EUROPEAN EDITION
MEDICAL PLASTICS news + EUROPEAN SALES DIRECTOR AT TEQ ANNE-SOPHIE BELAMINE SALIENT BIO CO-FOUNDER JACK PRIESTMAN ON TESTING FOR HIGH-CONTACT INDUSTRIES ANDALTEC’S EXPERTISE IN CREATING A NEW PORTABLE MEDICAL DEVICE
TridAnt INFECTION PROTECTION THE HYGIENE OF THE FUTURE BRINGS BACK ‘PHOELINGS’ OF THE PAST
ISSUE 58
Jan - Feb 2021
WWW.MEDICALPLASTICSNEWS.COM
for medical devices, pharmaceutical manufacturing and digital health. Keep up to date with key developments that matter.
AVAILABLE IN PRINT, ONLINE AND DIGITAL FORMATS
ADVANCING HEALTHCARE
CONNECTING PHARMA
Advancing Medical Plastics
Intelligence for professionals involved in the design and production of Class I, II & III medical devices
Intelligence for the pharma and biopharma manufacturing supply chain – from clinical trial to mass production, regulations, and logistics and distribution
The essential information source for anyone involved in the design, manufacture and supply of plastic medical devices
www.med-technews.com @medtechonline
www.epmmagazine.com @EPM_Magazine
www.medicalplasticsnews.com @MPN_Magazine
CONTENTS January/ February 2021, Issue 58
Regulars
Features
5 Comment Rob Coker introduces the first 2021 edition of Medical Plastics News.
11 Coat of arms Addmaster CEO Paul Morris speaks to MPN about his company’s efforts to make the world a safer place.
6 Digital spy 12 Cover story Arjun Luthra, Commercial Director, BioInteractions, explains how multi-action technology is a straightforward solution to COVID-19, a preventative measure for future pandemics, and a boost to global healthcare infrastructure. 26 02:2021
16 Big strides in small batch aseptic processing Cindy L’Esperance discusses the continuing benefits of technology in the life sciences sector. 18 High-contact industries: Why we still need testing Salient Bio Co-Founder Jack Priestman discusses recent healthcare challenges, and the need for consistent solutions. 23 Quick and clean Connect 2 Cleanrooms expedited the design and build of a temporary medicines unit for NHS Wales. 24 A design for life Andaltec’s expertise helped a Madrid-based nurse develop an easy-to-use syringe container.
WWW.MEDICALPLASTICSNEWS.COM
3
You expect precision. We deliver. contract manufacturing injection moulding medical devices Our manufacturing includes cleanroom environments, automation, and assembly services, delivering total value solutions that reduce investment and improve cost.
www.carclo-ctp.co.uk +44 208 685 0500 sales@carclo-usa.com United States
• United Kingdom
• Czech Republic • India
• China
editor | rob coker robert.coker@rapidnews.com advertising | caroline jackson caroline.jackson@rapidnews.com vp sales & sales talent | julie balmforth julie.balmforth@rapidnews.com head of studio & production | sam hamlyn
Editor’s Comment
graphic designer | matt clarke
ROB COKER
junior designer | ellie gaskell publisher | duncan wood Medical Plastics News Europe Print Subscription – Qualifying Criteria UK & Europe – Free US/Canada – £249 ROW – £249 Medical Plastics News NA Print Subscription – Qualifying Criteria US/Canada – Free UK & Europe – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074
© 2021 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)
New beginnings A whole year in – give or take – and another month in lockdown comes and goes. So let’s break up the fatigue with some positive news from the world of healthcarebased plastics to try and get this year off to more optimistic start. My colleagues from Interplas, the UK’s largest plastics trade fair, are bringing back the popular MediPlas Conference, where experts will gather to discuss the roles that plastics in the healthcare industry have played – and continue to play – in holding back this insipid pandemic. Whether your field is in packaging for medical devices, drug delivery systems, or materials for PPE, you are of course invited to join and lead the discussions by getting in touch with the organisers through the Interplas Linked In and Twitter pages. We will be delighted to hear from you. In other good news, packaging, as a result of the events of the past year or so, is no longer universally scorned as the bane of the environment – and not merely because of its inherent hygiene qualities. Entrepreneurs and wellestablished recycling specialists have more than raised the bar when it comes to the quantity and quality of recycling initiatives. UK-based Cromwell Polythene, for example, has strengthened its UK recycling and manufacturing operations, to help businesses protect themselves and the environment during the pandemic by investing in new machinery and upgrades at its manufacturing and recycling site.
WWW.MEDICALPLASTICSNEWS.COM
Furthermore, VinylPlus recently unveiled a new collaborative project called VinylPlus Med that aims to accelerate sustainability in healthcare across Europe by recycling single-use PVC medical devices. Within this edition, you will find more on packaging from TEQ’s Anne-Sophie Belamine, who takes a look at the trends for 2021 in our industry Forecast feature. And I spoke with Addmaster CEO Paul Morris about his royal recognition for work in the UK coatings industry, which includes antimicrobial technology utilised in shopping trolley handles. And Spain-based Andaltec have used their expertise to help a Madrid-based nurse develop a unique medical aid that helps HCAs and professionals keep two hands free when administering emergency medicine. Ongoing political sea changes notwithstanding, there is much to look forward to this year: returning to the office being one; returning to personal appearances at international trade fairs being another. Get yourself a drink, put your feet up, and take a break with this, the first edition of Medical Plastics News Europe of a whole new year.
