Packaging In Focus - July 2021 - Pharma

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Opinionated about packaging

TRENDS

Technology & Innovation

THE SUSTAINABLE

packaging challenge

SMART

pharma labels

The Pharma Edition

Accelerating the degradability of plastics

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FEATURES EDITOR’S LETTER

The pharmaceutical market has been under tremendous pressure over the past few years. First up, there were the many challenges caused by Brexit and also the increasingly tighter regulation of the market to battle counterfeiting of medicines. Then came the COVID-19 pandemic with astronomical amounts of labels and packaging needed for the millions (or is it now billions?) of testing kits and vaccines. Throw in the pressures from consumers to deliver ever more sustainable packaging solutions, and the industry push to implement new intelligent technologies – I think it’s safe to say that everyone involved has been very, very busy. In other words, we were not short of topics to cover in this issue of Packaging In Focus. Our aim is to shine a light on the latest trends and technologies, and we hope you will walk away with a good overview of what is driving innovation in the pharma sector. Neel Madsen, Guest Editor

TRENDS

4. 6. 38. 41.

Pharma: Trends you need to know about Looking over the counter Reducing waste and errors Adapting to new trends in outsourcing

SPOTLIGHT ON DESIGN

8. 24.

Revitalising vitamin branding Designing sustainable packaging

12. 17. 21. 26. 28. 30. 33. 37. 44.

Communicating with smart packaging

Digitising the supply chain LCAs: Finding the right balance Making pharma packaging sustainable UDIs: New system comes into force Healthcare barcodes for a digital future Labelling for pharma Sustainable packaging challenge Ready for all eventualities

FOCUS ON

18. 14. 22. 40.

HSM: Baling waste for recycling

Denny Bros: The specialist solutions expert Natupharma: Fast degrading plastic pots Nulogy: Solving shop floor problems


Trends you need to know about By Paul Jenkins, Managing Director, ThePackHub

The pharma and healthcare industry continues to deliver many new packaging innovations despite the turmoil of the pandemic. OVID-19 has created disruption, uncertainty and change for all involved in the pharma and healthcare packaging industry. The global pandemic has undoubtedly impacted every part of the packaging supply chain with consumers changing their shopping behaviour, as we experienced an increased shift to e-commerce channels. Despite this turmoil, improving sustainability in pharma and healthcare packaging continues to be of significant focus and is a substantial part of the packaging trends coming through the pipeline. Most brands, retailers and packaging suppliers are working on stretching targets as part of the UK Plastic Pact to achieve 100% recyclable, reusable or compostable packaging by 2025. With just over four years to go, the pace of change is accelerating despite the disruptions mentioned above. In addition, pending plastic tax obligations due for implementation in April next year encourage plastic packaging

4.

use with at least 30% recycled content. This is having an impact on the types of pharma and healthcare innovations that are being developed. However, the initiatives are not all focused on the environment. Finding alternatives to plastic Reducing the impact of plastic is showing little sign of slowing down. Both plastic reduction and elimination have been strong themes for pharma and healthcare packaging, as they have across all categories. Switching out of plastic can be difficult for operators due to its inexpensive nature, its versatility and practicality. It offers security and protection in the pharma sector as well. An example of this is from Tikkun Olam Makers (also known as TOM), which has designed a board-based

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alternative to plastic that fulfils FDA guidelines for water and light barriers, and also as important, child resistance. The child-proof design works through the lid that has tabs that clip into the main body of the container, which can then only be opened by squeezing the pack in pre-defined areas. Once the packs are empty, they can be disposed of alongside the biodegradable label in conventional composting. Another example in this area is from an Australian start-up, which has developed a paper-based alternative to replace plastic for pharmaceutical blister packs. The paper is derived from plant waste. Varden has introduced the new solution called Paperseal and received funding from Horizon Ventures to accelerate expansion. A bespoke machine has been


designed that gets around the challenges of forming 3D shapes using paper. Recyclable solutions Recycling initiatives will continue to gain traction. With the majority of brands and retailers working towards targets to improve the recyclability of their packaging, we are inevitably seeing many new initiatives come to market. Recycling is multi-faceted. It is the introduction of recyclable solutions – either through the switching from other materials or making the material easier to recycle (through the introduction of mono materials for example). It is also about the introduction of recycled content in packaging. Vericool is the inventor of the world’s first recyclable/ biodegradable cooler. The business has adapted its expertise to develop a sustainable thermal solution for shipping COVID-19 vaccines. The initiative is both recyclable and compostable. The shipping solution will eliminate the potential need for millions of unrecyclable EPS coolers during the global rollout of vaccines. Another recyclable initiative

has been introduced by Amcor. The blister pack has been a significant and well-established format for the safe packaging of pharmaceutical products for many years. However, the format has traditionally been difficult to recycle. Amcor has developed a new solution to combat this. Amsky is a recent initiative that has the potential to make healthcare packaging much more sustainable. It removes PVC (Polyvinyl chloride) from blister packaging, allowing it to be recycled more easily. Smarter packaging Intelligent packaging is making strides. Although both the environment and sustainability is very much the primary focus for pharma and healthcare brands, there are still requirements unique to this sector coming through the innovation pipeline. Smart packaging is being used increasingly often to track and trace items, especially those of high value. Avery Dennison has collaborated with US supply chain specialists SUKU and Swiss chip maker EM Electronic to create a new smart technology method of tracing products and goods

through the supply chain. Avery Dennison Smartrac’s RAINFC Belt DF tags based on EM Microelectronic’s em|echo-V IC (integrated circuit) allow for products to be traced through the innovative use of long-range, dual-frequency transponders, which accurately identify products and their condition.

Another example is from Woonsocket, Rhode Islandheadquartered pharmacy chain CVS Pharmacy with nearly 10,000 outlets across the US. The business has developed a new feature for its already-established consumer app to help the visually-impaired understand important information on packaging. A new RFID label will enable prescription details to be heard through the app, allowing patients with visual impairments and those who cannot read standard print labels to get vital product information. Spoken Rx is the first in-app prescription reader application to be developed by a national retail pharmacy. The first stage rollout will see 1,500 CVS Pharmacy outlets prepared to fix the RFID labels to prescription vials. Sustainability will continue to be the focus for the second half of 2021 and beyond as operators continue to implement their stretching environmentallyfocused targets.

5. Image: Vericool


Looking over the counter By Carmen Bryan, Consumer Analyst at GlobalData

Unlike prescribed medicines, overthe-counter products require a wider margin of safety in formulation and design to ensure safe, effective and responsible use. hether it is clear guidance labelling or tamper-proof features, over-the-counter (OTC) manufacturers must ensure that their products are accessible and safe for a wide consumer base within their home space.. Recently, the industry has seen a resurgence in demand for single-use products that prioritise sterilised and secure features. Matrixx Initiatives’ nasal cleansing swabs, which are sold under the Zicam Nasal AllClear brand, is tamper proof ensuring it remains sterile and safe to use until opened. The brand also emphasises its easy application for on-the-go. GlobalData’s week 11 2020 COVID-19 tracker reveals how prevalent security and safety concerns have become in relation to consumers’ purchasing behaviours. As of December 2020, 17% global consumers agree that sealed or tamper-proof packaging is their top priority as a direct result of the pandemic, while a further 34% stated that it is now slightly or significantly more important to them. The COVID-19 pandemic has led to a spike in demand for health and nutrition products that help consumers to safeguard their wellbeing during these uncertain times. As hospitals and clinics largely closed during lockdowns – open only for emergency cases – a window opened for OTC and healthcare products to provide simple and effective self-administer solutions that support consumers daily needs and growing anxieties around immunity and wellbeing. Bayer has recognised this with its launch of a Consumer Health division in India. The company plans to use digital technology innovations to help promote self-care and expand access to everyday health solutions to consumers. This is a well-timed step that shows the company’s commitment to addressing emerging consumer trends. In general, the incorporation of digitalisation in packaging is growing, as it enables manufacturers to easily utilise innovations such as QR codes to provide personalised services, accessible how-to guides and videos, and additional information on ingredients and production.

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On the other hand, the pandemic has had a two-fold impact on sustainability trends in OTC. Historically, environmentally friendly packaging is not highly prevalent in this market, taking a back seat to more pervasive concerns such as security, safety and accessibility. As such, you will still find plastic and film pack materials, whereas in other sectors such as food and beverage, there is a monumental shift towards more green packaging materials.

Image: Shutterstock

The pervasive usage of single-use plastics over the pandemic period has heightened consumer concern and directed attention to the OTC market. GlobalData’s research has found that environmentally friendly packaging claims have a positive influence on 78% of global consumers, with 34% of these agreeing that it is a key feature they look for in their choice of product. Combine this with increasing pressure from governments to go green, and we are likely to see more environmentally friendly materials being introduced in the coming years. GSK Consumer Healthcare, for instance, has launched a new initiative to reduce the plastic used in its Advil bottles by 20%, with expectations for this to be achieved by 2022. OTC and healthcare products are still behind in terms of sustainable packaging compared to other consumer sectors, as the industry must always prioritise safe, sterilised and accessible features. That said, the industry is moving toward a more sustainable position, and manufacturers should look to packaging innovations with green credentials that also uphold the accessible and sterile appeal.

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Revitalising vitamin branding By Amber Barrow, Account Director, Free The Birds

Design agency Free The Birds has created a new elevated look for Europe’s number one vitamin brand. upradyn is the number one VMS (vitamins, minerals and supplements) brand in Europe and one of the biggest names in the Bayer Consumer Health portfolio. Established in 1959, the packaging design had become dated over time and was no longer communicating the efficacy consumers had come to expect. The brand’s current architecture was particularly hard for consumers to navigate. Tasked with revitalising the design, Free The Birds created a simplified architecture and navigable creative system that united the design across all markets. While we needed a global design approach, within the healthcare sector it is always important to consider the individual regulatory challenges that each market faces. We wanted to enable the brand to flex per market as needed, while retaining a strong and consistent overarching global design framework. The biggest challenge was how to modernise and really move the brand forward, whilst retaining the existing brandmark. It was important that the logo was still easily recognisable on shelf.

