing in existing skills and partner with local specialists and the scientific community to train and up-skill experts in those other countries. 2 Between 2016 and 2021, the number of healthcare programmes conducted from South Africa which targeted other countries, grew by 10.2% annually.2

MEDICAL INNOVATION SAVES LIVES “Pharmaceutical member companies of IPASA are constantly working on innovative medicines to treat illnesses,” comments Pharasi, adding that although some illnesses currently have no cure, advanced medical treatment is improving and extending the lives of patients, while new treatments are being developed all the time. The association’s member companies are also developing therapies to prevent a variety of conditions previously considered untreatable, including infectious

Did you know? Products from SA’s innovative multinational pharma companies generate substantial revenues for manufacturers, distributors and other suppliers. Since 2016, these revenues have grown annually by 3.6% on average. By the end of this year, these pharma companies will have generated over R20.6bn in revenue for their manufacturing and distribution partners and other direct business partners.


INDUSTRY TALK

POSITIVELY IMPACTING MANUFACTURING AND INVESTMENT • Local production among innovative pharma companies is valued at over R17.9bn with investment at R1.3bn, growing at a CAGR of 42.5%. • These manufacturers make a direct contribution of over R5.4bn to the South African state budget and develop R20.6bn+ in revenue for third party suppliers to the industry. • Innovative pharma companies in SA generate R56bn of direct manufacturing and importation costs and R11.1bn of indirect costs. • Investment in knowledge transfer projects by IPASA member respondents is estimated at R82bn. Overall, operational expenditures made by the respondent multinational pharma companies between 2016 and 2021 amounted to R154.5bn+1. Source: Longitudinal Study Commissioned by IPASA, March 2020 diseases, various forms of cancer and neurological disorders. Medicines developed by innovative pharma benefit millions of South Africans on a daily basis. For example, the country’s mortality rates for HIV/AIDS and TB fell by 59.2% and 55.7% between 2007 and 2017.3 Currently, at least 60 new medicines are in the research and development pipeline to treat TB.3 Chronic leukaemia treatment has also seen increased survival rates thanks to the drug that was created to treat chronic myeloid leukaemia (CML). It was later found that this drug was even more beneficial when treatment commenced immediately. With further research, the drug was then shown to be useful in treating other forms of cancer. Patients are now living close to normal life spans and cancer death rates have declined by 27%. Approximately 73% of survival gains in cancer are attributable to new treatments, including medicines.3

"There are currently over 4 100 new medicines for NCDs in the local research-based pharmaceutical pipeline" In South Africa, non-communicable diseases (NCDs) are responsible for 43% of deaths. Of this, a third of the deceased were people under the age of 60 and many of the cases were related to cardiovascular disease. There are currently over 4 100 new medicines for NCDs in the local researchbased pharmaceutical pipeline, including medicines to treat heart disease, strokes, cancer and more.3

NOVEL IDEAS INCREASE ACCESS TO MEDICINES IPASA member companies are also responsible for bringing innovative, quality medicines to the South African market, through their exploration and development efforts. For example, Novartis introduced Novartis Access, which is a portfolio of affordable medicines to treat chronic diseases in lower-income countries. In a first-of-its-kind portfolio approach within the healthcare industry, Novartis is increasing the availability of 15 medicines to treat cardiovascular diseases, diabetes, respiratory illnesses and breast cancer, by making them more affordable. Another example is that of MSD, a healthcare and pharmaceuticals group, which has a vision to eradicate cervical

cancer. The company is evolving from just treating cancer to implementing a more preventative approach. This development is of great significance, considering that almost one-third of deaths in Sub-Saharan Africa are due to cervical cancer and yet only 14% of the world’s women live in the region.5 MSD has active programmes treating cervical cancer across 13 of the 35 countries in which it operates, yet these have been disrupted by the pandemic. In terms of augmenting global efforts in the fight against COVID-19, MSD is focusing on an investigation for an antiviral drug. The drug would not replace vaccinations – instead it would work hand in hand with them. It’s currently in the phase three clinical trial stage for the treatment of non-hospitalised patients with confirmed COVID-19.5

INVESTMENT, SALES AND R&D “MNCs spend a high percentage of revenue on R&D compared to other sectors. This R&D delivers social and health benefits as well as financial stimulus for the country’s economy,” notes Pharasi. “South Africa’s volume and proportion of clinical research activity sets the country apart from its peers in the Middle East and Africa, as a more scientifically developed economy and society. This makes South Africa a favourable destination for investment, education and access to innovative health solutions and improves our country’s ‘soft power’ within Africa and in the global pharmaceutical community.” Apart from providing innovative medical treatment to South Africa and the African continent, it is clear that MNCs play a vital role in our country’s economy and are essential to the provision of sustainable and inclusive economic growth.6 • REFERENCES: 1. Footprint Study March 2020. Impact of Innovative Multinational Pharmaceutical Companies Operating in South Africa – Longitudinal Study Commissioned by IPASA 2. Ibid 3. Ibid 4. Financial Mail 2021. Profile: Zwelethu Bashman is Fighting Covid and Cancer, by Patrick Wadula 5. Ibid 6. Footprint Study March 2020. Impact of Innovative Multinational Pharmaceutical Companies Operating in South Africa – Longitudinal Study Commissioned by IPASA

IPASA – https://ipasa.co.za

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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INDUSTRY TALK

Cobots – lending a hand at the end of the line Of the many processes involved in finalising a consumer product, the final step can be the most intricate. For one Omron customer, the last step on its electric shaver production line is to fasten the cover holding screw, closing the unit. Traditionally, the full process was completed manually, with an electric screwdriver in a multi-step process. However, with an Omron cobot, the customer has been able to automate the repetitive task.

W

hen a leading global manufacturer of personal care equipment needed a production solution that combined cost reduction with quality improvement benefits, it turned Omron. The manufacturer and Omron have a long-standing relationship as they have worked together many times previously. For this particular line, the manufacturer needed a solution to assist with a specific task, right at the end of production. The task was the tightening of the final screw inserted into a personal grooming device. Despite the simplicity of the task, on a manufacturing line it’s relatively intricate, requiring great care, accuracy and attention to detail. The task also involves differing form factors and models, with the placement of screws differing per model, which is why the task was performed manually in the past.

by a Sistema calculation to define the requirement specifications for the system integrator,” adds Oorbeek. “From there, we were able to prioritise and plan for the commissioning phase of the project.”

SELECTION AND SETUP “In the setup phase, we used the intuitive plug and play software to establish virtual

"The cobot was able to instantly and accurately sense the results of its actions"

DEFINING THE REQUIREMENTS “The customer approached us to see if it was possible to bring in a collaborative robot to help the operator,” comments Barry Oorbeek, key account manager industry solutions at Omron Benelux. The solution design phase involved a thorough audit of needs. “Omron Safety Services Europe first conducted a machine risk analysis followed

16

Safety was a primary requirement for the customer, as the cobot works in close proximity with a human operator

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA


INDUSTRY TALK

when the screw was firmly in place, without overtightening it. Since everything is programmable, once the actions are performed perfectly, they are fixed in memory to be actioned repeatedly and correctly going forward.

IDEAL HUMAN-COBOT MIX

‘safety fences’ prior to installation. This set clear boundaries around the cobot, to limit its range of movement to the specific area of operation,” he explains. Putting these measures in place ensured complete predictability and customer confidence in the outcome. It also gave the operator an understanding of where the cobot would be and what it would be doing at all times.

SAFETY FIRST For the customer, safety was of course a primary requirement, since the cobot would be working in close proximity with a human operator. The customer selected the Omron TM5-700 from the various options suited for the task. This unit is built for quick startups, rapid changeovers and inherent safety. Oorbeek adds: “From the points highlighted in the machine risk analysis, Omron Safety Services Europe then conducted extensive force- and pressuretesting, going through each potential risk point, establishing the maximum permissible pressure, and confirming that the cobot was able to instantly and accurately sense the results of its actions.” The testing covered all the delicate movements involved in screwing the unit cover into place, so the cobot would detect

A QUICK, COST-EFFECTIVE AND HELPFUL SOLUTION Collaborative robots (or cobots) are easy to set up and offer a quick and cost-effective solution. They can increase the flexibility, quality and

An intuitive human-machine interface within the machine controller gives full overview and control of the cobot, which is designed for ease of use. Operators need only five minutes of instruction before starting to work with the system, which has been

speed of production and enable

engineered to keep pace with the speed of the manual production line. According to Oorbeek, this system goes a long way to solve a very common problem in production lines. “Repetitive tasks done by hand can suffer from a variation in quality over time. With this solution, the customer reaps the benefit of an ideal combination of the flexibility of an operator to handle the high diversity of components, with the accuracy and sensitivity of the Omron cobot to perform the repetitive screwfastening process.”

robots. In contrast to traditional

changing market conditions. Omron’s series of cobots are a good example of this versatility. Cobots were first introduced in 2008 and represent a relatively new category of industrial robots, which have to be shielded from the human workspace by a security fence, cobots are developed to work safely with people. Users also need less time and money to programme an application with these helper robots. Omron’s cobots are also highly versatile and straightforward. The different versions are suitable for practically any environment, such as the automotive, semiconductor, food, packaging and cosmetics

WHY NOT FULLY AUTOMATE? In this case, the customer already has a large fleet of Omron robots installed with some automated screwdriving on automated lines. However, the particular workstation discussed in this case study is used for a variety of form factors and end-products, so a decision was made to bring a cobot on board, since there may be multiple changes per day in terms of the product that’s being finalised. “Omron cobots are designed to be supremely flexible, both in the way they are simple to programme and how they can be used. In this instance, the customer can achieve single-minute exchange of dies, moving from one product type to another extremely quickly,” Oorbeek says. The end result of this project is “a delighted customer”. Its process quality has improved, and the integrated solution was quickly verified and validated.

manufacturers to respond rapidly to

sectors. Due to the flowchart-based programming, an intuitive HMI user interface and simple, hand-guided teaching functions, almost no previous knowledge of programming is required. Many core functions (such as pattern, barcode and colour recognition) enable detection, inspection, measurement and sorting applications to be implemented easily and, if necessary, adapted to other requirements.

Thanks to the success of this project, the customer is currently investigating the use of Omron cobots in other areas of its production facilities. • Omron – www.industrial.omron.co.za

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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INGREDIENT & FORMULATION INNOVATION

Formulations to amplify self-care in 2022 Mindfulness and beauty have become entwined. As the self-care trend that everyone is trying, nurturing their beauty needs gives consumers comfort and a sense of wellbeing during a time when needed most. Karen Maier of Merck South Africa explores new product development ideas to create innovative skin and body care products centred on the concept of at-home spa rituals.

T

he foundation of wellness as we know it today was laid millennia ago in ancient India and China with Ayurveda and traditional Chinese medicine. In the 1950s and 1960s, likeminded doctors and scientists in the US revisited these concepts, however, the idea only really gained traction over the past 20 years. Now, with the coronavirus pandemic, the concept of wellness and the art of self-care have been brought to the fore as people are increasingly stressed and have been unable to visit their favourite spa or wellness centre during lockdown. Working from home, blurring of the lines between our professional and private lives, and the stress of the uncertainty of these times have caused consumers to turn to self-care as a form of therapy and way to relax. At-home spa rituals have become mainstream and consumers now expect more from their beauty products, demanding innovation to make the experience more enjoyable. The sensory experience has become paramount, resulting in new concepts and

18

Did you know?