5
DIGITAL SPY
DIGITAL
spy
M
www.sanitized.com
SANITIZED BROADTECT PROTECTS POLYMERS AGAINST A WIDE RANGE OF MICRO-ORGANISMS his newly developed product by Sanitized AG has high temperature resistance and is suitable for thermoplastic processing methods such as extrusion processes or injection moulding. The new Sanitized product from the BroadTect portfolio features durable antimicrobial protection that is effective even after weathering. In addition, good antiviral efficacy on surfaces has been demonstrated. This temperature-resistant, antimicrobial product is suitable for most
www.medneteurope.com/en
MEDNET EXTENDS TUBING PORTFOLIO
MATERIALS UPDATE
T
NEWS UPDATE
thermoplastic polymers such as PE, PP, TPU, EVA, PVC, rubber (EPDM, NBR, SBR) that are used in the extrusion process or in injection moulding. It is compatible with commonly used additives, making it usable for an abundance of applications. Christine Niklas, Product Manager, said: “With the new product for polymers, we offer the polymer industry an innovative, versatile, multi-protection product that ensures comprehensive, durable antimicrobial protection from any microorganisms.”
edNet, a Germany-based supplier and manufacturer of medical and pharmaceutical components, has expanded its comprehensive portfolio of tubing with additional materials and configurations. As well as an increased range of tube sizes, the portfolio now covers materials including silicone, PU/ PUR, Acrolene XP (a flexible TPE), LLDPE/PE, and PVC. The material selection allows designers to manage key mechanical and chemical
RECYCLING UPDATE
www.cromwellpolythene.co.uk
Cromwell Polythene invests in UK manufacturing and recycling operations
C
romwell Polythene continues to strengthen its UK recycling and manufacturing operations, to help businesses protect themselves and the environment during the pandemic. Investment has been made in new machinery and upgrades to existing machines at its UK manufacturing and recycling site, CPR Manufacturing. This has improved processes and increased energy efficiency to help meet the Climate Change Agreement obligations, as well as increasing capacity for film extrusion and bag making, in recycled and virgin polythene. MD James Lee said: “Our comprehensive range of products
6
properties ranging from shore hardness, flexibility over kink and temperature resistance to bondability. Medical grades can be DEHP or plasticiser free and are suitable for a range of sterilisation procedures. The MedNet tubing as well as various other unsterile components for medical and industrial applications can be found in MedNet‘s online catalog under www.medneteurope.com/ components.
WWW.MEDICALPLASTICSNEWS.COM
is designed to prompt responsible waste disposable and recycling behaviour, whilst helping to keep people safe and minimise infection risk.”
DIGITAL SPY
RECYCLING UPDATE
vinylplus.eu/community/vinylplus-med
VinylPlus Med accelerates sustainability in healthcare
V
inylPlus has unveiled a new collaborative project called VinylPlus Med that aims to accelerate sustainability in healthcare across Europe through the recycling of discarded single-use PVC medical devices. Adequate sorting and recycling of noninfectious plastic waste can significantly reduce the environmental impact of hospitals and their operational costs.
talking
POINT
The scheme will focus on clean and REACH-compliant PVC waste that can be recycled into a wide range of value products marketed across Europe. Brigitte Dero, Managing Director of VinylPlus, said: “Starting with a pilot project in Belgium, we are excited to make medical plastics more circular together with our partners.”
www.freudenberg.com/ careers/freudenberg-medical
SVEN ROSENBEIGER, VICE PRESIDENT AND GENERAL MANAGER, GBU THERMOPLASTICS, FREUDENBURG MEDICAL.
APPROVAL UPDATE
www.cardiacsense.com
CardiacSense medical grade watch receives CE Mark for continuous detection of atrial fibrillation
C
ardiacSense has received the CE Mark for marketing and sales of the device in the European Union. The indications certified include ‘detection of Atrial Fibrillation (AFib)’ and ‘monitoring of Heart Rate Variability (HRV)’ with continuous Photoplethysmography (PPG) and spot Electrocardiogram (ECG). Data from two clinical trials reviewed for the CE Mark demonstrated accurate detection of A-Fib by continuous PPG of over 99 per cent. The company has launched clinical trials to receive regulatory certification for additional vital signs including continuous respiratory rate, core temperature, oxygen saturation, blood pressure, and other arrhythmias.
CEO and Co-Founder Eldad Shemesh said: “CardiacSense is the first and only company to receive CE Mark certification for continuous PPG wristbased monitoring at the individual heart beat level and arrhythmias detection, a milestone that will enable us to implement the distribution agreements we have signed in 15 countries.”