The new design was brought to life through a refreshed brand logo and engaging ownable brand assets that come to life off-pack. The new logo retains the circular cues; however, the graphic communicates a stronger sense of energy and movement, and the wordmark is hero-ed and proud, breaking through the circular holding shape. Whilst we ultimately reduced the amount of yellow on pack, we were able to create a stronger brand presence with the efficacious power button, positioning the brand yellow at the top of each pack to create a consistent brand block. This also allowed more real estate space for the background colour, enabling us to make the most of the pillar navigation on pack and to introduce graphic patterns to further support differentiation between the core adult and kids ranges. There was also the perfect opportunity to further elevate the kids products through the creation of our new playful superhero characters, enabling the brand to utilise these assets to engage with kids on pack and digitally, through the brands website, and future campaigns. What has launched is a bright and confident rebrand that has a clearly defined brand design system that can be flexed as Supradyn continues on its future growth journey.

There were particular brand elements that were not to be touched. First and foremost, the Supradyn Yellow as the key brand identifier had to remain, as it was important that this primary colour association was not lost by consumers. Core to the Supradyn proposition are the three benefit pillars – our task was to better differentiate between these pillars to aid consumer selection.

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Reliable production support and fully automatic waste disposal By HSM

WP Packaging is part of GWP Group Ltd, one of the leading and most versatile providers of packaging solutions in Great Britain. Customer specific product and transport packaging made of corrugated cardboard is developed and produced in its sphere of business. Innovative thinking is the central factor behind the work of the packaging specialist from Cricklade, Wiltshire. The most recent investments for the future include an HSM VK 4208 channel baling press from HSM, which fully automatically compresses and bales the waste die cut pieces ready for recycling. GWP was originally founded in 1990 as The Great Western Packaging Company. The company has now grown to become a key player on the British packaging market and combines, under the umbrella of GWP Group Ltd, the five divisions of GWP Packaging, GWP Protective, GWP Correx, GWP Conductive and GWP Coatings.

Pedley, Operations Manager of the division, explains, “Our task is to design packaging solutions which perfectly showcase the packaged good at the point of sale and protect it from transport damage. The main priorities in the process are cost-efficiency and environmental compatibility.” Priorities which are reflected in the sophisticated corporate processes at GWP Packaging. Taking production as an example: Die cutting machines play a central role in the automated production process. They die cut cardboard sheets by means of

GWP Packaging serves customers from the beverages and foodstuffs, medical, automotive and IT and electronics sectors with packaging made of corrugated cardboard, which in terms of design and characteristics is tailored specifically to the product and its application. James

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cutting, punching and grooving into finished die cut cartons and fitments. “We design the punching dies so as to save as much material as possible and so that only small amounts of punchings, edge cuts for example, accumulate. We then return these to the recycling loop ,” explains James Pedley. Since October 2013, this has been achieved with the fully automatic support of the HSM VK 4208 channel baling press from HSM. It replaces a long-serving baling press that could no longer live up to the modern production concept or the increased safety requirements. Operating efficiency from production to disposal The new HSM VK 4208 has been integrated into the production process and operates by means of air feeding. The waste which occurs at several die cutting machines is extracted by suction while production is ongoing and taken directly to the channel


Sponsored feature baling press to be shredded with blade ventilators into corrugated cardboard remnants.

speak. If it is full, a light beam triggers a horizontal pressing process.

According to James Pedley, the reliability of the press has an effect on the efficiency of the entire process. “If it fails, production comes to a standstill for us, so we cannot afford to compromise on technical quality.”

The collected material is compacted into bales with a specific pressing power of 75 newtons per square metre and is then strapped automatically with wire. The bales weigh up to 420 kilograms. At GWP Packaging they are on average twice as heavy as they were with the old machine. This bale density and weight also impresses the recycling companies: they pay more than they did before for the recyclable waste die cut pieces – around 450 tons every year.

The Operations Manager regards the fully automatic operation of the HSM VK 4208 as another benefit. Where before he had to assign a man full time to operate it, the new channel baling press operates independently, so to

The brief was perfectly respected, and the solutions presented were of high quality. The very detailed projects revealed both highly technical aspects and interesting marketing concepts that could be retained by certain brands looking for new ideas.

Professionalism from advice to maintenance GWP Packaging didn’t opt for HSM just like that. James Pedley took time to become acquainted with various suppliers across Europe and to compare technical options. Right from the start he was impressed by the professionalism of the advice from HSM as well as the flexibility with which the company could handle customer requirements. The performance and workmanship of the machines were the factors which finally convinced him. “You look at the HSM presses and you can literally see their high quality.”

The delivery of the channel baling press in October 2013 confirmed his positive assessment: the narrow time window of a weekend was all that was available for the dismantling of the old machine and the commissioning of the new machine in a difficult to access area. But everything went

smoothly thanks to the excellent collaboration between those involved. The factory’s operations could continue uninterrupted. “I thought highly of HSM for that”, says Pedley, “and also for the willingness to allow our internal maintenance team itself to carry our preventive maintenance on the press. We would not have been able to achieve this ourselves and only worked because the training in the technology provided by the HSM team was also exemplary.”

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Communication through smart packaging By Christopher Waterhouse, Managing Director, iDi Pac Ltd

New technologies can be used to influence patient behaviour, improve communications and adherence to medication regimes resulting in improved outcomes. he largest single therapeutic area and issue facing the pharmaceutical industry is regimen treatment adherence and product communications. It is a widely held belief that much of this issue can be addressed through use of innovative and cost-effective packaging solutions. The pharmaceutical industry knows that on average only 50% of prescribed prescription drugs are consumed as required. It follows therefore that there may be a potential doubling of industry sales annually, currently estimated at around US$ 1 trillion. This suggests a major opportunity and something that the world of packaging can do so much to support with a much smaller budget than typical allocated

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to R&D activity in more resource intensive areas – oncology, pain relief, diabetes and so forth. And for the patient community, in the US failure to adhere to regimen is estimated to cause around 125,000 US deaths annually, with non-adherence largely grouped under the categories of communication and complexity. It is suggested therefore that both Rx and OTC pharmaceuticals would benefit from enhancements in the communication and other smart technologies delivered through the packaging systems; communication and an improved patient experience via integration with the Internet of Things (IoT) and other digital technologies. Smart technologies The smart phone has the power and capability to drive adoption

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of on-pack solutions, be they RFID, NFC or more cost effectively, Smart Code systems. The provision of communication can be leveraged – as stated earlier the correlation between communication and adherence is well known. Smart phones now have the capability to read the variety of bar codes that can provide both fixed and dynamic links to allow access to e-PILs (electronic patient information leaflet), which can be presented with enhanced colours, be customisable with respect to the order of presentation, accessible in regards the data delivery and language, eg audio and so forth. A further benefit of this approach is the removal of the printed PIL. Manufacturing plants frequently cite that insertion of some of the


estimated 25 billion PILs annually lowers line speeds and efficiency. Given the annual cost of PILs is estimated at around £250 million with a huge tonnage of paper consumed, removal is therefore of benefit assuming access is maintained to all in some form. The next obvious development is to generate calendar reminders to take the drugs through the smart phone’s inherent capability. This is hugely powerful, connecting the patient, communications and adherence easily and cost effectively. The smart barcodes/ phones will also link and deliver other rich data, such as audible and video relating to patient information, ingredients, adherence and more, making access easy for those with visual impairment or in regions where literacy is an issue. To date, unit on-cost of chip technologies has been prohibitive. Smart barcode technologies with reduced costs; a secure two-way connection to an information platform with enhanced and associated content merely from scanning a standard printed product barcode using an app on a smart device – this must be good! A major advantage to brands implementing this technology is that there are no artwork changes nor physical

packaging modifications required, which are often a barrier to entry for some tech solutions. Gaming experience Upping the ante now, smart technologies utilising augmented reality (AR) capabilities are also proving valuable within the wider medical field. They can provide remote video support, training aids and real-time overlays during surgical procedures. Over recent years, a significant number of global companies have been experimenting with virtual or AR content as part of their media and communication strategies. Familiarity is building, as the growing middle classes in emerging markets are increasingly seeing AR in the home (often in the West for immersive gaming experiences). It is now but a matter of time before AR is more widely utilised for at-home medication uses – maybe visual overlay guides for newly diagnosed diabetics to assist with rotation of insulin injection sites as an example – again enhancing communications. Some animation companies now specialise in the pharma arena as the demand from the market for training and promotional

content grows. Thus, the creative foundations for adoption of AR as patient guidance are already in place. With the potential of hosted brand channels securely accessible from smart devices, via scannable packaging, delivery of educative AR content tailored to the patients’ needs is already available. Future opportunities We have started with global serialisation, which is clearly a scannable technology. The next steps seem logical in that Big Pharma might have to consider the coding of the individual pill or dispenser to facilitate the delivery of the specific data sets on the smart device. Specialist and complex medicinal needs could be managed and customised, and regimes easily scheduled and dispensed, thus taking any guesswork out of the mix for the patient. The benefits for early adopters of the technology within pharma are far reaching. Increased medicinal compliance improves quality of life and patient outcomes, decreasing pressure on health services. Conservatively the pharma industry can significantly improve its sales channel and the quantifiable results include better patient outcomes, increased sales numbers, and lower drug costs. On top of that brand value and product effectiveness elevate early adopters to be the prescribed ‘brand of choice’ for medical practitioners and ultimately for the brand to achieve the nirvana of peer group endorsement. So, growth of sales, improvements in patient outcomes, endorsement by the medical profession … what is not to like???

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Specialist solutions set Denny Bros apart By Denny Bros

he importance of labelling in the healthcare sector should never be underestimated. Whether it is giving clear and concise information or making sure that the right labelling prevents any simple mistakes or patient risk, the right healthcare labelling can have many benefits. For more than 75 years, Denny Bros has been leading the way in healthcare labelling. In what can be a demanding and heavily regulated field, often with tight deadlines, Denny Bros’ skilled and expert team is adept and highly experienced in providing the right service for every customer. Specialist services Denny Bros offers a range of specialist label printing services for the pharmaceutical and healthcare sectors. As a proud independent company, Denny Bros has the freedom to tailor their services and develop effective products to meet the specific needs of each project. Multi-page labels occupy the same space as an original single panel label and were originally invented and patented in the mid1970s by Denny Bros.