According to a study by Ogilvy, 41% of consumers say wellness claims sound believable and 80% want more wellness, and 75% say brands don’t offer enough wellness.

formats becoming highly desired in the beauty category.

TEXTURES, FORMATS AND INGREDIENTS Food-inspired textures like jellies and gels are particularly popular. These feel fresh on skin and are easy to apply. Transforming textures, such as gel-tomilk, cream-to-water or powder-towater, add an element of surprise to the home-spa rituals. A sensation of luxury is also high on the list of demands; products should glide onto skin with a soft, velvety touch. Interesting formats matter because they create a sense of curiosity and enhance the beauty mood. There are many options for innovation – choose from spray-on formats such as serum

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

mists, sprayable face masks and body sprays; or waterless formats that offer a wide range of possibilities for sustainable products. Concentrated active formulations and spa-like textures are additional options, as well as DIY concepts. These involve consumers in creating or customising products for themselves, adding to the sense of self-care and feeling of wellbeing while satisfying a curious mind.


INGREDIENT & FORMULATION INNOVATION

Table 1: Natural cleansing gel-to-milk (MSAS.816.07.04.17) Phase

A

B

C D

Ingredients

INCI EU

%

RonaCare Ectoin

Ectoin

0.10

RonaCare Potassium Sorbate

Potassium Sorbate

0.50

RonaCare Sodium Benzoate

Sodium Benzoate

0.50

Glycerol 85%

Glycerin, Aqua

Water, demineralised

Aqua

4.00

Surfhope C-1216

Sucrose Laurate

2.50

Surfhope C-1816

Sucrose Stearate

Organic Sweet Almond Oil

Prunus Amygdalus Dulcis Oil

23.20

Myritol 318

Caprylic/Capric Triglyceride

24.00

Cetiol C5

Coco-Caprylate

15.00

RonaCare Bisabolol nat.

Bisabolol

0.50

all-rac-alpha-Tocopherol

Tocopherol

0.20

Citric acid, 30% solution

Aqua, Citric Acid

ad 100

2.50

q.s.

ULTIMATE HOME-SPA FORMULATIONS Ingredients matter, too – effective ingredients backed by science also play a major role in the self-care trend. Nature-based and nature-inspired ingredients, vitamins and minerals, or ingredients with immediate visual benefits are favoured. Fragrances that support aromatherapy claims also stand out. Formulators should take note that products that enhance relaxation while providing functional beauty benefits will ultimately be successful.

The first, but very crucial step, in a home-spa ritual, is cleansing. Innovative formulas that add a sense of fun, pique curiosity and add to an overall feeling of wellbeing are the way to go. A prime example is a natural gel-to-milk formulation based on a transforming texture, i.e. when water is added the gel turns into a milk (see Table 1). By adding

" Transforming textures, such as gel-to-milk, cream-towater or powder-towater, add an element of surprise" natural actives such as RonaCare Ectoin and Bisabolol, the product may offer very gentle yet effective support to the skin. Next comes a mask, which is still very much on-trend. Claims such as moisturising, brightening and detoxifying remain extremely popular for facial masks. Different generations apply masks for different reasons. Gen Z users are huge fans, sharing their experiences on social media as they explore various beauty routines. Consumers who are older crave hydration, firming and even skin tone benefits. It’s not surprising men are also turning to masks to up their

Table 2: Water-soluble clay stick mask for rough skin (MT-Mask 200804C) Phase

A

B

C

D

E

Ingredients

INCI EU

RonaCare Ectoin

Ectoin

Water, demineralised

Aqua

Dipropylene Glycol

Dipropylene Glycol

15.00

DC 2511 Cosmetic Wax

BIS-PEG-18 Methyl Ether Dimethyl Silane

12.00

Sodium Stearate

Sodium Stearate

5.00

Glycerin

Glycerin

5.00

Xanthan Gum

Xanthan Gum

0.30

Water, demineralised

Aqua

Veegum HV (4%)

Aqua, Magnesium Aluminum Silicate

5.00

Tego Betain F 50

Cocamidopropyl Betaine, Aqua

5.00

Tegosoft PC 41 MB

Polyglyceryl-4 Caprate

2.00

RonaCare AP

Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate

0.50

RonaCare Poppy SE

Caprylic/Capric Triglyceride, Papaver Rhoeas Extract, Tocopherol

2.00

RonaCare Bisabolol nat.

Bisabolol

0.30

RonaFlair Satin

Illite

Ronastar Dazzling Lights

Alumina (or Synthetic Sapphire), CI 77491, CI 77891, Tin Oxide

Preservatives

% 0.30 ad 100

15.00

16.00 1.00 q.s.

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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INGREDIENT & FORMULATION INNOVATION

Table 3: Calming spray for hypersensitive skin (MDA-A-181-10) Phase

A

B

C D E

Ingredients

INCI EU

Polyaldo 10-1-0

Polyglyceryl-10 Oleate

3.00

Lanol 37 T

Triheptanoin

1.00

Dub Aprilose +

Apricot Kernel Oil Polyglyceryl-4 Esters

3.00

Pelemol Dism

Diisostearyl Malate

2.00

Avicel PC 611

Microcrystalline Cellulose, Cellulose Gum

1.00

Rhodicare XC

Xanthan Gum

0.20

Water, demineralised

Aqua

RonaCare Potassium Sorbate

Potassium Sorbate

RonaCare Benzyl Alcohol

Benzyl Alcohol

Citric Acid

Citric Acid

RonaCare Balmance

Maltodextrin, Centaurea Cyanus Flower Extract

3.00

Zemea Propanediol

Propanediol

5.00

"Presenting a mask in an unusual way, such as a “touchless” stick mask, is sure to appeal to homespa aficionados" skin care game. Presenting a mask in an unusual way such as a “touchless” stick mask, or a DIY peel-off format, is sure to appeal to home-spa aficionados. The list of active ingredients which can be included in masks is almost endless. RonaCare AP, which protects sebum components of the skin leading to anti-seborrheic and anti-inflammatory activity, is a great addition to a clay mask (see Table 2). RonaCare Luremin,

20

%

ad 100 0.60 1.00 q.s.

a nature-identical active that improves skin elasticity and moisture, can be used in an overnight sleep mask, a rich composition hidden in a light gel texture. Ronaflair Functional Fillers are another great addition to face mask formulations. The range includes oilabsorbing and mattifying options, and texture-improving products such as Ronaflair Satin, which enhances the silky and velvety texture of a mask; or Boroneige SF-3, which promotes a pleasant skin feel. After indulging in a mask, the next step is to apply a face cream. With the soothing skin ice cream, one essentially builds on the foundation laid by the mask, as this product literally melts on the skin to pamper and soothe even the most demanding skin, leaving it radiant and ready for a busy day. This interesting texture can be paired with several active ingredients such as RonaCare Balmance, a skin comfort stabiliser, to reduce redness and itchiness; RonaCare CP-5, a unique cyclic peptide that counteracts fine lines and wrinkles with absolute precision; or RonaCare Allantoin, which offers rebuilding, smoothing and moisturising properties.

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ON-TREND BODY SPRAYS Self-care efforts don’t stop at the face, extending to body care products which have become firmly entrenched in the home-spa routine. Consumers want body products based on scientifically-proven ingredients, taking inspiration from facial care when choosing their products. As a result, body masks, scrubs, serums and body oils are all on-trend. Body sprays are highly desirable right now – these products are popular because they are contactless, which is a perfect trait for the pandemic. Body sprays are also very light, easily and quickly absorbed, and do not leave a sticky residue on the skin (see Table 3). While mostly everyone uses body lotion, not all body lotions are infused with luxury conveyed through premium actives added to the formulation. For example, RonaCare RenouMer, a marine-based beauty active, stimulates collagen synthesis, enabling a superior redensifying effect, which ensures firm skin on the body and not just on the face and neck. Beauty consumers are taking pampering seriously, and market research shows that as an industry this is the right thing to do. It is time to find novel formulations, textures and formats that pamper, repair and protect skin while entertaining consumers, ultimately ensuring they keep coming back for more. • Merck – www.merckgroup.com


INGREDIENT & FORMULATION INNOVATION

Ceramides for all tones and textures

Beauty products should be for the young and old, men and women, all races and skin types, for those with straight and curly hair and everyone in-between. That’s why Evonik’s skin-identical ceramides are good for all skin and hair types worldwide, making these ingredients truly inclusive. Their wide variety of applications allow for an equally wide variety of care products.

T

Did you know?

he beauty industry has picked up on the movement of inclusion to foster beauty in all its facets and to present consumers with diverse cosmetics. From celebrities like Rihanna with her Fenty Beauty line to smaller independent labels, inclusive beauty is here to stay. It gives new and

Ceramides occur naturally in the skin and hair where they lock in moisture and seal out impurities for a healthy, smooth and radiant look. If you’re curious about how Evonik’s ceramides can unlock new possibilities in your formulations, take a look at this web page: https://bit.ly/3Gm97nU.

established brands a chance to be part of the revolution and to lastingly expand their circle of customers with formulations and system solutions that address different needs and know neither skin type nor hair type. Evonik also believes that healthy skin and hair should be applicable to all ages, genders, hair types and skin colours and that beauty products should include solutions for all consumer groups.

processes and develops the right system solutions and formulations to make beauty products effective. With its range of ceramide and sphingolipid technologies, Evonik has developed active ingredients that are proven to help enhance and strengthen all types of skin and hair. Inspired by the various needs of consumers, Evonik produces pure skin-identical ceramides suited to a variety of applications. These technologies protect against moisture loss and external changes by reinforcing

AIR DECODED SKIN-IDENTICAL CERAMIDES

As a leading manufacturer of cosmetic active ingredients, Evonik conducts fundamental research into ceramide technologies. The company continues to decipher natural

the natural lipid barrier of dry, sensitive or ageing skin and hair. They also replenish by counteracting photodamaged skin and reducing inflammation, and strengthen skin from the stratum corneum to the subcutis. Furthermore, they reduce hair breakage and shield hair fibres from mechanical and thermal stress.

RECOGNISE DIVERSITY GLOBALLY Beauty comes in all types and forms and consumers increasingly require products that cater to this principle. That’s why inclusive beauty will continue to be crucial to all cosmetics manufacturers now and well into the future, not only to address the needs of their customers, but to also remain competitive. Therefore, it’s all the more important to recognise diversity and to produce inclusive care products that represent all people worldwide. •

Evonik – personal-care.evonik.com/en

SKIN AND HAIR DECODED

ded

Ceramides by Evonik

SKIN AND HAIR DECODE

08.10.21 10:34

www.evonik.com/ceramides-decoded

René Spada rene.spada@evonik.com

Ceramides by Evonik

www.evonik.com/ceramides-decoded 08.10.21 10:34

www.evonik.com/ceramides-decoded

21-01-161 -02- Anzeige Ceramide 262x68.indd 1

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INGREDIENT & FORMULATION INNOVATION

Innovative silicone replacements based on hydrogenation technology

The Innovation Company has more than 30 years’ experience in developing and producing a wide and functional range of innovative cosmetic raw materials. It aims to make the cosmetic industry safer and more scientifically aligned with its new Psiflow products of silicone substitutes.