Tell us a little bit about the history of the company. Freudenberg Medical is a contract manufacturer of medical components and minimally invasive device solutions with 11 locations worldwide. The Baldwin Park, California, operation was established in 1997 and is focused on medical thermoplastics with 72,000 sq.ft., three ISO Class 8 cleanrooms, two assembly rooms, a metrology lab, and advanced automation and in-line vision systems. What does the recent expansion mean for Freudenberg in terms of getting muchneeded medical devices to market quickly? Dedicated machines for high volume demand and 24/7 production. How does the machinery/software help to maintain strict quality standards? New machines are able to keep tighter tolerances and process parameters. The Battenfeld machine has integrated equipment for in-process visual inspection capability to ensure quality. Which machinery manufacturers are involved in the partnership? Machinery from ARBURG and from Wittmann Battenfeld were selected for this ongoing project. Which end markets are these products destined for? Our recent expansion of injection molding technology supports the manufacture of diagnostic test kits including covid-19 test kits and analyzer products for the in-vitro diagnostic market.
7
INDUSTRY FORECAST
REASONS WHY TEQPROPYLENE WORKS FOR EVERY MEDICAL PACKAGING PROJECT EUROPEAN SALES DIRECTOR AT TEQ ANNE-SOPHIE BELAMINE LISTS THE 2021 TRENDS IN MEDICAL PACKAGING REQUIREMENTS, AND WHY TEQ PROVIDES THE RIGHT SOLUTION FOR ANY PROJECT.
F
or many years, PETG has been the ‘go-to’ material of choice for medical packaging for its clarity and sterilizing capabilities. However, with the ever-growing concern for recyclability and the California Legislation AB 906 changing the recycling classification of PETG, consumers have been looking for alternate materials to produce their packaging. Polypropylene has emerged as a great alternative material, and TEQ offers a unique blend of polypropylene as a packaging solution. TEQpropylene, or ‘TEQp’ for short, is comparable to PETG in many ways. Here are the top 10 reasons why packaging suppliers should switch to TEQp for your next packaging project. COST SAVINGS Compared to PETG, TEQp has a 30 per cent cost savings, making it a much more cost-effective material to use for most projects. LIGHTWEIGHT TEQp is the lightest of all of TEQ polymers, resulting in a lighter, thinner but stronger finished package. VERSATILE TEMPERATURE RANGE TEQp can be put through a microwave, freezer and anything in between without compromising the quality of the package. ELASTICITY AND TOUGHNESS According to design engineering consultants Creative Mechanisms, ‘Polypropylene will act with elasticity over a certain range of deflection (like all materials), but it will also experience plastic deformation early on in the deformation process, so it is generally considered a “tough” material. Toughness is an engineering term which is defined as a material’s ability to deform (plastically, not elastically) without breaking.’ CLARITY TEQp has a clarifying additive that makes this material comparable to PETG, so packaging manufacturers can take advantage of all of the qualities of PP without compromising on clarity. STERILISABLE Studies show that polypropylene can be sterilised with EtO, EBeam, Gamma (with additives to stabilize the material), and some autoclave, making it highly suited to medical packaging. For a closer look at what materials stand up to different sterilising methods, Industrial Specialties Mfg and IS MED has produced this definitive article.
Studies show that polypropylene can be sterilised with EtO, EBeam, Gamma, and some autoclave, making it highly suited to medical packaging
SEALABILITY TEQp can become a complete sterile barrier system package when sealed a DuPont Tyvek lid. No sterility is compromised by switching materials. POPULARITY Polypropylene continues to rise in popularity with research showing that end users are buying more and more polypropylene for their packaging products because of its functional, durable, and clear properties. SUSTAINABILITY Not only does TEQp produce lower fuel consumption and lower emissions, but it also results in less solid waste by weight than PET, PS, or PVC. Brand owners including Starbucks and McDonald’s have switched to the use of polypropylene in cold cups rather than PET, as it uses less plastic and lowers greenhouse gas emissions. RECYCLABILITY TEQp can be 100 per cent recycled as per the United States FTC guidelines.
9
OPINION
Watch this space CEO OF PHYSIQ GARY CONKRIGHT DISCUSSES THE SUCCESS OF ITS COLLABORATIVE STUDY ALONGSIDE PURDUE UNIVERSITY AND THE FUTURE OF WEARABLES.