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Fix-a-Form®, the multi-page label, allows you to include detailed product information – such as descriptions, safety messages and dosage instructions – on the container itself. While there may be a temptation to increase packaging size as a result, multipage labelling is often a more cost-effective solution that makes better use of the available labelling space on a product. They are a trusted and secure way to meet legislative demands for detailed product and user information, by increasing the on-product space. It also has the added advantage of often staying with the product throughout its usable life, rather than being discarded shortly after purchase. Some multi-page labels can provide up to 120 pages of extra space and be tailored to suit the size, shape and construction of the product packaging. This can reduce patient risk as information is always kept with the medicine and helps ensure vital information remains on pack for the lifetime of the product. They can even display product information in multiple languages, meaning you only need to produce one version of your product label

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for multiple international markets, reducing costs and simplifying inventory. Labelling applications range from containers, vials and even syringes, where despite the often-small available surface a large amount of text, graphs and pictograms needs incorporating. Other print solutions at Denny Bros are available from patient information leaflets, to instrument pouches, single ply labels and more. Anti-counterfeit solutions Denny Bros has an extensive range of anti-counterfeit solutions to help safeguard pharmaceutical producers and the general public from harm. One of the company’s print features to help combat counterfeiting is a security 2D matrix which enables information to be encoded using either text or numeric data. Microtext is another solution offered enabling words to


Sponsored feature Denny Bros’ specialist production teams will over-print and verify patient-specific information, from a customer’s database onto labels which are produced to their exact requirements. This can vary from patient information to, in the case of clinical trials, batch numbers to help identify which is a placebo and which is a drug.

to minimise the risks involved in the production of labelling and packaging that cannot be eliminated through testing the final product. And there is a drive for constant improvement with a quality management system providing a basis for effectiveness and efficiency.

PS 9000:2011 accredited Based in Suffolk, but supporting customers across the UK and abroad, the company’s stateof-the-art production facility has been purpose built to meet the demands of the sector.

be printed below or at one point size which is almost unnoticeable to the human eye without the help of magnification. Unique serial numbers can also be incorporated into the print to identify and authenticate individual products. Over-printing The need for specialist overprinting services – made even more crucial by the pandemic – has seen a surge in new business for Denny Bros. The renowned printing and labelling company offer a bespoke service to life science and clinical trial customers in the UK and abroad.

Working in an environment with strict hygiene and cleanliness controls, Denny Bros is certified to PS 9000:2011, which governs all job handling and management processes within the pharmaceutical industry. This seal of approval gives customers confidence that all products are produced in an environment with strict hygiene and cleanliness controls and further gives customer’s peace of mind. Under the PS 9000: 2016 guidelines, the company’s Good Manufacturing Practice (GMP) system ensures that products are consistently produced and controlled according to quality standards. It is designed

Proud reputation Whatever the challenge, Denny Bros has a proud reputation within the industry for providing consistently high quality, secure and reliable service and products. For more information, or to discuss your requirements with one of Denny Bros’ advisors, please call 01284 701381 or email db@dennybros.com.

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Digitising the supply chain By Dr Alex Cole, Head of Strategic Marketing, CPI

The time has come for companies supplying the pharma industry to embrace digital technologies to increase sustainability, reduce costs and provide better patient support.

chain. Ensuring that end users, who

to act as an enabler for additional

what is in the pack, how to take

these companies have already

are ultimately patients, understand the drugs, as well as what side

effects could be experienced, is

not only key to ensuring regulatory

approval, but also supports patient

want to reduce. While that is true,

packaging also delivers significant value across the supply chain. It

clearly protects goods and gives information on how to transport and store the goods, but it also

gives information on the correct

use of the goods. For pharma, this is especially important. Ensuring that medicine packs have the correct shipping and storage

conditions is key to maintaining the quality of the product, especially

where that medicine requires cold

invested in serialisation, so now

is the time to start getting more value from that investment.

safety and adherence.

There exists today a whole plethora

More recently, driven by legislation,

through smart tags to complex

pharma has introduced and Packaging is a cost that we all

functionally is huge. Plus, many of

applied different printed codes,

including the global adoption of serialisation. In many markets, each pack has its own unique

identifier. For example, in the EU,

driven by the Falsified Medicines

Directive, each pack has a unique identifier, ie a DataMatrix symbol that includes at least product

of technologies from printed codes electronic systems that can add

value to packaging in the pharma industry. However, we should

concentrate on the value rather than the technology at play, the

industry needs to be technology

agnostic, focusing on the solutions that provide that value. So where could we add value?

code, serial number, batch number

Supply chain security (and

each pack is therefore uniquely

The strict controls, driven by

and expiration date. As a result,

coded. Many pharma companies have adopted the same

DataMatrix standard which means that the possibilities for packaging

patient safety)

legislation and regulation, that

exist within the pharmaceutical

industry are designed to ensure high degrees of demonstrable

17.


control exist while the product

a way to better engage with the

we bring together companies

pharma company. As the pack

improved adherence and patient

solve an industry-wide challenge

is within the ownership of the

progresses on its journey towards the patient, these controls lessen with the last step of the last

mile (post healthcare provider

involvement and prior to patient usage) potentially having

no controls or monitoring in

place. Serialisation has already demonstrated the possibilities

of a co-ordinated approach to

anti-counterfeiting and product tracking, and the opportunity

exists to take a similar approach to important areas such as

maintaining appropriate product

patient potentially supporting outcomes. A simple use case

here would be to leverage the

DataMatrix codes on each pack

to give the patient a digital link to an electronic patient information leaflet (PIL). This e-PIL can be

regularly updated at the software

have visual impairments or speak

a different language to the market in which the medicines were purchased.

leveraging the connectivity and cloud infrastructure already

deployed. Building in sensing

has been handled and stored. As

opportunity for pharma to

There is currently significant embrace digital supply chain technologies to reduce their

costs, improve their sustainability (through reducing losses and

improving patient adherence), and enhance patient adherence.

Patient outcomes (and

On the whole, the technology

Driven, in part, by the increasing

up approach and large-scale

increasingly digitally aware

and knowledgeable. There is an

opportunity to use packaging as

18.

scaled by CPI, can quickly be

of services for the patient

Embracing innovation

general population is becoming

which can be developed and

It also enables personalisation

there are concerns or lack of

home over lockdown(s), the

exist, electronics, such as that

throughout the supply chain.

a result, pharma can apply a

use of digital solutions in the

impact. Where hardware gaps

RFID, enables it to be tracked

pharma through to patient. As

engagement)

longer term economic and society

site) smart tags such as NFC or

pack, during its journey from

availability at a critical juncture.

definition, this is truly a win-win for

through wireless (non-line of

handling and storage of the

the patient through non-

benefit of the industry.

unique ID through printed codes,

understanding of the actual

costs and potentially impacting

sharing expertise for the mutual

deployed. Giving each pack a

and control lead to a lack of

destroyed resulting in unnecessary

together, pooling resources and

all involved, as well as providing

The lack of unit level monitoring

acceptable products can be

own. Here, all partners can work

to them, eg to support them if they

waste reduction)

a direct consequence, perfectly

or stakeholder to solve on their

With the correct challenge

to the patient specifically tailored

Supply chain efficiency (and

information about how a product

that is difficult for one company

end and also provide instructions

storage environmental conditions.

worst-case scenario to where

in the pre-competitive space to

exists; what is missing is a joinedimplementation alongside the evolving digital healthcare

infrastructure. One way we could do this is to redeploy the novel

collaboration models such as the CPI “Grand Challenges” where

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and data logging, such as for

temperature, humidity or shock,

can bring additional value through high granularity supply chain

environmental monitoring. This can give demonstratable assurance

of the maintenance of the correct supply chain conditions and ultimately drug condition.

Now is the time for companies to start developing and deploying

these digital product solutions to make the pharma industry not

only more sustainable but reduce costs and provide better patient support. As an industry, we need

to innovate as well as learn from other industries that are already adopting digital technologies.


Packaging Innovations & Empack

16 & 17 February 2022 | NEC, Birmingham

Be part of the UK’s leading packaging event!

It was excellent to meet new and potential suppliers and to update myself on the latest developments around sustainable packaging. David Garbutt, Head of Procurement

Book your stand

www.packagingbirmingham.com


Finding the right balance By Yves Steffen, Director Global Sustainability, SHL Medical AG

With pressure from customers, investors and society, it is not always easy to set the right targets and to keep control over activities that will drive companies to a sustainable future.

ow can you ensure you

set the right targets and create the transparency required of your products for external partners? How can the right focus areas be identified, and success made measurable? A common way to calculate the footprint of a product is life-cycle analysis evaluations, showing in an easy and understandable way where the biggest contributing factors are to continuously improve your product in the materials, production methods and supply chain used. Life Cycle Assessment (LCA) is the standardised method of calculating and evaluating the impact of, for example, a product on the environment throughout its life cycle. During an LCA, a large amount of emission data is collected – from energy production, waste, raw materials, etc. During the impact assessment of an LCA, the different emissions are united into actionable

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numbers, which are converted into one unit that translates into one impact category. One relevant impact category is global warming (measured in kg CO2eq), which is an indicator of global warming potential (GWP) caused by greenhouse gases (GHG) emissions.

The LCA data can be divided in three major areas: raw materials used for manufacturing, energy consumption to produce, and packaging and storage/transport. To set the right priorities, some key elements to reduce the environmental impact on these categories will be discussed.