A

ccording to The Innovation Company, silicones are considered substances of very high concern because they are known to “block skin breathing”. This is not desirable in skin care products as skin breathing represents approximately 8% of total body breathing. In September 1997, the FDA banned D-4 for dermal cosmetic applications. In June 2018, the ECHA regulated the use of D-5 and D-6 in cosmetic applications to a maximum of 0.1%. Despite the aforementioned concerns, the global demand for silicones is predicted to remain strong while pricing for silicone ingredients continues to soar. Several other factors are also impacting supply, including the shortage of silicon metal, power restrictions in main manufacturing centres and the overhaul of some silicone monomer plants.

Around 60rpm, The Innovation Company’s Psiflow products provide the same lubricating effect as benchmarks, which means that the skin feel upon application is perfectly replicated

GLOBALLY-APPROVED, READILYAVAILABLE ALTERNATIVES Considering the high prices and worldwide shortages of various silicone grades including fluids and volatiles, the industry is in desperate need of alternatives. The new Psiflow products from The Innovation Company join its Dedraflow, Vegeflow and Novatext ISO 16128 series, to offer the widest range of silicone substitutes, with over 125 references.

"Each grade has been developed uniquely using tribology and rheology, in order to achieve perfect viscosity, volatility, texture and skin feel"

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NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

Psiflow 5 increases hair volume by 12%, whereas cyclopentasiloxane decreases hair volume by 10%

These replacements of cyclomethicones, dimethicones and silicone elastomers are based on hydrogenation technology. Each grade has been developed uniquely using tribology and rheology, in order to achieve perfect viscosity, volatility, texture and skin feel. The Psiflow products provide all the benefits of silicones, including: • volatility • stability to light and oxygen • odourless and tasteless • ease of emulsification • compatibility with most cosmetic ingredients • smooth and non-greasy skin feel. Approved worldwide, the Psiflow products do not contain substances of very high concern and are non-bioavailable. Ingredients and formulation technologies from The Innovation Company are available in South Africa from Afrisil Speciality Ingredients. •

Afrisil Speciality Ingredients – karin@afrisil.com The Innovation Company – theinnovationcompany.fr


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INGREDIENT & FORMULATION INNOVATION

Green chemistry surfactants offer significant environmental benefits

Earlier this year, Colonial Chemical was honoured with an EPA Green Chemistry Challenge Award in the category ‘The Design of Greener Chemicals’. The company was recognised for its SugaBoost surfactant blends, which utilise more eco-friendly chemicals than traditional cleaning surfactants.

M

any surfactants used in traditional cleaners are derived from petroleum-based raw materials and pose several environmental issues including high toxicity. Energy-intensive processes are also required to manufacture these conventional surfactants. Yet, when producing SugaBoost surfactants, less energy is consumed, and they are biodegradable and derived from plant-based materials. Thanks to their performance, they show great potential as replacements for EO-containing surfactants, such as SLES and APEs. “Colonial’s SugaBoost technology platform is an example of a decades-old commitment to the design of greener, safer and effective surfactants for our customers and consumers,” said David Anderson junior, president of Colonial Chemical. “We are honoured to be recognised for this achievement and will continue to design and innovate in this space, which is critical for the world.”

ECO-FRIENDLY AND EFFECTIVE One group of chemicals often found in cleaners is alkylphenol ethoxylates (APEs). The US Environmental Protection Agency has identified this class of chemicals as toxic to aquatic organisms, especially because they bioaccumulate in molluscs, soils and sediments. Additionally, APEs can mimic natural hormones and induce endocrine disruption in aquatic and land organisms. In search of an alternative, Colonial Chemical discovered that the cleaning performance of blends of functionalised alkyl polyglucoside (APG) surfactants is equal to or better than APEs. APG surfactants also avoid environmental

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Table 1: Eco-friendly hand and dishwashing liquid (No. 4041) Step

INCI Name

Trade Name

%

1

Aqua

Water

2

Cetyl Hydroxyethyl Cellulose

Cetyl Hydroxyethyl Cellulose

3

NaOH, 50%

NaOH, 50%

q.s.

4

Functionalised Alkyl Polyglucoside

SugaBoost 050

15.0

5

Citric Acid, 50%

Citric Acid, 50%

q.s.

q.s. to 100 1.50

This high-performance eco-friendly hand and dish soap formulation incorporates SugaBoost 050, which is gentle on skin yet powerful enough to remove food soils and other proteins

issues related to aquatic toxicity, endocrine disruption and carcinogenic impurities. SugaBoost surfactants are blends of derivatised APGs prepared by attaching functional groups such as sulfonate, phosphate, quaternary ammonium, glycinate and citrate. These blends do not yield toxic substances as they biodegrade.

" SugaBoost surfactants are mild and safe, both for the formulator and end-user" SugaBoost surfactants are mild and safe, both for the formulator and end-user. Lastly, their manufacturing process is a lot less energy intensive with just water needed as a solvent during production and clean-up. These functionalised APG surfactants have the potential to replace EO-containing surfactants worldwide and their application could potentially be expanded into wipe

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

products, disinfecting cleaners, dish washing and carpet cleaning products, and fabric care.

SUGABOOST 030 AND 050 Both the 030 and 050 variants are naturallyderived surfactants. SugaBoost 030 is suitable for hard surface cleaners and food degreasers, while SugaBoost 050 is best suited to laundry and naturally-based exterior cleaning formulations, such as the ecofriendly hand and dishwashing liquid featured in Table 1. The cleaning performance of SugaBoost 030 and 050 in removing food soils, animal grease and protein soil is higher than traditional surfactants, such as DDBSA, SLES and NP-9. Both also meet market demands for high-performance green cleaning formulations. SugaBoost 030 and 050 are 1,4-dioxane-free; have mild characteristics in comparison to regulated surfactants like sulfates, alcohol alkoxylates, coco DEA and betaines; and are stable in hydrogen peroxide. Colonial Chemical’s SugaBoost surfactants are available in South Africa from Vantage. • Vantage – kim.maccallum@vantagegrp.com


INGREDIENT & FORMULATION INNOVATION

Filler-binder optimises production of fizzy tablets and powders Beneo’s galenIQ 721 filler-binder overcomes challenges in effervescent dosage manufacturing. The excipient is easy to use and it has improved technical properties.

T

o improve the taste and stability of effervescent tablets and powders, Beneo presents galenIQ 721. This filler-binder enables pharmaceutical and nutraceutical manufacturers to target consumers who have difficulty swallowing standard tablets. As a non-hygroscopic, water-soluble and directly compressible excipient, galenIQ 721 also provides high content uniformity and production efficiency for effervescent applications.

dissolve upon contact with water to release carbon dioxide and create a drink. In addition, they can be used to formulate pharmaceuticals that are difficult to digest, cause stomach or oesophageal irritation or which rely on a rapid onset of action, such as analgesics. While the dosage form is highly convenient, manufacturing effervescents can be challenging. A non-hygroscopic, direct compression filler-binder such as galenIQ 721 is needed to produce highly stable tablets. This excipient ensures high content uniformity and facilitates production. It also has a sugar-

A CONVENIENT AND APPEALING DOSAGE FORM Effervescent dosage forms offer distinct advantages compared to traditional tablets. For instance, many patients have problems swallowing tablets. Effervescent powders and tablets offer a more convenient way to deliver medicines or dietary supplements. They

"galenIQ 721 provides high content uniformity and production efficiency for effervescent applications"

like taste profile, a pleasant mouthfeel and can enhance the palatability of effervescent formulations. Available locally from Savannah Fine Chemicals, galenIQ 721 is non-cariogenic, sweet and tooth friendly.

ENHANCED PRODUCT DEVELOPMENT Dr Maj-Britt Cepok, head of business development, pharma, Beneo, comments: “Fizzy tablets are ideally suited to administer a wide range of light- and oxygen-sensitive active ingredients and those which require a large dose. In addition, effervescent preparations are more appealing to consumers than traditional dosage forms. galenIQ 721 helps manufacturers to tap into this market and enhance their development programmes.” •

Beneo – www.beneo.com Savannah Fine Chemicals – www.savannah.co.za

CUTTING EDGE TECHNOLOGY C

M

HIGH QUALITY INGREDIENTS FOR WELLNESS INDUSTRIES

Y

CM

MY

CY

CMY

K

RELIABLE – CONSISTENT – SUSTAINABLE – QUALITY DRIVEN

From basic ingredients to specialty actives for key application areas, such as:

Capsules | Tablets | Liquids | Syrups | Emulsions | Creams | Pastes Johannesburg: +27 11 856 4500 Cape Town: +27 21 830 5306

Durban: +27 31 202 0794 Email: info@savannah.co.za

www.savannah.co.za

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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INGREDIENT & FORMULATION INNOVATION

A cost-effective, sustainable additive to increase product performance The trend towards more sustainable detergents translates into a need for biodegradable and bio-sourced materials that perform well in this application. One approach to enable more sustainable products relies on high-yield additives, such as rheology modifiers or structurants. These ingredients help formulators to do more with less.

A

ECI Specialty Chemicals is at the forefront of sustainable home care solutions and offers an array of product options for this purpose. One such product is SupraCare 780. This multi-functional and sustainable additive combines rheology and structuring benefits. SupraCare 780 acts as a highlyefficient thickener in liquid detergents and a structuring agent in detergent bars, improving their physical and wear characteristics. The additive is a cellulosic-based material, derived from natural raw materials. It is deemed inherently biodegradable as per OECD 302B. Due to its non-ionic structure, Supracare 780 is highly compatible in formulations and can be used in liquid laundry detergents, hand dishwashing liquids, hard surface cleaners, laundry bars, multi-purpose bars and non-soap detergent bars.

ENHANCED BAR SOAP PROPERTIES The additive’s multiple benefits are easily realised in detergent bars. For example, Supracare 780 enables the total fatty matter (TFM) content of a bar formulation to be reduced by 5% to 10%. Its structuring and water-binding properties allow for reduced wear and cracking, providing a longer-lasting bar. Figure 1 shows the working hypothesis of combined structuring in order to achieve this optimum performance. The images demonstrate what happens to a bar soap when water is added during use. The percolated brick structure can be seen on the left shrink as the mortar is diluted and the bar softens – this is due to the loss of the percolated structure. Sodium silicate allows the bar to harden as the bricks grow, and yet as the structure returns there is no cohesive force, which results in the bar being brittle.

26

Figure 1: The structuring and water-binding properties of SupraCare 780 in bar soap compared to Sodium Silicate

"SupraCare 780 acts as a highly-efficient thickener in liquid detergents and a structuring agent in detergent bars"

Table 1: Bar soap formulation Ingredient

Soap noodles 80:20 (76% active)

Dow formulation

% w/w

% w/w

85.25

69.25

8

8

0.75

0.75

Fragrance and dyes

1

1

SupraCare 780 Additive

0

0.5

Water

5

20.5

100

100

Sodium Silicate (50%) Titanium Dioxide

Total

By adding Supracare 780 to a bar soap formula, it enables a wellstructured mortar which is able to regain bar cohesion. In the formulation guide in Table 1, 0.5% Supracare 780 is recommended for a bar soap with a TFM that is reduced by 16%. In addition to the reduction of TFM, the bar also shows improved properties, such as a reducing the rate of wear up to 35% and increasing the foam generated by 10%. Foam is one of the most important attributes of a laundry bar, connecting a visual cue with an impression of cleaning.