If successful, this study could enable wearable devices to slow or stop the infection rates of COVID-19. What would this mean for the wearable devices/biometrics industries? Wearable biosensors provide rich 24/7 physiological data, but AI like physIQ’s is needed to turn all of that data into real insight. The objective is to identify the earliest signs of decompensation that results from a COVID infection, thus the funding by the National Institutes of Health to support our development of the CDI, or COVID Decompensation Index. Early detection using the data available from the Samsung Galaxy Watch could translate into early clinical intervention, reduced hospital admissions, less intubations and less deaths for this pandemic, and in the future. Enabling proactive medicine, replacing the reactive medicine approach that is currently in place, is the promise of digital medicine. WHICH VARIABLES COULD INHIBIT THE SUCCESS OF THE STUDY? We have conducted many studies like this using the Samsung Galaxy watch and are very confident that our collaboration with Purdue will also be successful. Purdue is already at the 30 per cent mark for their enrollment and so far, the data collection and response from those who participated in the study is excellent. WHAT WOULD MAKE SUCH A WEARABLE DEVICE MORE APPEALING THAN PERHAPS DOWNLOADING A TRACK AND TRACE APP, FOR EXAMPLE? These are two very different use cases. The work we are doing with Purdue University is around enabling early detection, which most physicians and researchers believe is the key to better clinical outcomes. Track and trace seeks to minimize the spread of infection to others once a person becomes infected. However, there may be benefit to earlier detection for an infected patient, to get them into isolation sooner, thus reducing the possibility of transmission.
FINALLY, WHAT WOULD YOU SAY TO THOSE WHO REMAIN SCEPTICAL ABOUT PERSONAL DATA COLLECTION OF THIS KIND? It is the new frontier of digital health. More and more wearable devices are becoming available, and people want to take their health into their own hands. Especially in this current COVID-19 world, not everyone wants to go to the doctor or hospital anymore and risk exposure to the virus. By combining this personal data collection and personalized data analysis that is only available from leveraging the power of AI, with a world class university, we can work together to beat this virus and get students, faculty and staff back to campus safely.
HOW DOES AN INDUSTRY PLAYER GO ABOUT GAINING CORROBORATION FROM A CLINICIAN OR OTHER HEALTHCARE PROFESSIONAL? The demands for clinical research have always been high for any disease, but particularly so for COVID-19. When a researcher looks to partner with a firm like physIQ, they look for expertise in the practice of clinical studies and a commitment to meeting or exceeding the demands of various regulatory bodies. PhysIQ has a proven track record and evidence, such as our 5 FDA clearances, that provides the confidence that healthcare professionals need.
10
WWW.MEDICALPLASTICSNEWS.COM
COATINGS
COAT OF ARMS ADDMASTER CEO PAUL MORRIS RECENTLY RECEIVED ROYAL RECOGNITION FOR HIS WORK IN THE UK COATINGS INDUSTRY. HERE HE SPEAKS TO MPN ABOUT HIS COMPANY’S EFFORTS TO MAKE THE WORLD A SAFER PLACE.
Tell us how Addmaster has helped take some of the strain away from medical and healthcare professionals over the course of the COVID-19 pandemic? It would be unfair to say we have taken the strain, as medical professionals are physically on the frontline risking their lives every day. What we have done is remained operational throughout the pandemic, supporting our clients to offer products and surfaces that boast improved hygiene and, through Biomaster, prevent bacteria and viruses from growing on them. Much of this has been a fast-track process and this has been a complex challenge, with Addmaster staff socially distancing or working from home. We have overcome it, but it has required an enormous amount of hard work and dedication to the cause. Which markets are the company’s products best suited to serve and why? With regards to Addmaster, I would have to say every market as we can be found in everything from a Dyson Airblade (antibacterial) to expensive sports equipment (anticounterfeit) to eco-friendly ground membranes (oil digestion). Our most well-known technology is Biomaster and this antimicrobial/ antiviral technology can be found across all product areas and in all corners of the globe
However, the strength of the product offering and our close relationship with EU partners has enabled us to ride the rough seas the Brexit negotiations brought. This has been further reinforced with Addmaster becoming part of the Sweden-owned Polygiene group as part of a multimillion pound deal. The acquisition brings together our expertise in antimicrobial technologies on hard surfaces with the parent group’s longstanding reputation in odour control and antiviral solutions for textiles. On a wider note, the UK will continue to be seen as a centre of excellence for innovations and entrepreneurialism, and now we at least know the way forward with the Brexit deal finally passing. It’s time to focus on those qualities again.
This means that Biomaster can give up to 99 per cent protection just four hours after it has been added to products, preventing any bacteria or virus growing on everyday items.
Finally, what does royal recognition of your services mean to you personally, as well as professionally? Personally, I never believed that I would get recognised in such a way, so it’s a huge honour for me. It’s a bit of a cliché, but the Addmaster team are the ones that have earned it though, as what they have done in the last 20 years is phenomenal and no person can do it on their own. In short, I owe this award to them and my amazing family for supporting me on the journey.
How can UK-based expertise such as yours help remind your European clients and counterparts that Britain remains at the forefront of industry, as well as innovation? Brexit has not helped at all with any EU relationships, which is why most businesses were firmly on the ‘Remain’ side of the debate. Even in its most basic repercussion, we know European clients tried to find alternatives to our technology to avoid tariffs (and why wouldn’t they?) and we all know the danger of our customers talking to competitors.
Professionally, I know many people thought I was crazy when I had the idea to create Addmaster on a platform of licensed toll manufacturing, so I could spend more time on R&D with clients. So for me, it is tremendously rewarding to get this honour on top of all the success that Addmaster has enjoyed – and to confirm that, in this short life we have, you have to follow your dreams, not the flock.