GHG are usually categorised in three different scopes:

SCOPE 3 SCOPE 1

Emissions are direct emissions from owned or controlled sources

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SCOPE 2

Emissions are indirect emissions from the generation of purchased energy

Emissions are all indirect emissions (not included in scope 2) that occur in the value chain of a company, incl both upstream and downstream


As seen in the graphic, GHG emissions are separated into three categories. The main driver for scope 1 and 2 emissions in medical device manufacturing (injection moulding) comes from energy used to run the manufacturing equipment and equates to about 20–30% of the overall GHG emissions of a medical device company (looking at the overall consumption including scope 3 emissions). The most common way to reduce CO2 emissions here is offsetting by funding forestation projects or other projects eliminating CO2 from the atmosphere. However, there are more impactful and sustainable actions a company can take such as sourcing renewable energies to run their plants or reduce overall consumption of energy by improving manufacturing processes and invest in innovative technologies. Scope 3 are emissions where the manufacturer has no direct impact, as they are contributed by their suppliers or from the up- and down-stream emissions linked to their product and, usually, are the biggest contributors to the overall GHG emission of a manufacturer. Reducing the GWP in design and manufacturing of medical devices can be done by applying various focus areas, such as production efficiency (reduction of waste), renewable energy to run manufacturing and introduction of alternative plastics with a reduced global warming impact (GWI).

Reducing plastics impact Sustainable plastics are materials that can be produced on demand without depleting nonrenewable resources or disrupting the established steady-state equilibrium of the environment and key natural resource systems. In contrast to the traditional linear economy model, these materials exhibit a circular economy framework, which comprises ‘make, use, recycle’ closed-loop cycles. In the sustainable systems, the rate of resource regeneration is equal to or greater than the rate of resource utilisation. Such materials vary enormously and range from highly recyclable materials such as PET that can be reprocessed an indefinite number of times without requiring additional mineral resources, or polymers derived from natural and renewable sources such as wood (cellulose), vegetable oils, sugar, termed biopolymers or bioplastics. Focusing on the raw materials used for production (accounting for about 50% of the overall emission of sub-assemblies), alternative plastics can be a good tool to reduce the footprint of the products. Especially over the last few years interest in alternative solutions has increased and many suppliers offer a broad range of products to choose from with different impacts on manufacturing. Generally, there are four categories of product differentiations: •

Plastics with reduced GWP – same product but with optimised production and

supplier to reduce the environmental impact Recycled content including plastics – PCR (Post Customer Recycled), PIR (Post Industry Recycled) Biobased plastics – Material partly or totally derived from biomass, eg corn, sugarcane, cellulose, instead of crude oil Biodegradable plastics – Material that undergoes degradation in the environment in a relatively short time

The reduction of GWP and the price of the material is usually directly proportional – the evaluation of the LCA data can also help here to find the right balance between reduction of emissions and increase of product price to find a meaningful solution for selected products. The third area of focus – packaging, transport and storage – also has a big impact on the overall emission contribution of the sub-assembly devices. Looking at your supply chain and avoiding energy consuming storage has a big impact on energy consumption and emissions. Developing your product to not require special transport and storage can also help to reduce the financial efforts and allow for more flexibility to ship products. Continuously improving on the three focus areas illustrated below can help reduce the overall footprint of the product by up around 50% compared to establish design and manufacturing setups.

DRIVE OPTIMISATION

DEFINE FOCUS AREAS & PRIORITISE

CREATE BASELINE & TRANSPARENCY 1.

Map process and value chain

1.

Set targets and objectives to

1.

Definition of performance KPIs to

2.

Use of LCA software to create

2.

Definition of roadmaps to

2.

Integration of sustainability mindset

of your product

a credible data baseline

reduce emissions & waste

continuously reduce emissions

measure improvements

in the culture of your business


Sponsored feature

Accelerating the degradability of plastics By Natupharma

We recently caught up with Mads BødtcherHansen, CEO and founder of Natupharma A/S, in Denmark, to discuss his new Eco Packaging project which appears to solve several packaging industry concerns. ads, can you give us a brief introduction to Eco Packaging and tell us what made you decide to focus your company’s efforts on this particular project? Being in vitamins, minerals and Omega 3 oils, Natupharma uses a lot of plastic pots. I was looking for an eco-alternative but couldn’t find one that was fully biodegradable. Now, working with a manufacturer in Denmark, we have created our own solution and that is what we are offering today. What is the difference between degradable and biodegradable plastic? Degradation is the process that deteriorates plastic material. Biodegradation is degradation that occurs using microorganisms and

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transforms the material into CO2, H2O and biomass or CO2, CH4 and biomass. What is the difference between an oxo-biodegradable product and yours? An oxo-biodegradable product needs oxygen to help break it down. These have been linked to communicable disease in humans, plants, and animals. Our Eco Solution uses a completely different process using microorganisms. Phytotoxicity tests have been conducted and show that polymers containing our biodegradable compound are environmentally safe, with no microplastic remnants from the degradation process. That is good to hear, but what about the resultant biodegraded product – could that be harmful? Methane, carbon dioxide and water occur naturally in the environment, so no. Which resins will work with your Eco Packaging solution? Our technology is compatible with traditional plastic resins such as PE, PP and PS. Does your process affect shelf life? There is no material change to

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the pots’ properties until they enter conditions such as aerobic, anaerobic, waste and marine water. Are your products recyclable? Our products are fully recyclable and can be placed in the normal plastic waste collection bin. Are your products suitable for food preparation and packaging? All our products are Food Safe and in full compliance with all relevant EC regulations for food contact materials. Is it suitable for pharmaceutical products? We have had no problems up to date, but it is the responsibility of individual companies to carry out any testing on their own products in line with industry standards. Why can’t we just use recycled plastics? Currently less than 10% of the world’s plastic is recycled – this is not a solution to the mounting problem until all countries are able to recycle better. But could your additive be added to recycled plastic? Yes, the additive works in the same way with recycled plastics.


Sponsored feature You also use Braskem’s “I’m Green” polymer on some of your pots, please tell us more. Braskem’s “I’m Green” polymer is made from sugar cane from Brazil, and it has been proved to be CO2 neutral and sustainable. Many companies are now using I’m Green, but we are the only one to add an additive that uses microorganisms to break down the polymer – this is the basis of our patent. Ah yes, I understand that you have a patent pending. How likely is it to be approved? We have been down this road for some time now and are pleased to say that we have only received positive statements from the patent authorities. Therefore, we have applied for a global patent including all major regions. What guarantees can you offer that the products will degrade as stated? We offer a guarantee that if the additive is added at the required 2% by weight, any product manufactured with PP, PE or PS resin will degrade within 10 years. This is substantially less than the estimated 450 years+ of standard plastic without our additive. Your Eco Packing sounds a novel technology; do you think the packaging industry is ready? Absolutely, yes! When it comes to plastics and sustainability,

packaging professionals are aware there is an attitude or perception problem – 69% of respondents in the 2018 Sustainable Packaging Study felt a high level of environmental concern around plastic packaging. Much of that concern focuses on the visible and visceral problem of pollution in our oceans and waterways. It sounds expensive We believe it will only add between 1% to 5% to your overall packaging costs. This in turn should have little or no impact on the retail price of the finished product. We have found that in the majority of cases, it attracts a greater demand for the products with the eco credentials. Do you think consumers really care about packaging? A recent international study by Unilever revealed that one third of consumers are now choosing to buy from brands they believe are doing social or environmental good. This equates to an estimated £832 billion opportunity for brands to make their sustainability credentials clear. Can brands use their current pot manufacturers, and if so, do pot manufacturers have to change their equipment to manufacture your pots? No, they run like any normal product with the additive added at

2% by weight, just like colour pellets. We can give them full guidance and put them in touch with other manufacturers who currently run our materials. This process is transferable to most machines;

with your permission we can talk to your packaging manufacturer. Do the pots come with your logo? No, the pots lend themselves to have either a company name or logo on the bottom. Who is currently using your technology? We work on strict NDAs, but I can tell you that Wasdell Packaging are happy to say that they work with us on this. What are the next steps for companies interested in this technology? Just get in touch with us directly.

Contact Martin Greaves Sales Director Tel +44 07951 414616 sales@natupharma.uk.com

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Designing for sustainable packaging By Alison Bryant, Communications Director Healthcare Plastics Recycling Council

With pressure from customers, investors and society, it is not always easy to set the right targets and to keep control over activities that will drive companies to a sustainable future.

other design and manufacturing requirements. Medical device

and packaging designers and

engineers should prioritise product performance and functionality,

sterility, efficacy, safety, and ease of use when there is a conflict

between these requirements and the ability to recycle.

These guidelines are also considerate of the new

opportunities presented with Design guidelines

While the most critical requirement for all medical applications

is patient safety and product

efficacy, design considerations to improve recovery and recycling of healthcare plastics are also

important. The Healthcare Plastics Recycling Council has developed design guidelines based on

multiple pilot studies and input he global market for

from industry experts, including

packaging was £14.6

packaging designers, healthcare

plastic healthcare

resin manufacturers, device and

billion in 2020, and market

sustainability professionals, and

analysts project that it will grow

recycling experts.

2025. While healthcare plastics

These guidelines concentrate on

market by volume, this is not an

consider the broader context of

when most of it is clean, non-

operations and protocols, overall

by 5%+ annually to £18.8 billion by

business requirements and many

only make up 6% of the global

the context of recyclability, but also

insignificant amount, especially

functional requirements, hospital

infectious material heading straight to landfill.

There are a number of reasons

why healthcare plastics are not

being recycled more widely and

the rapidly growing advanced recycling industry. Healthcare

plastics are well suited and can be a valuable feedstock for

advanced recycling. Because

of the increased environmental impacts associated with

advanced recycling compared to mechanical recycling, advanced recycling is a complementary

solution to mechanical recycling. These design guidelines are

focused on enabling mechanical recycling first, with advanced

recycling as a secondary and complementary solution.

Desirable design practices for healthcare plastics •

Design with mono-material

Use polyolefin seals or gaskets

design and manufacturing

recycling.

through product use, disposal and

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Combine chemically compatible or jointly

materials are required.

Use materials easily separated during automated recycling

processes, if multiple materials

plastics at every point along

the value chain – from product

on polypropylene bottles.

processable plastics, if multiple

consistently. The reality is there are barriers to recycling healthcare

whenever possible.

are required.

Use breathable plastics as alternative to paper.

Minimise paper labels and components.

Use water-based adhesives.