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

Control

A COST-EFFECTIVE TECHNOLOGY Supracare 780 can also be used in a hand dishwashing liquid. The increased rheology gives the hand dishwashing liquid a premium feel while superior foaming is also evident. The additive offers an enhanced consumer experience in liquid detergents by improving rheology and foaming. In detergent bar formulations, TFM can be reduced whilst enhancing the properties of the bar. Supracare 780 is a useful technology for creating luxurious home care products with minimal additional costs. • AECI Specialty Chemicals – Karen.Meyer@aeciworld.com


INGREDIENT & FORMULATION INNOVATION

UVB filter launched to advance innovation in eco-friendly sun care products Royal DSM, a global purpose-led science-based company, recently launched Parsol EHT. This highly efficient, eco-friendly UVB filter embodies the vision for DSM’s future-proof, eco-friendly portfolio.

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ith an E1/1 peak of >1500 in the UVB range, according to DSM, Parsol EHT delivers the highest absorption in the market today and is compatible with other organic and inorganic UV filters. The new UVB filter is also photostable and inert. These key benefits enable sun care formulators to achieve a desired SPF at low use concentrations and to develop a broad range of the highest eco-class formulations. While the COVID-19 pandemic has negatively affected category sales, market research companies project steady sun care growth between 3.5% and 6.2% for the next few years, thanks to growing consumer awareness of skin health and skin ageing concerns associated with UV exposure.1,2 According to Mintel, sun care brands should capitalise on the accelerating wellness trend and focus their innovation efforts on the skin care space by exploring multi-protection products with appealing textures and more disruptive eco-concepts.3

AESTHETICALLY PLEASING AND ON TREND With the launch of Parsol EHT, DSM is setting the pace to address current consumer and customer demands with on-trend, highly effective solutions. The UV filter scores high for UVB absorbance and eco-friendliness, the latter of which has been evaluated based on the persistence, bioaccumulation and toxicity data in DSM’s Sunscreen Optimizer™ tool. In addition to the high functional profile, it is easy to formulate, photostable and compatible with

SUNSCREEN OPTIMIZER To help sun care producers assess the environmental friendliness of their formulations, DSM’s Sunscreen Optimizer – which has more than 3 500 users in 98 countries and carries out more than 500 000 calculations annually – has been updated with an integrated eco-profiling feature and ready-to-use eco-labels. The tool is available online, free to use and designed to provide customers with a quick, efficient and cost-effective way to select and combine UV filters and enhance the performance of their sun care formulations. One of the most recent updates is integrated eco-profiling, which allows formulators to evaluate the environmental friendliness of their formulations using a method based on market and SPF benchmarking. It can be used with all UV filters on the market and factors in regulatory requirements in different parts of the world. top market UVA solutions, making it suitable for a wide range of applications. To illustrate the proficiency of this new product addition, DSM’s formulators have designed a ready-to-go Featherlight Cream SPF 50 guide formulation. Combining fast absorption and a silky touch with high protection into the blue light range, this formulation also comes with an eco-class A rating.

SUPPORTING CUSTOMERS’ INNOVATION EFFORTS Michele Marchini, head of marketing photoprotection, comments: “As a responsible, purpose-led company, we have an obligation to help consumers make informed, science-based decisions when it comes to their skin protection, as well as advance the search for new, more effective UV solutions. With the Parsol EHT launch we offer our customers a highperforming and sustainable product that will in turn allow them to deliver compelling products which consumers will enjoy applying regularly.” With Parsol EHT, available locally from Chempure, formulators can design eco-friendly sun care products that meet consumer demand in terms of their efficacy, sensorial benefits and eco-friendly aspects. •

T o B a

REFERENCES: 1. Sun Care products market size, shares & COVID-19 impact analysis, October 2020, Fortune Business Insights https://www.fortunebusinessinsights.com/ sun-care-products-market-103821 2. Sun Care Products Market 2020-2026, July 2021, Orion Market Research Private Limited https://www. researchandmarkets.com/reports/5406739/sun-careproducts-market-2020-2026?utm_source=BW&utm_ medium=PressRelease&utm_code=b57dw4&utm_ campaign=1585766+-+Global+Sun+Care+Products+ Market+Outlook+to+2026%3a+Online+Channels+Seg ment+Forecast+to+Hold+Lucrative+Market+Share&u tm_exec=cari18prd 3. A year of innovation in sun care, 2021, June 2021, Mintel

DSM – www.dsm.com Chempure – www.chempure.co.za

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

27


QA, QC, COMPLIANCE & TRAINING

Striving for continual improvement

The questions often asked are how are quality control and quality assurance related? How is GMP related to quality assurance? If we have quality control why do we need process validation? What other controls should we have in place to protect our processes? Peter Hannah, founder of Alec Cameron, explores the answers to these questions in a pharmaceutical context.

Q

uality control consists of sampling, testing and inspection. There are limitations with respect to quality control since we cannot test every gram or millilitre of the ingredients referred to as raw materials in pharmaceutical or cosmetic formulations. If we did we would require enormous resources of people and equipment and there would be nothing left to use for the manufacture of the product. As it is we take only a sample from our raw materials and test. We cannot test every tablet, or capsule of our pharmaceutical product or every millilitre of a cosmetic cream or gel. If we did we would have nothing left to sell. Quality control is really a misnomer in that we cannot control quality by testing alone. Let us consider the steps of a production process from beginning to the end. This involves: 1. purchasing raw materials and packaging components, referred to as starting materials

28

2. receiving starting materials 3. sampling raw materials 4. inspection of the packaging components 5. testing the samples of raw materials 6. planning of the production batches 7. dispensing the raw materials 8. manufacture of the bulk product 9. sampling and testing of the bulk product 10. packaging of the bulk product 11. in-process inspection during the packaging of the product 12. testing the bulk product 13. warehousing of the finished product 14. distribution of the finished product. 15. handling of any customer complaints. So what provides us with the confidence that our product meets its quality requirement? That is quality assurance, which has two major functions. Firstly, it seeks to protect the product and the end-user and secondly, protecting the company. Simply put, it is an assurance of quality. But what provides this confidence in the quality of the product? It is not just one thing,

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

but rather a number of things. Pretty much like a Reuben sandwich which is a sandwich that has a number of layers of fillings, such as ham, cheese, chicken etc. But our QA sandwich has different layers, including: • quality control • standard operating procedures • stability testing • training • validation of processes • qualification of instruments and equipment • good manufacturing practice (GMP) • good laboratory practice • auditing.

"It is imperative that we stay current with the guidelines and learn from the experts"


QA, QC, COMPLIANCE & TRAINING THE MULTIPLE AREAS OF GMP GMP may sound as if it is only concerned with manufacturing to good practice, but it is basically ensuring good practice in every aspect of the production process described previously – from the receipt of raw materials to the distribution of the product to the end user. You could consider GMP not only as good manufacturing practice but as GXP where the X stands for multiple i.e. good multiple practice involving good purchasing, receiving, warehousing, sampling, testing, planning, dispensing, manufacturing, packaging and distribution practices. We often refer to the four Ps in GMP. They are considered the pillars on which GMP is built and involve people, premises (equipment included), process, procedures (documentation included). Each of the Ps has a fundamental requirement, and in every step in the production process the

evidence that provides a high degree of assurance that a process will consistently meet pre-determined specifications and quality attribute”. In other words, every batch will – day after day and week after week – meet the specified outcome whether it be a tablet, a sterile, syrup or cream. Or be it a batch of purified water or a specific air cleanness or the cleaning of a vessel etc. How do we know that each tablet in a batch of 600 000 is identical in mass, assay, friability, dissolution, hardness? Quality control will give us that assurance. And since we cannot test every tablet, process validation will also give us the assurance.

four Ps are important. Consider the receiving area as an example: the receiving clerk is the people; the area the premises; the receiving function the process and the SOPs and record the procedures and documentation.

PEOPLE Are they committed to following good practice? Have they been properly trained? This includes on the job training as well as GMP specific to their function. Do they know what GMP requires of them. Job competency is currently being given a lot of attention by GMP auditors. One of the documents that are always reviewed is training records.

Are they suitable? Is there sufficient space for all the functions and systems involved? Is there sufficient utilities such as HVAC and purified water? Is the equipment suitable? Is there sufficient instrumentation? Have they instruments and equipment been qualified?

How do we know that every single bottle in a batch of 10 000 will each contain 100 tablets and every label will have a batch number and expiry date? In-process inspection would give us that assurance if we checked every single bottle but this would also be an expensive and time consuming task. Therefore we use validation of the packaging process to give us the assurance we need.

PROCESS

PROCEDURES

PREMISES

Are the processes under control, be it manufacturing processes or packaging processes or even processes such as the production of purified water, or of HVAC systems and even cleaning processes. GMP states that key steps in the processes must be monitored. The FDA definition of process validation makes it quite clear: “Validation is documented

SOPs must be available for every task required to be performed correctly every time. They must be available at the site where the activity is being performed and the person performing the task must be competent in following the SOP. SOPs are like a tool that we use to perform a task such as using a screwdriver to turn a screw. If the SOP is badly written then it

becomes a poor tool. Using our example, if the screwdriver was blunt it would not turn the screw. If the GMP is not well written, and the people are not competent in following the SOP, then the SOP has no value. This is why SOPs are often scrutinised by GMP auditors to ensure they are well written and the people are competent in following them.

THE IMPORTANCE OF TRAINING GMP is dynamic, it is always changing and the regulators demand that we follow the good practice. In fact the new buzz words are “strive for continual improvement”. The GMP guidelines, be they the PICS or EU or FDA, will openly admit that even if they are followed to the letter, they are only the minimum requirements i.e. the skeleton. The guidelines have improved in leaps and bounds over the last few years with quality management systems that include valueadding systems such as root cause analysis, CAPA, change control, annual product reviews, management reviews and quality risk management. It is imperative that we stay current with the guidelines and learn from the experts. It is imperative that we attend GMP training or good laboratory practice (often referred to as GMP in the laboratory), good warehouse wholesale distribution practice and indeed other refresher courses. There is no substitute for experience and that is why it is always better to attend courses presented by professional trainers who have the experience. Their knowledge not only ensures you are GMP guideline compliant, but also have guidance to add the muscle, tendons, nerve system, blood system, skin and hair to the GMP skeleton. •

ABOUT THE AUTHOR

Peter Hannah, founder of Alec Cameron, has been working in pharmaceutical quality management for a number of years. He has worked at Wellcome Pharmaceuticals, Abbott Laboratories and Adcock Ingram Pharmaceuticals before establishing Alec Cameron GMP Training in 1996. He has trained throughout South Africa and outside its borders as well as within the European pharmaceutical industry. His new online training platform has received fantastic reviews from the industry.

Alec Cameron – www.aleccameron.com

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

29


QA, QC, COMPLIANCE & TRAINING

The power of brand promise

built on quality control and assurance Product marketing is central to the success of cosmetics and personal care companies. Exploring new and innovative technologies to deliver to the ever-savvy consumer has become a necessity. Furthermore, the pandemic has resulted in consumers’ heightened awareness of the quality, safety and efficacy of products. Dershana Jackison, head of policy and regulatory affairs at CTFA, unpacks the distinct and separate roles of quality control and quality assurance and how both their functions are essential to cosmetics manufacturing.

I

n August 2020, Accenture reported on new consumer research, which the consultancy had been conducting fortnightly since March 2020. The data indicates that “habits formed during the crisis will endure well beyond it, permanently changing values, attitudes and behaviour”. Accenture also reported that 67% of consumers have “high expectations of medium and large businesses to act responsibly, supporting employees and addressing major social and environmental issues”.1 These studies provide a window into the pre-requisites for the future success of cosmetic brands. It begins with understanding the role of every tier of the product manufacturing value chain and how each tier ensures all products introduced to market are successful, safe and efficacious.