Which materials are they best suited to treat? If we are focussing on Biomaster then the technology can be applied on porous surfaces (textiles and paper) and polymers, coatings and paints. The range has been developed over the last 20 years to be market-leading technology and has led the way with SARS-CoV-2 testing (the virus that causes Covid-19).
WWW.MEDICALPLASTICSNEWS.COM
11
COVER STORY
TridAnt INFECTION PROTECTION ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS, EXPLAINS HOW MULTI-ACTION TECHNOLOGY IS A STRAIGHTFORWARD SOLUTION TO FIGHT COVID-19, PREVENT FUTURE PANDEMICS AND ENHANCE GLOBAL HEALTHCARE INFRASTRUCTURE.
T
he case for revolutionary technologies and solutions that greatly enhance our quality of living has never been more important than now. Innovations that protect and enhance our daily routines are in constant demand, and are especially critical considering the COVID-19 pandemic. As the pandemic has persisted, our healthcare services and innovations have battled to keep up with viral mutations, as well as mitigate impact to other areas of healthcare. This highlights the importance of a preventative measure to be in place so we can all return to a better normal. Such a prevention measure must focus on confronting the current COVID-19 vaccine, preventing mutated versions of the pathogen, and enhancing global infrastructure to prevent another pandemic from occurring. THE ROLE OF MATERIALS Materials play a critical role in improving the performance of technology and can improve the applicability of the products. The antimicrobial efficacy of materials
involves critical interactions between the pathogen and surface interface, and the successes of applications are dependent on a variety of biological events occurring at this interface. These events intensify the complications, which must be addressed during the innovation and development stages. The challenge of infection prevention will help long-term prevention mechanisms on medical devices as well as consumer applications. The biological events which occur at the pathogen-surface interface is critical to improving the prevention technology against pathogens. Biological responses are complex processes which are governed by a variety of factors. These factors range from surface properties – which include the chemistry, topography, wettability, and composition of a surface – to the biological entities present at the interface. Infections on surfaces have long been studied as these pose a significant challenge which impedes long-term medical device applications. A variety of preventative techniques used on medical devices have proven not to be significantly effective and highlight the need for an innovative solution. It has been seen in a randomised study of surface treatments to prevent infections that silver surface treatments have failed to reduce infection rates. It has also been seen that the use of silver-impregnated collagen cuffs can impede catheter fixation due to the killing of fibroblasts and cause the catheter to dislodge. Therefore, highlighting the toxic impacts of silver technology on eukaryotic cells. Furthermore, it has been recommended that any catheter which has caused bacteremia should be immediately removed and only replaced once results of blood cultures normalised. This highlights the difficulty previous technologies experienced when combatting infections safely on a surface over long periods of time. Such an approach has had limited success, requiring the use of antibiotics which leads to resistance and further complications. The biological events which occur on a surface are a complex result of interactions between the surface and the proteins and cells, which are present at the pathogen-surface interface. These complex challenges require a multi-phase material which considers all these varying factors in one straightforward technology. Multi-phase materials provide a highperformance surface which prevents pathogen growth, enhances protection durability, and uses safe components all in one straight-forward solution. THE POWER OF PARTNERSHIPS BioInteractions Ltd. and Phoel Ltd. have partnered to provide TridAnt, the world’s most advanced infection prevention infrastructure that enhances the control of pathogens in an environment. TridAnt technology ensures broad spectrum protection of up to 99.999% against bacteria, viruses and fungi as well as enhanced durability of up to 365 days – all whilst using technology proven to be safe to use on medical devices.
12
WWW.MEDICALPLASTICSNEWS.COM
COVER STORY
TridAnt Infection Prevention Infrastructure consists of: • TridAnt Shield – Protective film immediately protects all hard surfaces and kills 99.999% of bacteria, viruses, and fungi for up to 365 days whilst reducing cleaning maintenance and routines. • TridAnt PPE – PPE items enhanced to kill 99.999% of bacteria, viruses, and fungi for up to 365 days without the need to change from patient to patient whilst reducing single-use items. • TridAnt Skin Sanitiser – Sanitiser and cleansing technology protects skin for up to 48 hours and kills 99.999% of bacteria, viruses, and fungi whilst preventing transfer of host flora as well as reducing water requirements. • TridAnt Dry-wipe – Antimicrobial dry wipe kills 99.999% of bacteria, viruses, and fungi for up to 365 days without using liquids. TridAnt Infection Prevention Infrastructure is a straightforward, long-term solution to protecting surfaces, preventing transmission, and controlling pathogens. The infrastructure provides enhanced protection against a broad spectrum of bacteria, viruses and fungi on surfaces ranging from stainless steel to skin. The various products utilise TridAnt technology to enhance protection and provide further long-term benefits. TridAnt Infrastructure provide a viable method of improving hygiene and healthcare standards whilst reducing maintenance costs, as well as reliance on single-use items. The various products provide enhanced hygiene infrastructures that prevent future pathogens. Furthermore, TridAnt PPE cleans surfaces on contact, actively cleaning the environment throughout the lifetime of the products. This helps us to maintain healthy, hygienic environments and greatly reduces the costs of controlling pathogens on surfaces. PHOELING GOOD TridAnt Infection Prevention Infrastructure is the first line of defence and the missing tool to prevent and control pathogenic transmission. The use of rapid testing, as well as vaccines, requires additional support from technology to enable these areas to develop fast and effectively enough to keep up with future risks. The use of a prevention tool enables rapid testing and vaccines to use TridAnt Infection Prevention Infrastructure to gain time and create safe and effective vaccines. The additional TridAnt tool works in conjunction with rapid testing and vaccines to provide complete protection structure against COVID-19, its mutations, and the possibility of future pathogens. This complete infrastructure can be applied
safely into schools, restaurants, hotels and hospitals to enable a swift recovery and return to our normal routines. TridAnt technology utilises the hygiene of the future to bring back the good ‘phoelings’ (pronounced ‘feelings’) of the past. COVID-19 has shown us the significant damage that can be done to our existing healthcare infrastructures and services, as well as to our daily routines and public utilities when we are not proactive against these challenges. TridAnt Infection Prevention Infrastructure provides the tools to combat COVID19, as well as prevent a similar pandemic from occurring whilst enhancing healthcare infrastructure for the long-term future.