Allow for bottles and bags

used as a replacement for the

before disposal.

some sterilisation methods,

to be fully drained with ease

cellulose-based label. Additionally,

Provide information on content

such as gamma radiation and

for easy identification of

e-beam radiation, do not require

residual liquids.

Minimise use of pigments.

breathable films and could also bottle is a good example of this.

Less desirable design practices

While it does not provide the value

Using rubber seals on

polymer stream, it still avoids any

Combining incompatible

and the recycled material can

based plastics into one

applications.

Welding, gluing or molding two

Marketable thermoplastic

Combining plastic film with

Polyethylene terephthalate and

Using metallised plastics,

High density polyethylene

plastic.

Using PVC.

for healthcare plastics

• • •

• •

of a mono-material recycled

polypropylene bottles.

necessary labour of separation,

bioplastics and petroleum-

be utilised for a number of future

product.

components of unlike plastics. paper in packaging.

metals screws, or grommets in Using lead.

recycled resins and blends

Eliminating multiple material

healthcare product

types within one discrete

The best practice is to utilise

mono-material designs wherever possible. Currently, the most

variants (PET, PETE, PETG) (HDPE)

Low density polyethylene (LDPE)

Polypropylene (PP) Polystyrene (PS)

Blends of polypropylene and

be potential alternatives for

certain products. However, not all

product and packaging materials are compatible with the radiation methods of sterilisation. Overall,

both alternative films and methods may provide solutions to this design challenge.

These design practices are

focused on maximising the

opportunity for mechanical

recycling. Advanced recycling

technologies can be successfully used to recycle multi-material products and multi-laminate

packaging at higher energy inputs

and corresponding costs, although yields may be reduced, depending on the technology.

polyethylene (PP and PE)

Conclusion

thermoplastic elastomers (PP/

use of multiple plastics without

Blends of polypropylene and TPE)

marketable recycled plastics are

Eliminating multiple material

polyethylene, polypropylene,

packaging

healthcare product can be made

healthcare packaging presents

types, there will be less labour

opportunities. Much of the sterile

level in the plastics lifecycle. If

is packaged in a thermoplastic

used, materials easily separated in

label made of paper. The paper

float tank, optical sorter, air jet,

allows for printing of the product

material options are not available,

enter and exit the package during

thermoplastics. A thermoplastic

A breathable thermoplastic,

thermoplastics, such as polyester,

types within healthcare

and high impact polystyrene. If a

The use of multiple materials in

with just one of those polymer

some unique challenges and

and resulting expense, at every

product used in operating rooms

multiple material types must be

film laminated to a micro-porous

recycling processes (eg in a sink/

provides two functions in that it

etc) are more desirable. If mono-

information and for the sterilant to

a good practice is to only use

gaseous sterilisation processes.

elastomer seal on a polypropylene

such as DuPont’s TYVEK, could be

Products designed to limit the sacrificing their intent for use will increase their recyclable

potential. Additionally, the largest challenge to optimum yield of a viable, economic mixed plastic waste stream is the reduction or elimination of common

contaminants, such as paper,

metals, rubber seals and liquids.

Elimination of these contaminants would increase the end product value and improve processing and separation equipment

capacity and efficiency. Ultimately, designing healthcare products

and packaging with recycling in

mind is an important part of the solution to reducing waste and providing a valuable material stream for recyclers.

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Making pharma packaging sustainable By Nazneen Rahman, CEO YewMaker, Director Sustainable Medicines Partnership

The NHS has announced an ambitious decarbonisation plan to become net zero by 2045. How can pharmaceutical packaging rise to this challenge? he climate emergency is

a health emergency. The

consequences of climate

change – heatwaves, air pollution,

flooding – increase health burdens and compromise health services. It is a tragic irony that healthcare is one of the biggest contributors

to carbon emissions. If healthcare were a country, it would be the

fifth largest emitting country in the world. Healthcare needs to clean up.

The NHS is pioneering the changes the world needs, as set out in

their radical roadmap, ‘Delivering

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a Net Zero Health Service’. The

Today, every medicine package

packaging by at least 25% by 2025

leaflet, even if the medicine is only

plan includes targets for reducing

and for ensuring packaging is from renewable or recycled sources

and is fully recyclable. Medicines

account for 25% of NHS emissions and sustainability commitments

from suppliers will be required from as soon as 2022. To deliver these sizeable goals, pharmaceutical packaging will need to think outside the box. Going digital

There is a simple solution that

would reduce packaging weight, stop millions of medicines being

discarded during manufacturing,

save millions of trees, save enough energy to power thousands of homes, and would enhance

patient experience and adherence. It sounds like a miracle, but it is the humble change of removing the

paper patient information leaflet

from inside medicine packets and providing the information in more patient-centred formats.

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must include a patient information administered in hospital (when the leaflet is not given to the patient), or if it is a tablet you have taken,

every day, for years. To add insult to injury the leaflets are not userfriendly and are rarely read. The

writing is too small, too technical, and mostly not relevant. Most

people would prefer searchable,

online, up to date information that could be personalised, read out

if we are visually impaired, easily translated to our language, and

with links to videos to show us how to use medicines, like inhalers.

Written information must always be accessible to everyone that wants it, but we need to move

to digital information being the

default, with paper being available only when needed. This simple

change would have huge positive

environmental impacts and would substantially reduce the volume and waste of pharmaceutical packaging.


Plastic to plastic

proposed alternatives. Exciting

instead of next in a line. The NHS

used throughout healthcare and

that return polystyrene protective

of supply chain collaboration

Single-use plastics are widely

are a major focus of the NHS net zero plan. Addressing plastics in pharmaceutical packaging is

constrained by regulations that stipulate virgin input materials must be used, and that waste

should be incinerated. Progress has also been hampered by

the assumption that composite packaging, like blister packs,

is not recyclable and that it is

innovations in plastics recycling inserts and PVC blister packs to virgin raw materials is realistic,

within this decade. To keep our options open, we must guard

against knee-jerk assumptions,

environment overall than some

chain by 2022.

multi-stakeholder partnership

comprehensive comparisons when making our choices.

Collective, coordinated, committed

recycled and can be better for the

reduce emissions with their supply

when appropriate, and do diligent,

of pharmaceutical packaging

nuanced.

packs has good potential to be

demonstrate engagement to

The Sustainable Medicines

The Sustainable Medicines

The high-grade PVC used in blister

and is asking NHS suppliers to

capitalise on the unique aspects

always better to replace materials like PVC. The realities are more

has recognised the importance

Partnership

action across supply chains will be critical to tackling climate change.

This will require many of us to work in new ways, with new partners, as we become cogs in a wheel

Partnership is a not-for-profit

of the stakeholders needed to

make medicines environmentally sustainable. We include

partners from pharma, the NHS,

packaging, distribution, pharmacy, governmental bodies, recycling, research, academia, designers, health tech, entrepreneurs and many others.

We are undertaking six projects aligned to six pillars needed to make medicines sustainable.

Digital patient information and sustainable pharmaceutical

packaging are two of our projects. If you are interested in joining us, we would love to hear from you: www.yewmaker.com

27.


Unique device identification system comes into force By Fabien Roy & Jessica Koffel, Hogan Lovells*

The recent implementation in the EU of the Medical Devices Regulation has introduced new labelling and packaging requirements. he Medical Devices Regulation 2017/745 (MDR) entered into application on 26 May 2021 and establishes new requirements for medical devices, including the Unique Device Identification System, intended to allow the identification of medical devices and increase traceability. While the system is already used in other jurisdictions, its implementation is novel in the EU and implies additional labelling and packaging requirements, an overview of which is provided in this article.

assignment of a UDI to a device or its packaging, the registration of information within the UDI database in EUDAMED, including a Basic UDI-DI, which is essentially an access key intended to identify and connect device groups, and the affixing of UDI carriers. Manufacturers must also ensure that a new UDI-DI is generated following certain changes impacting the identification or traceability of a device and periodically update the information contained in the UDI database.

New responsibilities The UDI System rests upon the use of a Unique Device Identifier (UDI) for all medical devices placed on the EEA market, other than custommade and investigational devices. A UDI is as a series of numeric or alphanumeric characters, created through a globally accepted identification and coding standard which allows the identification of a specific device. It is composed of a UDI Device Identifier (UDI-DI), specific to a device model and manufacturer, and a UDI Product Identifier (UDI-PI), relating to information on the unit of device production such as the lot number, serial number or expiration date.

Importers and distributors in turn are required to verify that a UDI has been assigned prior to placing or making available devices on the market. Moreover, all economic operators, healthcare institutions and healthcare professionals will need to comply with storage requirements for UDIs.

Manufacturers are responsible for complying with UDI related requirements. These include the

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In addition to improving device identification and traceability, the UDI System will further ease the sharing of information, enhance the effectiveness of post-market surveillance and improve monitoring by competent authorities. Packaging requirements Following the assignment of a UDI,, as a general rule, manufacturers must place a UDI carrier on the label or on the device itself and on all higher

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levels of device packaging (eg cartons or cases), except shipping containers. The UDI carrier allows the transmission of the UDI information. In principle, it must appear in a form that uses Automated Identification for Data Capture (AIDC) (eg barcodes, smart cards, biometrics and RFID), and a human readable information (HRI) form consisting of a legible interpretation of data characters encoded in the UDI carrier that can be read by people. Under specific circumstances, these format requirements may be adapted to accommodate space constraints. The manufacturer will need to ensure the readability of the UDI carrier throughout the normal use of a device’s entire lifetime. In addition, the MDR foresees specific UDI requirements for certain types of devices, including: • Reusable devices: the UDI carrier must be permanently affixed on the device itself. It should not however interfere with the safety or performance of the device and should remain technically feasible. • Implantable devices: the UDI must be identifiable before implantation, be marked on the lowest level of packaging, include at least the serial number for active implantable devices, or else, the serial number or lot number. • Systems and procedure packs: as a general rule, the UDI carrier should be affixed to the outer packaging. Device contents must also bear a UDI carrier on the packaging or on the device itself, with exceptions provided for certain individual single-use disposable devices contained in a system of procedure pack and devices that are exempt from bearing a UDI carrier. • Configurable devices: a UDI

must be assigned to the entire configurable device and the UDI carrier must be placed on the assembly that is most unlikely to be exchanged during the lifetime of the device. Components that are otherwise commercially available will need to be assigned a separate UDI. Device software: a UDI must be assigned at the system level of the software which is commercially available on its own and constitutes a device in itself. The UDI must be affixed on each packaging level where a physical medium is provided or otherwise be available through electronic means. Single use class I and IIa devices packaged and labelled individually: the UDI carrier must only appear on the higher level of packaging, unless the healthcare provider would not have access to this higher level of packaging, in which case, the UDI carrier must appear on the device packaging. Devices exclusively intended for retail point of sale: the UDI-PIs in AIDC are not required to appear on the point-of-sale device packaging.