30

Did you know? CTFA offers a two-day intensive cosmetic GMP training programme for members of the cosmetics industry. Please send an email to info@ctfa.co.za for more information on the association’s training calendar for 2022.

The golden keys to unlock the delivery of consistent product quality without compromising on innovation and trends are quality control and quality assurance coupled with good manufacturing practices (GMP). Whilst quality control and quality assurance guarantee the quality and safety aspects of a product, GMP supports product safety during manufacturing, storage and despatch. At this juncture, it is necessary to mention that a product safety assessment is integral to the final safety assurance, however

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

for the purpose of this article only the mentioned processes will be discussed.

THE QUALITY MANAGEMENT SYSTEM The product value chain can be thought of as a series of activities, which form a process flow from ingredient and component sourcing to processing and final product packing and despatch. The framework within which this process occurs is defined by a quality management system, which includes specific controls, tests and standard operating procedures. ISO 9001:2015, published by the International Organisation for Standardisation (ISO), is an industry accepted international standard and excellent tool for the implementation of a quality management system that will enhance your value chain


QA, QC, COMPLIANCE & TRAINING

irrespective of the size of your business. It enables a company to: • demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements • enhance customer satisfaction through the effective application of the system, including processes for system improvements and the assurance of conformity to customer and applicable statutory and regulatory requirements. 2 On a broad and practical level, a quality management system guides the content of standard operating procedures, identification of critical control points and corrective and preventative decision-making. Ideally, the functions of quality control and quality assurance should be separate and these usually function as two separate departments within a company. Their roles are quite different and specific. The quality control department is responsible for testing while the quality assurance department functions in a policing capacity. It is also the quality assurance department that is responsible for the implementation of the quality management system and GMP.

water used to manufacture consumer products and specifications are determined as per the relevant Pharmacopeia. Quality control testing provides a snap-shot of quality compliance by virtue of physical, chemical and microbiological properties of the sample being tested. For this reason, it is important that samples taken for testing are representative of the batch and that sampling staff are adequately trained on the sampling process. Errors may potentially lead to false negative results or worse – such as contamination of the entire container or batch.

WHAT IS QUALITY ASSURANCE? Quality assurance (QA) is the process that involves the inspection of every tier of the value chain for compliance to specific and detailed standard operating procedures relevant to that process. This compliance assures the consistent quality of the product. These include receiving checks, in-process logs, cleaning and sanitisation records, quality control records, internal audit reports, corrective and preventative action records, customer complaint records, etc.

WHERE DOES GMP FIT IN? WHAT IS QUALITY CONTROL TESTING? Quality control testing functions to ensure that the material or product being tested meets pre-determined quality specifications. This includes the testing of incoming materials, in-process product, final bulk product and finished products. Adequately qualified and trained laboratory technicians are required to perform this function. Specifications can be obtained from suppliers and the research and development department responsible for product development. Quality control testing also extends to the testing of deionised

Just as consistent product quality is imperative to a brand’s success, product safety is a regulatory responsibility paramount to a brand’s reputation. ISO 22716:2017 Cosmetic Good Manufacturing Practices is an accepted international standard used by the cosmetics industry. According to ISO, it provides a guideline to the “production, control, storage and shipment of cosmetic products”. A company can implement the principles outlined in this standard to ensure product safety and as such proactively comply with the GMP requirement of the National

Department of Health’s draft Regulations relating to labelling, advertising and composition of cosmetics, R.1469, 22 December 2017. There are several key performance indicators (KPIs) to gauge the successful implementation of the standard. These indicators are also useful for tangibly realising your company’s return on investment in human resources and other costs for such an implementation. These include the rejection rate, non-conformance rate and number of customer complaints over a period of time. These KPIs can be monitored through internal audits carried out by QA staff. The finding of such an audit is two-fold. Firstly, it determines whether the implementation is successful and secondly, perhaps more importantly, it provides an opportunity for continuous improvement – the ultimate goal of every aspiring manufacturing facility. Companies can utilise the framework provided by the mentioned standards to address peripheral requirements that require integration into the product manufacturing process, such as environmental and social responsibility. Standard operating procedures can be developed to support the qualification of suppliers based on their commitments to these requirements. Another example is to include the company’s waste management programme in the standard operating procedures and to introduce controls to ensure successful implementation. • REFERENCES: 1. www.accenture.com/za-en/insights/retail/ coronavirus-consumer-habits 2. www.iso.org/standard/62085.html 3. www.iso.org/standard/36437.html

o6 Agencies – www.o6southafrica.com

"Just as consistent product quality is imperative to a brand’s success, product safety is a regulatory responsibility paramount to a brand’s reputation" Carst & Walker – www.carst.co.za Gattefossé – www.gattefosse.com

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

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FRAGRANCES & ESSENTIAL OILS

AI-powered olfactive social listening tool launched Givaudan has launched DigiPulse, the first olfactive social listening tool designed to collect and decode consumers’ spontaneous online comments about fine fragrances. Currently being used in France, DigiPulse will be launched in the US in the forthcoming months, followed by a global roll-out in 2022.

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owered by artificial intelligence (AI), DigiPulse collects the voices of consumers using a special algorithm, which captures and analyses their views with a unique focus on olfactory-driven perceptions. Givaudan perfumers and creative teams then use the decoded olfactive data to tailor their fragrance creations to consumers’ desires. DigiPulse categorises more than 2.5m online comments across a range of social networks. Its customisation allows Givaudan experts to analyse the data gathered to easily identify consumers’ olfactive perspectives and preferences. The data is transferred to the company’s creative teams to analyse the responses to traditional and established fine fragrances, as well as new launches. The most differentiating element of the tool is its ability to focus on the olfactive data, revealing insights on different aspects of the fragrance itself, on top of more obvious comments around packaging, marketing and advertising.

A TOOL TO ENRICH SCENT INNOVATION “DigiPulse is a digitally strategic way of capturing feedback from consumers’ online posts on their impressions of fragrances they’ve used or experimented with in their everyday lives. The new olfactive tool, which uses AI, will allow us to gather instant, unfiltered consumer feedback. Most importantly, it will enrich the way we craft perfumes, which will continue to inspire consumers around the world,” says Arnaud Guggenbuhl, head of global marketing insight and image, Givaudan. Givaudan’s latest olfactive social listening tool leads the industry in identifying the success of iconic and fresh new fragrances with information directly from the consumer experience. The intel will allow the company to integrate consumers’ immediate responses related to a fragrance or to specific

"DigiPulse categorises more than 2.5m online comments across a range of social networks" 32

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A CLOSER LOOK AT GIVAUDAN As a global leader in the creation of fragrances and flavours, Givaudan’s heritage stretches back over 250 years. The company has a long history of innovating scents and tastes, from a favourite drink to your daily meal; and prestige perfumes to cosmetics and laundry care. Givaudan’s creations inspire emotions and delight millions of consumers worldwide. The company is committed to driving purposeled, long-term growth while leading the way to improve happiness and health for people and nature. In the fiscal year 2020, Givaudan employed almost 16 000 people worldwide and achieved sales of 6.3bn Swiss francs and a free cash flow of 12.8% of sales. ingredients directly into the creation process, which is crucial for brand development and scent innovation. • Givaudan – www.givaudan.com


FRAGRANCES & ESSENTIAL OILS

SAEOPA contributes to first local essential oils standard Essential oil of geranium, from the South African hybrid pelargonium var rosé, now has an officially defined standard based on its unique chemical composition. SAEOPA has been instrumental in establishing the new SANS 4731:2021 standard. This is the first standard published in support of the local essentials oil industry, which ultimately helps South Africa be more competitive on the international essential oils market.

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he Southern African Essential Oil Producers’ Association (SAEOPA) was formed in 2000 by women and continues to be run mainly by motivated and dynamic women who work in the natural products industry. “We produce essential oils and vegetable oils for cosmetics, toiletries, perfumery, flavourings, aromatherapy and pharmaceutical applications. Women are involved along the complete value chain,” explains Karen Swanepoel, executive director of SAEOPA. The role players from SEAOPA who collaborated with SABS were mainly

highly motivated and skilled women, who worked together as a team.”

DEFINED BY DISTINCTIVE CHARACTERISTICS Geranium oil is heavily used in the perfume industry and in perfumed household products of all kinds, and rates as one of the most important essential oils. Much of that oil comes from plants cultivated in China and North Africa, where modern hybrids have been developed. According to the new SANS 4731:2021 standard, one can tell by both sight and smell if the rose geranium oil originates from South Africa.

A document released by SABS states that South African national standards, such as SANS 4731, aim to ensure that the unique features of a South African essential oil can be distinguished from other oils produced abroad. Local oils are dark green in colour in contrast to the yellowgreen associated with oils from other sources. The national standard aims to assist in distinguishing locally produced rose geranium oil, linking it to a country of origin. •

SAEOPA – www.saeopa.co.za

Tel 011 608 4944 Fax 011 608 4948 Email sales@sensetek.biz

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How to bring your fragrance

creations to life

Agile and focused, o6 Agencies continues to fuel the appetite for innovation among personal care and cosmetics manufacturers in Kenya and Tanzania. Both East African countries are of fundamental importance to the company, which supplies fragrances and flavours to customers of all sizes, including large-scale FMCG manufacturers, midsize producers of cosmetics and smaller entrepreneur-lead businesses. By Abby Vorster

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lthough o6 Agencies is based in South Africa, Richard Owen, who co-owns the company with his son, Adam, has been travelling to East Africa regularly for years, leveraging their on-the-ground presence to help customers develop new ideas and to fulfil requirements for trendsetting fragrance creations. The company has an unwavering ethos of customer service, which is supported by the team’s in-depth knowledge of consumer preferences in Kenya and Tanzania. It also has access to a network of resources, providing insights into global trends in the fragrance and personal care industries. According to Adam, a fine fragrance trickle-down continues to dominate the home care and air freshener segments in East Africa.

"Scented body mists have become an absolute must-have in East Africa" “Sophisticated fine fragrance directions are noticeable in body lotion, soap and shampoo creations, which feature enchanting scents of fresh florals and tropical fruity notes. Oriental florals are preferred for washing

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detergents – this scent preference also extends to some applications in personal care,” he explains. “Scented body mists have become an absolute musthave in East Africa since they made a comeback internationally in 2020. These light, refreshing and subtlyscented body sprays are not only affordable but also perfect for daytime wear.”

FRANGIPANI BECOMES A FIRM FAVOURITE Encouraged by the worldwide boom in self-care, Adam says frangipani fragrance oil is in high demand. Frangipanis are the beautiful fragrant tropical flowers of plumeria trees, and they are an iconic symbol of the spa industry. Comparable to the renowned scent of lily of the valley, frangipani fragrance oil has a strong, rich and luxurious floral fragrance with sweet and sophisticated accents. Notes of rose, ripe banana, grape, plum and lemon are unravelled in the fragrance oil, which is rounded off with a slightly spicy floral note. o6 Agencies’ frangipani fragrance oil is a high-quality essential oil replica obtained through chemical synthesis. It forms part

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of the company’s Nu Naturals portfolio of essential oil replicas, which function effectively as fragrance ingredients in soaps, body lotions, shampoos and hair conditioners etc. The Nu Naturals range is allergen-free, taking consumers’ skin sensitivity needs into consideration. The range also offers the added advantage of a reduced carbon footprint and avoids the high labour costs associated with the traditional fragrance oil extraction process. There is a diverse selection of notes in o6 Agencies’ basket of Nu Naturals, such as blood orange, lime, lemon and orange citrus oils; dragon fruit; lily of the valley and sweet jasmine.