WWW.MEDICALPLASTICSNEWS.COM
13
Medical & Healthcare Polymer Solutions For when process control is critical. Matrix Medical Plastics is your polymer colour and performance additive partner. Based in the UK and operating from our purpose-built, cleanroom extrusion facility, we provide fully compliant compounding solutions for medical and healthcare applications. medical@matrix-plastics.co.uk
www.matrixplastics.co.uk
Surface Finishing
Cleanroom Particle Counters
is our DNA Mass Finishing Shot Blasting
Portables
Handhelds
AM Solutions
Continuous Monitoring Cleanroom Certification • Cleanroom Monitoring PMT (GB) Ltd. | Tel: +44 (0)1684 312950 | email: info@pmtgb.com
Rösler UK 1 Unity Grove Knowsley Business Park Prescot | Merseyside L34 9GT
W W W . M E D I C A L P LImagead_DNA_86_124_Medical_Plastics.indd ASTICSNEWS.COM 1
Tel: +44 (0)151 482 0444 Fax: +44 (0)151 482 4400 rosler-uk@rosler.com www.rosler.com
29.01.2020 16:18:28
ROBOTICS AND AUTOMATION
CAMPETELLA ROBOTIC CENTER DISCUSSES ITS EXPERTISE AND HOW IT BENEFITS THE MEDICAL AND PHARMACEUTICAL INDUSTRY.
Moulding 4.0 M
ore and more medical and pharmaceutical industries are investing in cutting-edge technology and adopting innovation 4.0 throughout their production processes. Campetella Robotic Center, a leading international company in the design and production of Cartesian robots and automation systems for the plastic injection moulding sector, has the right answer to such an impending need. Well aware of the pivotal role played by an accurate and constant market analysis, Campetella is strengthening its presence within the medical and pharmaceutical field. Campetella offers a wide range of innovative robotic solutions for medical and pharmaceutical moulding, resulting from decades of experience within industrial automation that turned the company into a successful and distinguished partner in all phases of the production process for various medical and pharmaceutical product families. The Campetella team can satisfy the most demanding requests for robotic solutions in many application fields and technologies, such as high-speed take-out, stack moulding, pick and place, packaging, boxing, palletizing, logistics and handling, while equipping them with the most advanced visual inspection systems for the quality control of the finished product. Such systems can be integrated into many types of automated cells. The most advanced ones use artificial intelligence algorithms for defects detection and classification to constantly improve quality control until perfection is achieved. An essential technology in such a demanding sector, where the finished product compliance and safety is compulsory. The production of medical and pharmaceutical goods requires the highest standards in terms of hygiene and quality, which Campetella carefully meets by constantly improving its automation systems. The new project, which the Campetella Research and Development department is recently working on, proves it. We are talking about a petri dish packaging system with bottom-up insertion capable of guaranteeing the maximum hygiene of the packaged product. A solution that allows a minimum footprint on the ground while optimizing the space by reducing the air inside the package. Among the main systems designed by the Campetella engineers, we find it interesting to mention the new stack-mould robotic solutions aimed at maximizing productivity while reducing footprint and energy consumption: • Multi-robot modular cells for petri dishes production in stack-mould with final packaging. The system is made of a versatile X-Series SM3
side-entry robot, working hand-inhand with an X-Series SPIN 2, the revolutionary Campetella SCARA with high strokes and integrated wrist; • Stack-moulding applications for single-dose strip take-out and stacking, created by using the X-Series MC2 top-entry robot, equipped with electrical axes on wrist; • Suture-tray production in stack mould with ultrasonic welding, vision inspection quality control systems and stacking. A smart combination of sideentry robots, SCARA and handling systems exclusively designed by Campetella; and • Take-out solutions of graduated cups fulfilled by side-entry robots designed to ensure maximum productivity. Through modular and highly industrialized robotic systems, Campetella Robotic Center is able to automate even very complex production processes for all technologies, from high-speed takeout to boxing. Due to its consolidated knowhow, Campetella offers a consulting service that begins with a careful analysis of the customer’s needs that identifies the best solution for the process optimization. Campetella’s mission is to accompany its customers throughout their automation processes, from initial design to after-sales assistance, located in 32 countries worldwide. A widespread assistance network that doubles as an added value for its customers who know they can count on a highly responsive and efficient partner, especially in a period marked by repeated lockdowns.