Timeline While the obligation to assign a UDI has been applicable since 26 May 2021, the requirement to place UDI carriers on devices, labels or packaging will be phased in over several years in accordance with the following periods and device classes: • Class III and implantable: from 26 May 2021 • Class IIa and IIb: from 26 May 2023 • Class I: from 26 May 2025 For reusable devices which must bear the UDI on the device itself, the labelling requirement will apply two years after the date of application, ie 26 May 2023, 2025 or 2027.

*The authors would like to thank Mélanie Carrere Fontana for her assistance in the drafting of this article.

29.


Healthcare barcodes are part of our digital future By GS1 Healthcare

What could barcodes mean to the future of healthcare and what role could they play in a world of increasing digitalisation? The answer is surprising and exciting. arcodes have been an essential part of packaging for nearly 50 years. They are an integral part of our everyday life, including during healthcare provision. The barcode is a fundamental healthcare tool – but not just any barcode. Standardised barcodes contain standardised information so that everyone knows the rules for how to read and process the symbol. Today, many jurisdictions require regulated healthcare product packaging to include a globally standardised GS1 barcode that is used to enable product identification, traceability, verification of authenticity and, most importantly, to facilitate

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patient safety actions. It is commonplace in many countries and healthcare settings to see product barcodes scanned by caregivers at the point of medicine dispensing or administration or to record healthcare actions in patient records. For brand owners, barcodes are increasingly contributing to sales and marketing activities and are unlocking the ability for patients and caregivers to access additional information about a product – electronically. There is no question that the barcode is a necessary and important part of packaging design, and it would be highly detrimental to not have globally standardised barcodes on healthcare product packaging.

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Types of barcodes We see different types of barcodes on healthcare products. On some healthcare products, we see the familiar one-dimensional barcode that goes beep at the checkout. This contains only a globally unique identification number, which is a Global Trade Item Number (GTIN). On higher risk products, we see either the GS1 DataMatrix or a linear barcode called GS1-128. These symbols contain the GTIN plus data such as the batch/lot number, serial number and an expiry date. This extra information is critical for accurate dispensing, recording of data in medical records and traceability and stock management, all of which contribute directly to patient safety.


Generally, the barcode chosen is influenced by the clinical risk associated with the product, pertinent regulatory requirements, information to be encoded, packaging size and much more. If a 1D barcode is chosen, it is likely due to the product being scanned with laser-based scanners – including the handheld scanners seen at point of sale in a reducing number of pharmacies – which can only read 1D barcodes. You need a camera-based scanner to read any 2D symbol. Barcodes containing information in addition to the GTIN (eg batch, expiry date or serial number) must be applied on the production line. Production line printing is a separate operation from pre-printing the packaging in bulk and requires a range of additional technology capabilities within the organisation printing the barcodes. A simple vision What then is future of barcodes in healthcare? The vision is simple: one single barcode that can be leveraged by all and that can even be a tool for engagement with patients and clinicians. How does this happen? Firstly, the company applying the barcode needs to select the type of

barcode and encode the data that is appropriate, taking into account the factors mentioned above. Then, there needs to be an understanding that the barcode is part of the toolkit needed to facilitate access to electronic information for patients and clinicians. We are often asked: Don’t you need a QR code for that? The answer: No. Coupling the GS1 barcode on the packaging with an app that routes the user to the appropriate location when the barcode is scanned and having all of this based on the GS1 Digital Link standard is the key. GS1 Digital Link describes how to use the information in a GS1 barcode to lead to multiple sources of information – clinical and pharmacological information, instructional videos and information for patients, all in the right language for the user. Scanning the GS1 barcode with a GS1 Digital Link-enabled app to access healthcare product e-leaflets is already seen in Japan. We have a vision for the future, and we need to work together to achieve the vision. We know that having one single barcode on the pack is the solution that will best

facilitate patient safety, avoid errors, and remove the challenges faced by doctors, nurses and pharmacists when presented with multiple barcodes. We know that the need to access digital information is an ever-increasing reality. What then needs to happen to ensure the GS1 Digital Link standard is able to facilitate healthcare’s digital information needs? To use the GS1 barcode to address even more industry needs, we need apps that connect these barcodes to authoritative information on the web. We’re working to encourage the development of new apps and additional functionality in existing apps to do this. Healthcare stakeholders from across all business functions are working with us to make that happen. After 50 years, the role of the barcode is going through a revolution and digitisation is one of the drivers. The invitation is there for you to be part of it. Please, join us! GS1.org/healthcare


who can give their flexible packaging the power of sustainability? you can. The Power of Sustainable Packaging. Today’s consumers are more environmentally conscious than ever — that’s why we’re committed to innovative flexible packaging solutions that are good for the environment and the bottom line. At Sun Chemical, helping you meet your sustainability goals just comes naturally.

Request your copy of Sun Chemical’s Guide to Sustainable Packaging at sunchemical.com/powerofflexiblepackaging.

working for you.


Labelling in the pharmaceutical industry By Neel Madsen, Journalist

Printing, coding and labelling errors can have serious consequences when it comes to pharmaceutical products. Recalls are costly and can damage the brand owner’s reputation in an industry where reliability and compliance are paramount. hile some commercial printers have adapted their production to making facemasks, the upsurge in the use of hand sanitiser has seen demands for durable labels rocket during the COVID-19 pandemic. In the pharmaceutical industry, millions of vials filled with the newly developed vaccines have needed printed labels, as well as boxes in which they are supplied. This unprecedented high level of demand has tested label and packaging manufacturing, and the associated supply chain, to the limit. Normally medicines sold within the EU must be printed in the local language, but such has been the

pressure on the manufacturers during this crisis that the Member States agreed a temporary exemption from this obligation allowing outer and inner labelling, as well as the leaflets included, to be printed in English only. However, each individual product must still carry a unique code that enables full verification and traceability, as well as quality control and product recalls. These requirements are met by using variable data printing that can assign a number of different codes and marks, which are recorded and verified. The labelling process is monitored by 100% inspection systems, so that each label or folding carton box is error-free, and every single one accounted for. These rigid demands should be seen in the light of a forecast by Allied Market Research predicting that the global pharmaceutical

packaging market will grow from $88,880 million in 2019 to $144,233 million by 2027, equivalent to a CAGR of 6.1%. Labelling and coding For pharmaceutical products, a printing system must be able to produce extremely fine details and small text in high resolution for excellent readability and scanning. Digital printing is ideal for overprinting with variable data, for smaller batch sizes and when producing multiple SKUs. Serialisation and adhesives used for pharma products must be fit for purpose. Avery Dennison has recently introduced a new pharmaceuticals portfolio of materials with compliant adhesives. The range of facestocks has been specifically designed for digital printing with UV inkjet, water-based inkjet, dry toner, thermal transfer, and direct transfer.

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Serialization, as required by law, assigns a unique, random code to each saleable unit. There are many inkjet digital and thermal printing systems on the market for adding this type of coding and marking. They can be integrated directly on the printing press, converting line, or on the filling line at the packing company. The K600i from Domino is a monochrome UV inkjet printer that runs at speeds up to 200 m/ min adding alphanumeric codes, barcodes, QR codes and other variable data. It can print with a variety of inks, including UV LED ink cured by a Phoseon FireJet module, for increased productivity and reduced energy costs. Medical technology company Becton Dickinson in Spain chose this high-speed printer to digitally add unique codes onto the outer paper packaging of needles and syringes used for COVID-19 vaccines. Incorporating the K600i printer into their packing line

resulted in drastically reduced miscoding rejects, with no compromise in print speed, and significantly improved printing costs for Becton Dickinson, according to Domino. Tactile marks such as obligatory warning triangles and Braille can also be produced with inkjet printing with special varnishes applying a thicker layer of ink for a raised effect. One example is Xaar’s inkjet Print Bar System, which is capable of laying down high-build varnishes at high speed in one single pass. This High Laydown Technology, which is compatible with a range of Xaar’s printheads, produces a variety of tactile effects and satisfies the dimension specifications for Braille and warning triangles for pharma packaging. Extended functions The applications in pharmaceuticals are extremely varied. Printed labels are not only applied to various shapes

of bottles and jars, but also in more challenging applications for syringes, pens, inhalers, cartridges, ampules and medical fluid bags. With other types of packaging, such as folding cartons and blister packs, the print is most often applied directly to the pack by dedicated converting systems. One of the most difficult applications in this sector is multilayers labels. These come in a variety of versions under different names and consist of multiple layers of substrate printed and folded, or glued together, to extend the surface space available. Whether they are peel & reveal labels or booklets labels, they can be used to provide information about dosage, usage, side effects and other statutory information in multiple languages. For the ultimate in utilisation, the substrate is often printed on both sides, including on the adhesive. Servo-driven narrow web flexo and hybrid presses can be fitted with delam/relam, turner bars, extra towers for over-laminating substrates and crossover modules to produce multi-layer labels inline in one pass, but these functions can also be incorporated on the finishing line and performed offline. Multiple pre-printed webs can be joined and then laminated on top of one another using in-register lamination. Labels that perform a security function are also commonly used to protect the product, the brand and the end user from counterfeiters. Since 2019, all pharmaceutical packaging in the EU must include a form of tamperevident closure. This secures the content so that any attempt to open the packaging will destroy the label and/or part of the box itself.