SUSTAINABILITY TREND BECOMES A WAY OF LIFE As a forward-thinking business, o6 Agencies is inspired by the emerging trends around us, from fashion and architecture to art, cuisine and lifestyle products. Keeping an eye on these developments equips the company with vast creative knowledge and ideas to share with customers, ultimately enhancing their new product development (NPD). Adam points to the sustainability movement, saying it’s a trend that is here to stay. It is a major driver of NPD, with


FRAGRANCES & ESSENTIAL OILS

planet will succeed in winning over consumers who prioritise sustainability.

INCLUSIVITY IS UNAVOIDABLE

Did you know? Trend experts are saying that fragrance brands should push a narrative which aligns with hygiene and cleanliness. While new products should highlight creativity in perfumery, it’s also important to appeal to consumers’ increased focus on hygiene and disinfection brought about by the pandemic.

almost every brand owner wanting to incorporate elements of sustainability or the entire model in their NPD projects. The most obvious changes can be seen in ingredient sourcing and the processes used to manufacture goods. Brands can also reduce a product’s packaging or replace less sustainable packaging options such as laminates, foils and shrinksleeves with recyclable or bio-based materials. Consumers are openly and enthusiastically exploring new

sustainability concepts, with the aim of nature conservation and preservation. Mass consumption is shifting, making way for quality consumption where they only purchase products they genuinely need. This pursuit of holistic well-being empowers consumers to connect internally, with their roots and Mother Earth. These consumers will buy local products, source sustainable ingredients and prioritise local traditions, helping to rekindle a positive relationship between humans and nature. In the cosmetics industry, sustainability demands are seen in the increasing need to create clean beauty products that are transparent, actively preserve natural resources and respect the skin’s microbiome. Brands that create products which help consumers establish ties between their personal sense of well-being and that of a healthy

Looking further afield at the global fragrance industry, o6 Agencies underlines inclusivity, the multicultural angle, hygiene and cleanliness, as well as self-care as trends worth watching in the coming months. There is an opportunity for fragrance brands to be more inclusive in order to resonate with all consumers. If highprofile fragrance campaigns are actively portraying a multitude of identities, it’s time that smaller brands cottoned on to the trend as there is a great need for inclusivity at all levels of industry. This can and should be expressed more broadly with better representation of all racial groups, genders, sexual orientations, body types, ages and abilities. In the fragrance industry, refill claims remain niche, yet brands can no longer hide from increased eco-pressures that call for more sustainably packaged products produced using fully traceable and ethically-sourced ingredients. Floratropia fragrances are sold in flexible pouches to convey the brand’s eco merits. The brand promotes the reduced carbon footprint of the pouches in comparison to regular glass bottles. It also offers refillable travel sprays in faux leather cases. Expanded Carbon by Corps Volatils is a fine fragrance for men and women packaged in a refillable bottle made from recyclable aluminium and glass. The primary packaging is designed to protect the ingredients from light, while the exterior casing is made from recycled plastic. •

o6 Agencies – www.o6southafrica.com

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FRAGRANCES & ESSENTIAL OILS

Sustainable patchouli programme expanded to make a tangible difference

Symrise and Van Aroma are expanding their sustainable patchouli programme into Sumatra, the original Indonesian home of patchouli. The programme will grow the network for good agricultural practices in patchouli cultivation while enabling farmers to safeguard a fair income and ensure the sustainability of their businesses.

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oth parties have signed a memorandum of understanding (MOU) with PT. Sirukam Lumbung Nagari for the rejuvenation of cultivation in the region. This forms a further step of the programme launched by Symrise in 2017 in association with Van Aroma. It gives Sumatran farmers access to a growing network in the region which includes nearly 600 farmers in Sulawesi. “We feel excited to take this project to the next stage,” says Ramkumar Venkataraman, Symrise’s vice president of global sustainable sourcing, Scent and Care Division. “Our work in Sulawesi has helped farmers and communities to understand and assess the sustainable cultivation of patchouli and its value as a cash crop and important source of income. The programme’s success demonstrates the importance and benefit of regenerative agriculture in ensuring sustainability.”

MAKING A TANGIBLE DIFFERENCE The programme brings multiple benefits, including helping farmers to enjoy a fair income and enhanced business security. It also gives Symrise access to a reliable supply of high-quality sustainable patchouli oil and in turn, customers can source beautiful, responsibly sourced fragrance ingredients. The geographical expansion of the programme into Sumatra with Van Aroma adds further resilience to the supply chain. The programme can make a difference, because patchouli farmers face a range of challenges. They can address them by learning to better understand sustainable cultivation practices. For instance, patchouli tends to take nutrients from the soil fairly rapidly and plants can become infected with diseases, resulting in the destruction of crops and significantly

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INTRODUCING LILYBELLE BY SYMRISE The fragrances and flavours group has developed a special fragrance raw material from renewable sources. Lilybelle is a lily of the valley fragrance ingredient with a refreshingly flowery note. The raw material will provide perfumers with novel possibilities for the creation of scents for personal care products, cleaning products and laundry care products. Symrise manufactures Lilybelle using by-products from the orange juice industry, so that 83% of the raw material is composed from renewable ingredients. The product is also readily biodegradable. With Lilybelle, Symrise is expanding its portfolio of special fragrance ingredients to include a sustainable, readily biodegradable solution. It emphasises the flowery scent of lily of the valley in perfumes, providing ozonic green facets and lightly aqueous transparent accents. All in all, Lilybelle brings freshness and a certain lightness to fragrance creations. The scent of lily of the valley flowers has long played an important role in perfumery and is considered timeless due to its transparency, freshness and naturalness. It is used particularly often in men’s fragrances in combination with citrus notes. impacting the livelihood of the farmers. The programme shows a commitment to helping patchouli farming communities to cultivate the

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crop sustainably and cost-effectively, while generating the best quality patchouli oil.

USING TECHNOLOGY TO REACH FARMERS “We expect this collaboration to combine the vast expertise and knowledge of Symrise and Van Aroma with our understanding of local conditions and farming culture, and to bring sustainable cultivation of patchouli to West Sumatra,” says Budi Budar, owner of PT. Sirukam Lumbung Nagari. Sandeep Tekriwal, CEO of Van Aroma adds, “Sumatra patchouli oil has a very special woody sweet note found only in Sumatra. We must do something to help preserve this treasure for generations to come.” The programme aims to work with authorities and farming communities to promote the benefits of eco-friendly patchouli cultivation. The program also uses technology to reach and inform farmers. The Nilampedia digital agricultural communication and education tool, available through YouTube and FaceBook, has already attracted almost 6 000 users since its launch in 2020. The Komunitas Petani Nilam Facebook community for discussion and expert advice has nearly 2 000 members. •

Symrise – www.symrise.com Sumatran patchouli farmers are set to benefit from the expansion of the sustainable patchouli programme by Symrise and Van Aroma


PHARMACEUTICAL FOCUS

Marchesini Group expands into new technologies with latest acquisition A new ‘made in Italy’ mechanical company is joining Marchesini Group. Dott. Bonapace, based in Milan, manufactures laboratory machines for research and development applications and for small volume industrial production of consumables. Marchesini is a Bologna-based multinational that specialises in the production of industrial lines for pharmaceutical packaging, including COVID-19 vaccines and cosmetic products.

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ott. Bonapace has been in operation in several areas of the pharmaceutical industry for

75 years. In 1872, the present chairman’s grandfather started the business as a pharmacist. Thereafter, three Bonapace generations transformed the pharmacy focused business into supplier of solutions for the pharmaceutical industry which is capable of meeting the needs of over 5 000 customers worldwide, including ministries of health and stateowned enterprises in Marchesini Group CEO, many countries. Pietro Cassani Grown from the bottom up, the success story of Bonapace reflects the same passion and dedication of the Marchesini Group, which started out in a garage in Pianoro, Bologna. Over the course of 45 years, the group has become one of the world’s leading players in the packaging industry, with 2 000 employees and a turnover of €430m.

VENTURING INTO LABORATORY MACHINERY The acquisition will see Marchesini Group obtain 70% of the shares in Bonapace while expanding its already extensive machine park with new technologies that handle special products such as suppositories and capsules. “We have made a number of important acquisitions in recent years, but Dott. Bonapace is our first venture into the laboratory machinery market,” comments Marchesini Group CEO, Pietro Cassani.

"The acquisition will see Marchesini Group obtain 70% of the shares in Bonapac" “Entering this new segment – as was the case for the high-level software segment – will allow us to further diversify our portfolio of mechanical companies and better manage the supply chain during this current period of recovery.”

USING TECHNOLOGY TO REACH FARMERS Flavio Gallocchio, marketing manager at Bonapace, adds: “My partner Simone Berto and I are proud to inform customers, suppliers and employees

that our company has now become part of the prestigious Marchesini Group. We are therefore celebrating our 75th anniversary with the confidence that this collaboration will once again showcase Italian excellence worldwide.” The first promotion of the acquisition took place at CPhI Worldwide in Milan, Italy. The show ran from 9 to 11 November, marking the return of international trade shows dedicated to showcasing pharmaceutical technologies. For the occasion, Marchesini Group exhibited a BL-A418 CW Print&Check machine, which is designed to meet the needs of pharmaceutical product tracking for anti-counterfeiting purposes. Bonapace used the show as an opportunity to celebrate its 75th anniversary. • Dott. Bonapace – www.dottbonapace.it Marchesini Group – www.marchesini.com

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PHARMACEUTICAL FOCUS

Standardisation of multi-vial vaccine line speeds up delivery times Since the rollout of the global COVID-19 vaccination programme, there has been a massive demand for vaccine processing technologies. In addition to performance, quality and safety, rapid machine availability is a key concern. In response, Romaco has developed standardised solutions, such as the Promatic P 91 multi-vial vaccine line, which reduces delivery times from order entry to FAT, to a mere three months.

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he GMP-compliant Promatic P 91 line is specially designed for the packaging of 2R, 6R and 10R vials. It

can produce packs of six, 10, 20 or 40 with a maximum output of 40 packs per minute. Servo motors and electronic cams guarantee safe handling when packing the glass vials. Toothed belts are used instead of chains for low-vibration running and to keep the vaccine line maintenance costs to a minimum. The HMI is configured with various functions to speed up and visualise troubleshooting and fault clearance. Several monitoring systems simultaneously permit optimal process control. Furthermore, the balcony architecture and ergonomic layout of the machine ensure it is readily accessible and visible, simplifying format changes and eliminating the risk of cross-contamination.

TRANSPORT VIA VACUUM On the intermittent motion cartoner, the vials are first placed in so-called cardboard eco-trays and then they are packed in cartons together with a booklet. To transfer the vials and to open the eco-trays and cartons, the Promatic P 91

uses pick and place systems with vacuum grippers. It generates the required vacuum in a Venturi process rather than with classic

the pick and place system. The vacuum gripper positions the booklets on the loaded eco-trays before they are pushed into the cartons.

vacuum pumps. This has several advantages – as well as being comparatively small, Venturi pumps make less noise, give off less heat and generally need less maintenance.

Promatic cartoners like the P91 have a positive opening system that allows the eco-trays and cartons to be erected without being damaged. The packaging is pulled off and actively opened for this purpose by two vacuum grippers. Consequently, there is no friction that could impair the cartons. This makes the process ideal for recycled materials that have lower stability owing to their fibre structure, so gentle processing is a must.