WWW.MEDICALPLASTICSNEWS.COM
15
BIG STRIDES IN SMALL
BATCH ASEPTIC PROCESSING CINDY L’ESPERANCE, OWNER, SEVEN STONES INC. DISCUSSES THE CONTINUING BENEFITS OF TECHNOLOGY IN THE LIFE SCIENCES SECTOR ON BEHALF OF LEADING GLOBAL PLAYER IN ROBOTICS, STÄUBLI.
G
rowing demand for small batch processing poses new challenges for the life sciences sector. Adapting to variances while maintaining quality, efficiency and adherence to aseptic processing requirements is more complex than ever. Advanced Aseptic Processing (AAP) systems, enabled by robotics and other advanced technologies, offer inventive solutions. The GENiSYS R aseptic small batch filling and closing machine from Automated Systems of Tacoma (AST) is a prime example. AST is a US-based pharmaceutical machine manufacturer specializing in advanced aseptic filling equipment and packaging machines, and a pioneer in the use of robotics in the fill/finish industry. Its relationship with Stäubli goes back more than two decades. In 2010 AST chose Stäubli to develop a multi-format robotic filling machine – the first ever capable of processing different types of container formats on a single machine. The GENiSYS R, launched in 2018, represents another noteworthy innovation. This flexible modular system automates aseptic filling and closing of ready-to-use vials, syringes and cartridges in strict accordance with CGMP requirements. It can be integrated with isolatorbarrier or RABS technologies to maintain required aseptic conditions in tightly controlled ISO 7 and ISO 5 environments. The GENiSYS R is optimized for small batch filling, with a focus on dosing precision and high yield, and uses robotics to achieve 100 per cent in-process control (IPC). This makes it ideal for clinical and commercial applications in drug manufacturing, compounding, cell and gene therapy development, personalized medicine, cytotoxic drug processing and other areas. The IPC provides real-time fill weight feedback and control, which can be used to identify issues early on, ensuring quality, minimizing waste, and maximizing product yield. Electronic batch record (EBR) software records key production data that can be used to create 21 CFR Part 11-compliant batch reports.
Stäubli robots are known for their ability to maintain high speeds without sacrificing performance
16
The combination of modular design and advanced robotics allow the GENiSYS R to be configured to meet different process requirements and containers without the cost or extra time associated with customization. Operators can program recipes specific to container formats and drug products, as well as precise robot movements and pump settings, using the intuitive human-machine interface (HMI), ASTView. This can include finetuning needle fill depth and speed to prevent bubbling, or exact positioning in a given space to mitigate air disturbance, for example – with minimal downtime during changes. The system’s modular design also provides flexibility with regard to the degree of automation desired: Bag and tub opening can be manual, semiautomated, or fully automated, while filling and vial sealing are always fully automated. THE ROLE OF STÄUBLI ROBOTS: STERILITY, QUALITY AND SAFETY ASSURED For pharmaceutical and biotech labs tasked with processing complex small batches, there can be no compromises when it comes to precision, flexibility, reliability, IPC, and protection from contamination. Thus, Stäubli’s sixaxis TX2-40 and TX2-60 Stericlean robots, which excel in meeting these requirements, are integral to the GENiSYS R. They are entrusted with a variety of delicate and repetitive yet critical tasks that could otherwise put product quality, the operator or the end user at risk. In addition to its past experience with Stäubli, AST had a variety of reasons
WWW.MEDICALPLASTICSNEWS.COM
ROBOTICS AND AUTOMATION
If some tasks along the production line need to be manual, the GENiSYS R can easily accommodate that need while ensuring operator safety and product sterility. The robots offer reliable repeatability in their motions as they carefully manipulate the nest and vials, which is essential to reducing particle generation, air disturbance, unexpected vial shaking, and other potentially damaging variables. This helps prevent spills and other incidents that would otherwise result in unplanned manual interventions, which risks compromising the aseptic environment. for choosing Stericlean robots for the GENiSYS R. As CEO Joe Hoff explained, “We needed robots that are reliable over a long period of time, extremely precise, and completely sterile, and the Stericlean line is designed for exactly that.” Stäubli’s Stericlean range is suitable for GMP grade A and grade B tasks, and known for high performance in aseptic and sterile conditions. Extremely low particulate generation and VHP-resistant design enable the robots to reach cleanliness level ISO 2. They feature a fully enclosed IP65 arm with IP67 wrist, as well as an entirely smooth surface free of retention areas and coated with a high-resistance surface treatment. The arm is also equipped with specialized lip seals, and cables run through the arm and out vertically through the base. Critical parts are made of stainless steel.