Sealing labels are manufactured with strong adhesives that are resistant to water, heat and solvents, and can be printed for extra security or branding purposes. The trademarked Label-Lock range from Mercian Labels even reveals an ‘opened’ message on the pack once the label has been removed and can be customised according to the specific application. Printing for pharma The onus is on the printing company to produce fault-free labels and packaging in this highly regulated sector. The exact requirements imposed depend on the type of pharmaceutical product. Narcotic drugs and patent-protected prescription drugs are tightly controlled with only certified pharma converters allowed to manufacture labels and packaging. Morphine, benzodiazepine and similar high-value narcotic drugs are, in addition to control by pharmaceutical regulators, also

subject to law enforcement supervision. Prescription drugs are vulnerable to counterfeiting and therefore of high value to the brand owner, so must also be produced at printing companies that specialise in pharma. The labels and outer packaging usually display basic graphics, in one or two colours with low ink coverage, to identify the contents at a glance, with multiple types of codes and often tamper-evident labels or smart technology added for safety, traceability and brand protection. In print factories where these types of pharmaceuticals products are made, strict regimes are in place with complete line clearance implemented between jobs, full reporting in place and every label and pack accounted for. Labels and cartons for prescription drugs that are out of patent can be printed at general converters able to comply with regulations. Again, the design will be fairly simple, but the control level is less

demanding. When it comes to over-the-counter medicines and nutraceuticals, the level of control is lower, and a much wider range of converters are active in this market. In addition, these products are competing for the consumers’ attention, so more complex graphics are deployed for instant shelf appeal. High-value products will still need to be protected against counterfeiting.


Sustainable packaging: a challenge for pharma and healthcare By Jane Bevis, Chair, OPRL Ltd

While COVID has been the overwhelming focus for pharma and healthcare over the last 15 months, wider non-health sustainability concerns haven’t gone away. ustainability is high on the agenda, but the added complexities of medicines regulations and the global nature of pharma companies make progress protracted and uncertain. “We’ve been slower to tackle these issues than FMCG, partly because we’re less in the limelight, but mainly because product safety and efficacy are our first priority,” comments one industry figure. COVID has increased consumer expectations on sustainability and new regulatory measures will require action. “Bayer is fully committed to reduce the impact its packaging has on the environment. However, the complex frameworks of the heavily regulated healthcare industry with our absolute need to maintain product quality and efficacy does constrain our ability and Image: Walgreen Boots Alliance speed to react to some of the new government proposals,” says Estelle Dessiaume, Head of Business Development & Innovation at Bayer. MHRA approvals for packaging changes can take five years, with extensive testing for safety, efficacy and possible chemical interactions between packaging and product. “This isn’t something one company can do alone, especially as these products serve global markets and each regulator has its own approach. We need to collaborate as a sector,” says a major player. Moving from PVC blister packs will not be easy. Addressing recyclability via in-store collections, currently piloting in some Superdrug and Boots stores, could channel blister packs through specialist reprocessing as an alternative. Small packs get lost in MRF processing and PVC is not recycled in the UK.

The Plastics Tax, starting in April 2022, exempts licensed medicines but supplements and cosmetics are caught. Competing with groceries brands for food contact grade post-consumer recyclate means the 30% requirement may not be achieved in the short term. Switching materials, easier than for pharma, introduces other challenges. “We could switch back to aluminium tubes for creams and ointments, but they’re more likely to split and what about the carbon footprint?” “Customer enquiries on healthcare packaging remain high,” says a major healthcare retailer, adding, “Packaging has a very different function in cosmetics, often requiring more of a luxury feel.” But for Generation Z, company ethics, ingredient sourcing and packaging also increasingly influence purchasing behaviours. Boots is piloting cosmetic packaging take-back, proving popular with customers rewarded via their Advantage cards. “The Boots and No7 recycling scheme introduced in September 2020 recycled over one tonne of plastic in just under two months. In that period, we saw over 30,000 customers signing up and they’ve recycled over 100,000 empty products,” says Andrew Jenkins, Product Sustainability Manager, No7. Sustainable packaging is firmly on the agenda for pharma and healthcare, but it’s not just about avoiding plastics or ensuring recyclability. “You’ve got to think about what’s in the packaging too. You may have to compromise if that delivers bigger sustainability wins overall – and communicate that to the public.”

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Reducing waste and errors By Nathalie Wardé Dunoyer, D4Ppharma

Unit dose dispensing is a potential answer to demands for less waste and a means to avoid medication errors. he healthcare sector is at risk with significant losses caused by avoidable errors. An alarming report published by McKinsey records US$ 50–100 billion lost due to improper administration of drugs in hospitals only, US$ 18–115 billion lost because of follow-up of medication errors, such as longer stay hospitals, disabilities, deaths, and more than 100,000 deaths annually, meaning that patients could be at risk of suffering avoidable harm from healthcare. On the top of this, in our globalised world, medicinal products are manufactured and distributed in complex supply chains. Effective oversight of the supply chain is weakened, raising the risk of falsified medicines entering the market and increasing inefficiencies such as stockouts or expired products. This can lead to a loss of public confidence, which eventually results in reduced adherence to treatment. Supply chain risks and errors are inevitable, so the challenge is to reduce the frequency and impact of such events..

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Regulatory guidance Regulators, such as the WHO, EDQM and national agencies all around the world, provide guidance to develop and implement tools to reduce risk and improve safety. More than 80% of countries have implemented regulations on the traceability of medical products in an attempt to fight falsification.

all healthcare professionals to educate patients on ways to reduce waste, and lowering the risk of accumulation of unused medicines. In this context in France, a law dated February 10, 2020, indicates that the dispensing of certain drugs at the pharmacy could be done by unit as of January 2022.

The fight against waste and the circular economy could also lead to another positive impact in reducing the risk of medication errors. In the context of making Europe climate neutral in 2050, the European Commission published a set of policies, known as The European Green Deal. This impacts the healthcare sector in many ways; reviewing measures to address pollution from large industrial installations, involving

A recent report published by the French Academy of Pharmacy describes the current dispensing methods in hospitals or in pharmacies within the framework of Multi Dose Dispensing (MDD), mainly for establishment for dependent elderly persons. The report aims to be objective and does not really take a position. However, it recalls the regulatory framework in force in France for dispensing and underlines

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the risks that the necessary adaptations to this type of practice will generate for all actors in the drug distribution chain, including manufacturers. Two other European countries (the Netherlands and Norway) mentioned in this report have moved towards this model. Two cantons in Switzerland have also recently organised trials of delivery by unit and a report on the latest trial in Neuchâtel canton is due to be published soon. It should

be noted that, contrary to France where MDD, although more and more practiced by pharmacists, still has no regulatory framework, the regulation in Switzerland covers the activities of preparation of unit doses: (1) on the one hand by the Swiss Pharmacopoeia and its monograph on the manufacture of small quantities of medicines. This regulation constitutes the basic reference for inspections by cantonal pharmacists; (2) on the other hand, by the GMP (Good Manufacturing Practices) for automated manufacturing. This activity can be subcontracted to manufacturers with an operating licence for the manufacture of medicinal products, and therefore under the responsibility of a Qualified Person (QP). The European Pharmacopoeia reference for the manufacture of Automated Dose Dispensing (ADD) completes this regulatory picture.

This particular distribution method will remain under pharmaceutical responsibility. Waste and traceability gains Unit dose dispensing can also reduce the risk of errors in the administration of medicines and at in-take by the patients, which contributes to better therapeutic adherence, particularly in the case of complex treatments. It is therefore highly likely that, in the context of waste prevention, but also in the context of treatment monitoring to improve compliance, the distribution of individual drugs will be facilitated in the coming years, particularly for certain treatments (especially the most expensive and the most sensitive to therapeutic monitoring). Thus, the identification and traceability of these doses becomes imperative. Traceability technologies, such as the use of 2D barcodes, are available today offering the possibility to trace medical products along the supply chain from final stage manufacture until its administration or even until patient intake. All the players in the chain – drug manufacturers, suppliers of automated dose manufacturing equipment and manual dose preparers – will have to agree to identify these unit doses in a simple and standardised way, in order to help dispensing pharmacists to exercise their pharmaceutical responsibility towards patients and to help better manage them. Definitely, the European Green Deal principle of “do no harm” will continue to resonate strongly with healthcare professionals everywhere.

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or contract packers and manufacturers, managing the day-to-day shop floor is no easy task. Relying on manual processes for managing the various, complex areas of their operation – from production tracking to profitability analysis to quality control – poses constant risks for costly errors and wasted personnel hours. Co-packers and contract manufacturers often put up with these time-consuming processes, unaware that these inefficiencies are stifling their ability to grow as businesses. Luckily, the solution to this dilemma already exists. By utilising purpose-built software platforms to digitalise shop floor operations and replace obsolete, manual workflows, contract suppliers gain the freedom and flexibility to pursue more profitable growth opportunities. Here are three specific areas where software can relieve production floor issues for contract packers and manufacturers: Traceability It has become much more common for fast-moving consumer goods (FMCG) brand customers to expect their contract supplier partners to have a digital solution in place in order to track and trace lots in real time throughout the production process. Manually tracking lot codes is an antiquated solution that can no longer keep up with

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Adapting to new trends By Emma Verkaik, Membership & Marketing Director of the BCMPA

Outsourcing partners are delivering for the latest pharmaceutical and healthcare packaging demands. he requirement from brand owners and retailers alike for innovation, security and sustainability in packaging from the pharmaceutical and healthcare sector has always been strong, but recent changes in enduser demands and the impact of the COVID pandemic have accelerated this push across the industry.

“With the growth in demand for home delivery, especially in the sectors of vitamins and food supplements, we’re focusing on expanding our capacity for the production of protective, single dose sachets and blister packs, as well as developing alternative formulations such as powders, to meet our clients’ requirements for convenient and postable products.”