"The compact transfer station ensures that all secondary packed vaccines can be tracked and traced reliably" The vaccine line is equipped with four different feeding units. Both the ecotrays and the cartons are fed via horizontal magazines. Vials originating from the rotary table are separated and grouped on a conveyor belt, and then inserted into the erected trays by Secondary packaged vials in eco-trays and cartons

RELIABLE TRACK AND TRACE The cartons pass through the Promatic carton carry immediately after exiting from the cartoner. The carton carry checks the hot glue closures and prints the Pharmacode – either a 2D data matrix or a QR code – on each pack. The compact transfer station ensures that all secondary packed vaccines can be tracked and traced reliably by verifying each code before the system releases the packs for the next process step. Romaco’s headquarters are located in Karlsruhe, Germany. It also operates from five European business sites with a broad portfolio consisting of seven established product brands. PMD Packaging is Romaco’s reseller and service agent in South Africa. • PMD Packaging – pmdpackaging.co.za Romaco – www.romaco.com

The Romaco Promatic P 91 intermittent motion multi-vial vaccine line for packing vials into eco-trays and cartons

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PHARMACEUTICAL FOCUS

New Lipex extruder enables fast and effective liposomal drug manufacturing Evonik has launched a new version of its industry renowned Lipex liposome extruder manufacturing equipment. Lipex Flow offers drug developers and manufacturers a superior device for bringing liposomal drug products to market.

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vailable worldwide since November 2021, the new device meets the need for more efficient, next-generation, high-pressure extruders to produce drug products requiring conventional liposomal drug delivery. These include active ingredients that

“Lipex Flow reinforces our position as a fullyintegrated system solutions provider to the pharmaceutical industry. It also complements our offering of products, technologies and services for complex parenterals,” says Paul Spencer, vice president drug delivery and

find application in oncology, vaccine, anti-fungal and anti-bacterial applications etc. Lipex Flow supports the scale-up of processes from drug discovery through to GMP at lab, pilot, intermediate and commercialscale volumes. Its launch also strengthens the portfolio of system solutions for advanced drug delivery at Evonik Health Care, which is part of the life sciences division Nutrition & Care. By 2030, Nutrition & Care aims to increase its share of system solutions from 20% to more than 50%.

medical device solutions at Evonik Health Care. “We look forward to seeing how Lipex Flow will provide an effective and versatile drug delivery platform for next-generation applications, spanning fields from oncology to vaccines.”

EFFECTIVE AND VERSATILE DRUG DELIVERY PLATFORM Lipex Flow is a next-generation extruder with a patent-pending design that maximises the effective filter area, resulting in lower extrusion pressures. Higher throughput, faster batch processing times and a broader operating range are also key advantages of the new design. The new extruder helps to minimise process risks such as contamination, product degradation and safety when working with highly-potent substances.

Did you know? Evonik also specialises in other equipment used in the production of liposomes, as well as polymeric microparticles, nanoparticles and implants. For example, it has extensive expertise in the use of microfluidics and micro mixing equipment to create homogeneous populations of liposomes via the controlled channelling of lipids dissolved in solvent and an aqueous buffer. This new, fast-growing process technology for liposome manufacturing is extrusion-free and scalable.

Lipex Flow offers higher throughput and faster batch production times for liposomal drug formulations

"Evonik’s platform of Lipex liposome extruders continue to set the industry standard for liposomal drug product manufacturing" Lipid-based particles, in particular conventional liposomes, provide a versatile and flexible drug delivery platform for several classes of active pharmaceutical ingredients (APIs), including small molecules, drug-lipid conjugates, proteins and peptides. Nearly 20 lipid-based drug products have already been approved by the FDA with many more in early and late clinical stages.

ENGINEERED FOR SEAMLESS SCALE-UP Evonik’s platform of Lipex liposome extruders continue to set the industry standard for liposomal drug product manufacturing. These extruders are widely used in the pharmaceutical and biotechnology industries to achieve a specified vesicle size in a reproducible and scalable one-step process. This process forces aqueous suspensions of lipids through the filters with a defined pore size. Unlike some alternative technologies, the relatively gentle pressures at controlled temperatures to

which the formulations are exposed ensure optimal particle size reduction, a homogenous population and high yield. As an integrated contract development and manufacturing organisation, Evonik Health Care is a leader in advanced drug delivery. It supports pharmaceutical companies worldwide in the development and production of complex parenteral drug products, which require an integrated offering of excipients, formulation technologies such as lipid nanoparticles, and clinical and commercial manufacturing. Evonik also supplies a range of its processing products in lab, pilot, intermediate and commercial-scale sizes to help customers facilitate an integrated scale-up process from drug discovery through to GMP production. •

Evonik Health Care – healthcare.evonik.com

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PHARMACEUTICAL FOCUS

Enabling efficient short-run printing in the pharma industry Organisations need to strive for efficiency as business objectives are becoming more complex and business processes more demanding. Print often plays a crucial role as an enabler. Independent print analyst Ralf Schlözer explores Xeikon’s production solutions to best manage the critical printing requirements of pharmaceutical re-importers.

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thriving group of businesses with distinctive and critical print requirements are pharma re-importers, also known as parallel traders. The parallel trade of products indicates that such trade takes place outside of or in parallel with the distribution network a pharma manufacturer has established for its products as a member state of the European Economic Area (EEA). Parallel trade benefits from price differences in EEA countries for identical products. They buy products at a lower price in one EEA country and then transport, repackage and resell them in markets with higher prices. The parallel trader has the responsibility to assure regulatory compliance, purchasing, transport, warehousing, insurance, repackaging, quality assurance and promotion. In addition to holding a manufacturing authorisation, companies need to comply with the relevant good distribution practices for the necessary repackaging.

Parallel trade is a lawful form of trade; however, it is highly regulated by the European Commission and recipient

products will be available and which markets are the most promising, so they need to react fast. Batch sizes vary a lot

states. It provides for more competition among pharma companies, can help solve shortages in the market and puts pressure on prices.

too, which can result in very short print runs. Batches down to 50 labels are no exception. At the same time the variety is high, with SKUs often numbering more than 3 000.

THE PRINT REQUIREMENTS Re-importers have the responsibility to provide statutory information for each pack of pharmaceuticals distributed. Accordingly, print plays a major role in the process. Because of the different languages on packages and products, a parallel trader needs to repack the product and add the necessary information as required by local laws. The trader also needs to keep track of shipments and make sure that the information added is correct. The nature of the business in parallel trade of pharmaceuticals is not only highly regulated, but also very time sensitive, and opportunity and demand driven. Traders cannot plan ahead which

Octane-CX300

Examples of digitally-printed labels

Did you know? Affordable Medicines Europe represents Europe’s licensed parallel distribution industry. According to the organisation, the annual turnover of the industry is €5.5bn. Affordable Medicines Europe represents more than 120 companies in 23 EU/EEA member states. These members account for approximately 80% of the total parallel import market volume in the EU/EEA.

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PHARMACEUTICAL FOCUS

the laser die-cutter and stores these on a server for access by the laser cutter. All processes are automated to take off the burden from prepress and operators and to ensure all jobs are handled correctly.

EFFECTIVE COLOUR MANAGEMENT

The mix of short and medium runs and a large number of products create a huge workload on managing print. Installations print as many as 380 individual jobs in a day. The number of labels per job

is able to connect to an ERP, which allows the company to track the drugs that it has re-imported and to generate the orders each day for the labels to be printed. With the help of software developers, Xeikon

also varies greatly – it can be hundreds or even thousands of labels, however, more often it is a small, even miniscule number of labels. Furthermore, there is great variety in size and shape because all kinds of pharmaceutical products from various producers are handled, resulting in another challenge in terms of finishing. In short, there are multiple critical functions a print solution needs to accomplish, including: • short and medium print runs • very short turnaround time • closed loop integration of finishing • occasionally complex label structures • compliance with good manufacturing practices and regulations for pharma printing • verification and documentation of all print • solutions suitable for companies not experienced in print.

can programme solutions that interface into the company’s ordering system and can create JDF job tickets and print files. At the same time the software arranges and assembles the jobs to make best use of the press format and the finishing setup, considering the delivery times as well. The print-relevant data is extracted from the ERP system and sent to Xeikon’s X-800 DFE. In a step-andrepeat process, the final imposition is

SETTING UP AN EFFICIENT SOLUTION To operate cost-efficiently, a pharma re-importer needs a highly-sophisticated production solution in which print, converting and inspection are handled digitally and processes are kicked off automatically to save time and labour. Yet, the company’s main line of business is not in print. Accordingly, setting up an efficient print solution requires a consultative approach as provided by Xeikon and its Solution Services (XSS). An efficient production flow starts far upstream from the Xeikon full-colour digital press. The front-end of the press

"Setting up an efficient print solution requires a consultative approach" created and variable data is added to the labels as required. The very low volumes require printing in multiple lanes, to take advantage of the productivity and width of the Xeikon press and to make further processing efficient. This optimisation is done by the Varilane software on the DFE. In addition, the DFE creates a specified order ID and places data matrix codes at the beginning and end of each job in a lane. Those are used for an automated set-up of the finishing and verification equipment, allowing a flow with minimal or no human interaction and constant tracking. Finally, Xeikon’s Vectorizer software creates die-cut outline files for

The Xeikon presses are scalable to handle the high volume of small to mid-sized jobs effortlessly. Colour management can be automated as well, even a spot colour can be added in a fifth print station if required. Xeikon offers its Xeikon Color Services to support customers in achieving predictability and repeatability for brand colours and to match reference colours. This is crucial in pharma print where matching brand colours gives consumers confidence in a product. Various software tools, training and audits are available and can be customised for established printers and print newcomers to achieve accurate and reliable colour reproduction. At the end of the press, the rolls are slit to improve handling. Those rolls are loaded by the operator into one or multiple laser die-cutters. Using a laser die-cutter proved to be the most efficient and automated solution to create labels from the rolls of print. The laser die-cutter reads the data matrix code at the start of each job in each lane to automatically upload the correct die-cut files. The laser cutter is able to change dynamically the shapes of the labels on the web, and even across different lanes. The die-cutter also slits the web into final rolls according to the lanes. More complex designs can require the use of a dual laser die-cutter. For labels with windows the window portion is cut out with the first laser cutter unit and a clear laminate is applied. In the second laser die-cutter unit the outline of the label is cut. Based on an analysis of the label requirements, Xeikon Solution Services can set up these more complicated solutions as well. As a last step an inspection rewinder is used to verify that all processes have been performed correctly. The system checks for print, cutting and substrate defects. Again, with the data matrix codes printed at the start and end of each job, the job specifications can be retrieved by the inspection system automatically. The complete verification trail is a prerequisite for pharma printing. Based on the inspection system, Xeikon

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PHARMACEUTICAL FOCUS

can also implement automated reprint of orders or trigger waste ejection in label application lines.