Changing retail The exponential increase in home delivery, exacerbated by the closure of high street outlets, lockdowns and the increase in numbers working from home, has been sector wide. This has led to strong demand from retailers for a rapid recalibration from BCMPA members in how to satisfy their exact requirements, including products like sachet/ single dose packaging, and the development of letterbox-friendly packaging solutions, to provide lightweight, economical, and easily distributable products at scale. Clare Campbell, Managing Director of Vitrition, comments,

Supply chain resilience The urgent need for the production and despatch of millions of COVID test kits further added to the workload of contract manufacturers, packers and third-party fulfilment, with increased demand placing strain on packaging, raw materials and in-house labour. Additionally, several members have engaged in discussions with clients in respect of longer term forecasted volume requirements, to facilitate contingency planning. The establishment of contingent stock holding and alternative supply chain partners has been key for members in maintaining

Like us, many firms in our industry are now following a ‘dual sourcing’ approach, with back-up suppliers throughout their supply chain. production and delivery targets, and the recent Brexit departure has led to many sourcing UKbased supply options wherever possible. “Like us, many firms in our industry are now following a ‘dual sourcing’ approach, with back-up suppliers throughout their supply chain,” confirms Gareth Lewis, Managing Director of PharmaPac. “This is especially important with high value, long lead time products and packaging items.” Innovation and accountability The process of innovation in packaging is complex, as it must address several disparate areas of development, from convenience, economy and efficacy to security,

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sustainability and brand fidelity. Recent changes in packaging needs have put innovation at the forefront of members’ strategic planning, focusing on the need for the trialling of different packaging materials, enhanced patient engagement and security. Increasingly, new areas of product development are also being explored, including in-house design services for clients, and the use of 3D digital printing to produce bespoke solutions in days, rather than months, as had previously been the case. This level of service may soon become the norm in the sector, says Ian Robinson, Business Development Director at Chester Medical, “Our sister company, Addition Design, has seen significant growth in enquiries over the last 18 months from clients seeking to develop innovative, cost-effective and speedy solutions to their packaging development, as they adapt to the changing needs of the industry.” Alongside the strict operational demands of producing pharmaceuticals within MHRA guidelines, some members are seeing much greater demand for track & trace on packaging to meet the demands of the latest global legislation. The growth in ensuring these sophisticated requirements, particularly for Russia, and the need to increase the ability (across the supply chain) to identify counterfeit products more easily, has seen businesses enhance their capabilities and capacity greatly in the last year to meet the requirements of their clients. Interactive packaging Allied to the drive towards enhanced security and safety in packaging, is the use of

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smart packaging. Also known as interactive packaging, intelligent packaging, or simply active packaging, this innovative approach adds another dimension of functionality, enabling the packs themselves to provide information about their contents through codes and reader technology.

on recycling by consumers as the ideal sustainability solution needs improved education and communication, particularly concerning materials that have been in contact with certain products and have been crosscontaminated, and which are then no longer suitable for recycling.

This in turn contributes to improved patient adherence and engagement and confidence in the authenticity of the product and its packaging. Several approaches can be taken, with the use of holograms and smart inks being amongst the most common.

Bright future Whilst supply chain challenges and the impact of Brexit remain significant and testing for our industry, and the relaxation of COVID restrictions potentially impacting on the buoyancy of the home delivery sector, the agility and adaptability shown by BCMPA members to serve the fast-changing needs of pharmaceutical and healthcare clients, bodes well for the maintenance of recent growth.

Smart packaging is particularly effective for more complex medical devices, providing more intuitive opening instructions. Chester Medical’s Ian Robinson highlights this, adding that, “It is particularly valuable in the area of products for surgical use, where it can indicate the correct order of opening during operating procedures.” Sustainability matters With sustainability and green credentials becoming of increasing importance for many types of packaging, members are building it into the very early stages of new product development, finding it easier to deliver effective results from new designs, rather than the ‘retro adaptation’ of existing lines. Progress is being made in several other areas, including reducing tray weights, sourcing of new more sustainable materials, and maximising fill sizes. Regarding the delicate question of plastics, still seen in a negative light by many consumers, there is widespread consensus that the removal of this material from the process entirely will be challenging. It was also felt that the focus

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The future is viewed with unanimous positivity. Clare Campbell of Vitrition concludes, “There is an acceptance from clients and manufacturers alike that packaging needs will continue to change, and an increasing number of suppliers are supporting this. Working together, I believe that collaboration and investment in new technology will provide many of the answers we seek.”


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Ready for all eventualities By Andy Knaggs, Journalist

The COVID pandemic, sustainability and personalised medicine are all profoundly affecting the pharmaceutical and healthcare sectors. How are they impacting packaging manufacturers serving these sectors and what answers are there from machinery suppliers? harmaceutical products, and the ways in which they are distributed and administered, have been under the microscope like never before in the last year or so. There is no real hyperbole in saying that the entire world has become obsessed with vaccinations, as images of small bottles and vials have flashed across everyone’s TV screens. COVID-19 has obviously had a massive impact on parts of the pharmaceutical sector – but has it had a similarly big impact for packagers serving the pharma market? Yes, according to Miriam Krechlok, pharma specialist at Mettler Toledo Product Inspection, who says, “We are currently facing a trend of rising demand for liquid medication. Sterile liquids are

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currently enjoying the strongest market growth, driven by the rising importance of biological products such as vaccines and oncological drugs. This means that there will be more demand for small and fragile containers like bottles, vials and ampules – all unstable on conveyors – as primary packaging.” For packaging manufacturers, meeting this trend requires new ways of handling these fragile products, which may or may not be possible with their existing production lines. “Pharmaceutical manufacturers may have to rethink their whole production process,” she continues. “In terms of product inspection solutions, they have to carry out detection of under- and overfilling, precision weighing for product completeness, track & trace solutions, and contamination detection. There are challenges to face with the integration of new equipment, high accuracy at production speed and, as mentioned before, effective product handling to maximise uptime.”

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The response to the pandemic has caused changes in other areas of pharmaceutical and healthcare packaging, says Timo Kollman, managing director of film and paper packaging machine manufacturer Hugo Beck. Demand has been high, he says, for safe and hygienic packaging of products such as PPE, pipette boxes, and components such as microfilters, used in the production processes of vaccines and pharmaceutical liquids. “Flowpack packaging or classic poly bag and shrink packaging are widely used for all these applications. Where a hermetic seal and high-barrier packaging is a pre-requisite to ensure the hygiene of the final product, flowpack machines are ideal. They are designed to be extremely flexible to cope with the many different product sizes and bundles, and our equipment is designed to conform to the highest demands for documentation and certification/validation, whilst providing absolute traceability throughout the process,” says Kollman.


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Growing trends So all-encompassing has the COVID crisis become that it might be easy to forget about other trends in the packaging market that pre-date the virus. They are still there, however, and in the case of sustainability, growing strongly. This has been observed by Yorkshire Packaging Systems (YPS), whose managing director Glyn Johnson relates the experience of one of its customers, Health Innovations. This company produces cartons and tubs of nutritional supplements and vitamins, supplying chemists and supermarkets across the UK. It reported that many of its pharmaceutical clients were requesting packs without cardboard trays, in order to satisfy eco-conscious consumers. Health Innovations had purchased a side-feed sleeving machine from YPS, and this proved ideal, says Johnson, “It can create both trayed and tray-less packs, while maintaining complete stability, even for stacked products. Using a pack clamp and upgraded steel mesh belts, the items transition smoothly through the line maintaining their collations and position even without a cardboard insert or tray. “Removing trays is a popular trend in this field, as it reduces the overall volume and weight of packaging per pack and minimises costs. It is also a simpler and faster solution compared to a cardboard tray which needs to be erected and inserted prior to the shrinking stage.” Italian manufacturer Sacmi also reports more urgency creeping into the environmental credentials of packaging for pharmaceuticals. This is becoming apparent in areas such as reduced pack sizes, reduced plastic content and increased use of recycled

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and recyclable materials. The company’s containers director Ivan Bonzi claims Sacmi has been a pioneer in lightweighting plastic containers for pharma,

towards customised solutions, saying that ever-greater product variation in pharmaceutical packaging requires responsive, high-speed batch production systems, with increasingly accurate and consistent sensors acting as the “eyes and ears of the process”. Not only do these enable tasks such as picking, placing, labelling and code-reading possible at high-speed, they also make job changeovers much quicker, reducing downtime and wastage.

adding, “Compression blow forming technology is a powerful tool to achieve new sustainability standards in pharmaceutical containers, with no compromises with barrier properties and safety.” Hugo Beck’s Timo Kollmann says the urgency and awareness in the pharma packaging industry around issues of sustainability is increasing significantly, going “beyond mere talking”. More and more initiatives are seeking to reduce plastic use, he says.

For the future, Mettler Toledo’s Miriam Krechlok sees the “coming revolution” of personalised medicine having a huge impact on pharmaceutical companies, bringing them a myriad of new challenges. “This trend and the need for smaller batches requires filling lines that are smaller, more modular, flexible, and with shorter lead times by being fully compliant with GMP (Good Manufacturing Practice) guidelines. This will of course not only affect the drug manufacturers: it has an impact for the whole supply chain. Therefore, our R&D departments are working closely together with our customers and partners along the pharma production chain to understand the upcoming needs even better and derive the right solutions.”

Custom machines and medicines Beyond the environmental imperative, Kollmann also identifies the demand for customised packaging machine designs as another growth factor. “In general, we are dealing with highly customised machine designs in the pharmaceutical and medical technology sectors, from meeting requirements in terms of cleanroom hygiene, documentation and safety through to enabling complete traceability. We would expect this growth in more customised solutions to continue, alongside growth in automation, with the use of robotic systems as part of the packaging line.” SICK UK, the inspection system manufacturer, backs up this trend

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It is a sentiment that packagers will be cheered to read, as they navigate through times of unprecedented change.


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22 & 23 September 2021 | Olympia, London

Join us at the capital’s most innovative packaging event “The show has been the perfect opportunity to speak to our current suppliers and see what they are doing, as well as scout out potential new suppliers. As a brand, we are increasingly looking for sustainable options, so the show has been great to see what’s out there.” Rhiannon Street, Junior Packaging Designer, Molton Brown

“There’s always a great mix of products and seminars that are industry specific addressing key trends! It’s perfect that topics are discussed from several different angles, as you get a better idea of the issues at hand.” Manuela Stadelmann & Ellea, Head of Marketing, Penhaligon’s

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