THE BENEFITS OF DIGITAL PRINTING Digital print has been a great benefit to parallel traders. In many cases labels were sourced previously from thirdparty printing companies, printed on flexo presses. The short runs required high numbers of plates, start-up waste and set-up times, making the process inefficient and slow. Waste can be considerable with several hundred metres of substrate needed per changeover on a flexo web press. With the short runs typically required, the digital solution saves substrates by the factor of five. Necessary variable information (e.g., use-by dates, tracking codes, batch numbers) can be included in one

"The Xeikon presses are scalable to handle the high volume of small to mid-sized jobs effortlessly" go as well. Depending on the user’s requirements, Xeikon offers a range of security and anti-counterfeit features that can be added. As the system is fully digital, shortest runs down to a copy of one are possible, allowing for zero inventory for the traders – a further keystone in avoiding waste and costs. When moving to a zero-inventory solution, the space requirements for the complete production line on site are low. The whole line typically fits into the main company’s buildings. Xeikon set up its XSS group to identify and assemble the most efficient solution for customers requiring more than the standard equipment. This includes looking at the whole product and business workflow. XSS employs specialists who can draw from internal resources as well as procure external equipment or services. Accordingly, XSS is able to analyse the customer’s needs to identify and assemble the

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Laser die-cutter unit

best third-party equipment, software, competencies and consumables. The result is a turnkey solution for the customer. This is especially helpful for users which have not produced their own print before. The high reliability of Xeikon’s print systems further adds to the ease of use. Already more than 10 installations with pharma traders exemplify that these inhouse solutions offer a distinctive benefit for users to upgrade their equipment and insource print. The tight integration of print in business processes while keeping the print lines manageable leads to more pharma companies looking into insourcing of print.

AN EXAMPLE FOR OTHER INDUSTRIES There are many print applications and print service providers that can benefit from digital print manufacturing solutions designed by XSS, as the example for parallel traders in pharma shows. The integration of the DFE with the customer’s ERP system and in turn the integration of the DFE with finishing allows for efficient production. It also allows for complete control of the process. The installations demonstrate that Xeikon presses are designed to provide high-volume printing of short runs and even variable data – which can be useful for any in-house print production. With a portfolio of toner and inkjet-based devices, Xeikon can cater for a wide range of requirements.

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA

XSS does not only offer a consultative approach, Xeikon also takes responsibility of the whole installation, including services and consumables. The user benefits from having only one company to contact to set up the installation and keep it running. A last lesson is that Xeikon can install complex production lines even for sites with limited background in print. By taking ownership of the whole production line and delivering a turnkey solution, Xeikon can take digital print manufacturing into all kinds of environments requiring print. Rather than buying a printing press, users buy a solution which enables achieving the business objectives in terms of speed to market and handling an increasing diversity in jobs, at the right cost. •

ABOUT THE AUTHOR

Ralf Schlözer has over 30 years’ experience in the graphic arts and graphic system manufacturing industries. He is a freelance consultant and technology analyst for the printing industry with a special focus on digital print. Schlözer provides insights on technologies, applications, business models and market development. He is also an expert on market sizing and statistical sources around the printing industry.

Xeikon – www.xeikon.com/en


PHARMACEUTICAL FOCUS

Sustainable paper alternative for blister packaging Together with the packaging material manufacturer Huhtamaki, Syntegon has developed an innovative paper-based blister packaging solution. The packaging is likely to appeal to the health- and environmentally-conscious customer in terms of its feel and appearance.

E

arlier this year, the German Packaging Institute honoured Syntegon with the German Packaging Award in the category Sustainability for its ‘blister meets paper’ innovation. The jury was impressed by the sustainability and good functionality of the paper-based packaging solution. “While eco-friendly and health-conscious customers can already find sustainable packaging solutions for a wide range of products, an environmentally-friendly alternative for push-through packaging for tablets and capsules was not available prior to the launch of our solution. This is something that we wanted to change with blister meets paper,” says Torsten Sauer, sustainability project manager at Syntegon. The paper-based blisters are particularly suitable for nutraceuticals. In the version submitted for the awards, each blister has seven cavities for one tablet per weekday.

SUSTAINABLE AND SAFE While paper-based packaging offers advantages in terms of sustainability, it requires additional barrier layers to adequately protect the product without compromising recyclability. In addition, the tablets and capsules have to be pushed out of the blisters without being damaged. “This challenge addresses both the material and geometry of the packaging,” explains Matthias Klauser, sustainability expert at Syntegon. “Thanks to the combination of our TPU 1000 form, fill and seal machine for paper packaging, the 3D formable FibreForm paper from BillerudKorsnäs and the sealable barrier coating from Huhtamaki, we have succeeded in forming paper with the geometry required for tablets in cavities of 3mm to 4mm millimetres.” In the future, the paper blisters will also be available with diameters of 6mm to 10mm, to package larger tablets such as pain killers.

Did you know? The German Packaging Institute has been honouring recipients with the German Packaging Award since 1963. The international competition is hosted annually and is said to be the most important European showcase of achievements in the packaging industry. An independent jury evaluates the best innovations and solutions in a total of 10 categories. Sustainability was one of this year’s focal points.

COMPARABLE BARRIER PROPERTIES Packaging material expert, Huhtamaki used the same sealable barrier coating for the blister’s lidding material as in the base material and finished it with a special process to facilitate pushing the tablet through the material with ease. The environmentally-friendly material concept consisting of a thermoformable base film and a push-through lidding film with barrier coating is marketed as Huhtamaki push tab paper. The thermoformable barrier and seal layer is also heat-sealable, which makes the paper blister packaging’s barrier properties comparable to classic blister packaging made of mono-PVC or aluminium. “At the same time, we never lost sight of the sustainability aspect: both the base and lidding material can be recycled,” Sauer emphasizes.

EYE-CATCHING AT THE POINT OF SALE Blister meets paper attracts attention at the point of sale – not only due to the sustainable material, but also because of its numerous design options. The paper blisters can be printed on both sides, while an embossed brand logo can be applied to the top. A Euro hole can be punched in the upper area of the blister, which saves large quantities of packaging material

Tablets and capsules can be easily pressed through the blister’s cover material and removed

Blister meets paper from Syntegon and Huhtamaki won this year’s German Packaging Award in the Sustainability category

Syntegon’s TPU, in combination with BillerudKorsnäs’ 3D-formable FibreForm paper, allows for fine embossing and tablet cup forming, while Huhtamaki’s sealable barrier coating provides the necessary product protection

compared to conventional blisters in folding cartons. “This offers many opportunities for a successful product presentation and emphasises the environmental friendliness of the product. Manufacturers can also add Braille to the blisters or print a QR code for further information. The latter saves on the package insert and the cardboard outer packaging,” Sauer explains. “The result is a sophisticated all-round packaging concept for nutraceuticals which supports customers in taking care of both their health and the environment.” • Huhtamaki – www.huhtamaki.com Syntegon – www.syntegon.com

WWW.PHARMACOS.CO.ZA // NOVEMBER/DECEMBER 2021

43


Tea

time Take a breather

>>> QUIZ

Answers: Fact, Fiction, Fiction, Fiction, Fact, Fiction, Fiction, Fiction, Fiction, Fact, Fiction, Fact

Pop Culture Quiz – Fact or Fiction? 1. The Slinky toy was invented more than 50 years ago. 2. There were eight Marx Brothers, of movie fame. 3. The word “muppet” comes from a blend of “man” and “puppet.” 4. The Wizard of Oz used real cyclones, not special effects. 5. The Beatles were the first pop musicians to be awarded the MBE. 6. The inventor of Batman also created Superman. 7. The film version of the novel Devdas was directed by Jackie Chan. 8. Al-Jazeera is an Arabian bank. 9. Darth Vader was Luke Skywalker’s uncle. 10. Penelope Cruz is from Spain. 11. Daniel Craig starred in James Bond films, beginning with “Skyfall”. 12. American actress Amy Adams was born in Italy.

contact

To advertise in Anita Raath

Carla Melless

Sales executive

Sales executive

+27 (0)82 976 6541

+27 (0)83 260 6060

www.pharmacos.co.za

Càndida Giambò-Kruger Sales executive

+27 (0)71 438 1918

ADVERTISERS' INDEX CJP Chemicals ......................................IFC........www.cjpchemicals.co.za

Savannah Fine Chemicals.................25........www.savannah.co.za

Evonik Africa .........................................21........www.evonik.com/ceramides-decoded

Sensetek .................................................33........www.sensetek.co.za

Kimberly-Clark SA ................................. 7........https://home.kcprofessional.com/sa/

Teqal Creative Packaging...............OFC........www.teqal.co.za

hygiene-resources Moco Packaging ............................... OBC........www.mocopack.co.za

44

NOVEMBER/DECEMBER 2021 // WWW.PHARMACOS.CO.ZA


ONLINE

INDUSTRY WEB REVIEW ESSENTIAL SPECIALISED PRODUCTS

COSCHEM

Supplier of cosmetic and personal care ingredients.

Visitors to the Society of Cosmetic Chemists’ website will find information on membership, educational programmes (specific details pertaining to the Cosmetic Science Training), as well as the society’s objectives of promoting professionalism and higher technical skills in the personal care industry.

Ingredients include; Bioferments, Botanical Extracts, Delivery Systems, Enzymes, Functional Actives, Silicones, Emollients, Emulsifiers, Meadowfoam Seed Oil & Derivatives, Abyssinian and other Oils, Shea and other Butters, Aliphatic Hydrocarbons, Lanolin & Derivatives

www.coschem.co.za

Tel: 010 595 9690 Email: info@esp-sa.co.za www.esp-sa.co.za

M&L LABORATORY

DALGEN

M&L Laboratory Services (Pty) Ltd, provides clients with an extensive array of

Dalgen is a leading supplier of high-quality glass containers, plastic containers,

analytical capabilities. M&L renders testing services to the Food & Beverage,

closures and packaging accessories.

Mining, Environmental, Water & Pharmaceutical sectors. M&L is an ISO 17025

Tel +27 (0)31 569 4288 Fax +27 (0)31 569 4294 Email sales@dalgen.co.za or purchasing@dalgen.co.za www.dalgen.co.za

accredited facility, licenced by the Medicine Control Council (MCC) & endorsed by the World Health Organisation (WHO). Our schedule of accreditation can be viewed via www.sanas.co.za Phone: +27 (0) 11 661 7914 Cell: +27 (0) 81 399 9737 E-mail: peter.moopeloa@bureauveritas.com

BOTANICHEM

FORMPAK For over 50 years Formpak has supplied specialised processing, packaging and printing machinery to the pharmaceutical, cosmetic, plastic, glass, chemical,

BOTANICHEM is a supplier of specialist ingredients to the cosmetic and personal care industry, with a particular focus on plant-derived ingredients which support sustainable supply and fair-trade practice. We also aim to understand the needs of clients and to source the

food and dairy industries.

appropriate ingredient, at the right price.

Tel: +27 (0) 11 828 8870/1/2 Fax: +27 (0) 11 828 8880

www.botanichem.co.za

email: haase@formpak.com or service@formpak.com www.formpak.com

H&R AFRICA Your world's leading supplier of top quality mineral oils, petroleum jellies, and paraffin waxes, as well as customer-specific formulations. If you want to come out top you have to partner with the world's top leaders. Connect with us to see how we can connect your business to the world.

113 Trinidad Road, Island View Bluff, Durban 4052, South Africa Tel: +2731 466 8700 Fax: +2731 466 8716/7 Email: sasales@hur.com Website: www.hur.com

QUANTUM COLOURS SA Your No. 1 industry leader for the most comprehensive ranges of both synthetic and natural colours – used in food, pharmaceutical, cosmetic and industrial applications. Tablet coatings – manufactured, supplied and marketed globally under our trade name PHARMASPEC™ - FC

www.quantumcolours.com Manufactured, marketed and distributed under licence of SPECTRATEC INC. CANADA

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