The use of the Stäubli robots engineered for use in aseptic environments and endowed with exceptional dexterity play a significant role in the GENiSYS R’s high flexibility, enabling the precise filling and closing of readyto-use nested, pre-sterilized vials, syringes and cartridges. Without these advanced robotic capabilities, the changes between recipes and formats demanded in small batch processing would be impossible or prohibitively complex.
A spherical work envelope and compact size make TX2 robots easier to integrate within machines like the GENiSYS R. They can work nimbly in tight workspaces, and their small footprint allows optimization of the surrounding workspace. Speed and repeatability are also important considerations. Stäubli robots are known for their ability to maintain high speeds without sacrificing performance: The GENiSYS R can process up to 20 units per minute, depending on container, product, and IPC rate. Several unique attributes make this possible, even when using NSF H1 food-grade oil. Chief among them is Stäubli’s own patented gearbox, which the company manufactures in-house. This ensures minimum backlash and unmatched arm rigidity, allowing for extreme repeatability – translating to higher speed, shorter cycle time, and greater productivity. FLEXIBILITY FROM OPENING TO CLOSING Depending on the level of automation desired within the GENiSYS R system, the TX2-40 and TX2-60 Stericlean robots can handle or assist with critical steps in each stage of the aseptic process: bag and tub opening, filling, stoppering, sealing/closing, and reject handling.
17
ROBOTICS AND AUTOMATION
High-contact industries: WHY WE STILL NEED TESTING SALIENT BIO CO-FOUNDER JACK PRIESTMAN DISCUSSES RECENT HEALTHCARE CHALLENGES, AND THE NEED FOR CONSISTENT SOLUTIONS.
O
ur testing capacity will continue to play a vital role in the fight against Covid-19, notwithstanding the great breakthroughs made in developing vaccines. News that vaccine rollouts were beginning around the turn of the year prompted a spike of emotional – and economic – relief, if only briefly. There is cause for optimism. However, for high-contact industries, more immediate respite may come from increased availability of same-day Covid testing.
These workers would be better equipped to drive sustained growth in the sector if they were assured of their continuing good health.
These industries would benefit immensely from same-day testing in the workplace, not least because it would provide a platform to recovery after a torrid 2020. Easier access to sameday tests would also help high-contact professions cope with the challenges of doing business in the prolonged pandemic, be they logistical or psychoemotional. Moreover, increased testing provision would improve resilience against other uncertainties beyond Covid-19.
MITIGATING BREXIT-BASED DISRUPTION In terms of uncertainties external to Covid-19, Brexit remains a behemoth. Despite the saga of negotiations reaching its climax over Christmas, business group Logistics UK has warned that post-Brexit arrangements will still come with extra baggage – largely in the form of additional bureaucracy with the potential to derail supply chains.
SUSTAINING RECOVERY Widespread availability of rapid testing would help certain sectors build on the optimism of early 2021. UK logistics, for example, is expected to enter a ‘golden age’, following last year’s recordbreaking rise in square-footage take-up to a total above 42 million. This 69 per cent increase may herald further growth for the sector, with the pandemic catalysing the shift from bricks-andmortar retail to ecommerce. For now, though, the potential for further growth remains exactly that. To deliver on this potential, we should equip UK logistics with the testing capacity to remain resilient against additional waves of Covid-19. Although increasingly automated, the sector still relies on humans to keep businesses running.
SUPPORTING SUPPLY CHAINS Similarly, same-day testing would enable manufacturers to keep pace with recovering demand without exacerbating issues through the supply chain. After months of decline, demand for UK-manufactured products was close to levelling off at the end of 2020, and the industry will need to remain operational to maximise revenues this year. Increased testing capacity is also crucial to this objective. Regular testing would limit the ongoing impact of the pandemic on UK manufacturing, building resilience against disruption into otherwise vulnerable just-in-time supply chains, and freeing up resources to focus on other challenges.
Substantial testing capacity would facilitate the incorporation of diagnostics into emergency logistical procedures such as ‘Operation Stack’, dramatically reducing the risk of hauliers acting as lethal conduits of Covid-19. This would also benefit supply chains because rapid, reliable testing would limit the number of delays attributable to the need for workers to self-isolate. SAFEGUARDING WELLBEING With England’s third national lockdown reportedly triggering an ‘unprecedented crisis’ for the population’s mental health, the psycho-emotional benefits of same-day testing should not be ignored. One survey reported that 66 per cent of workers feared catching Covid, while a further 62 per cent worried about spreading the virus at work. Supplying a safe working environment through regular testing would therefore make workers happier as well as healthier, which can only be good for business. There are thus multiple gains to be made from regular, rapid, and reliable Covid testing in high-contact industries. Sameday testing would provide workers with peace of mind, a welcome boost for their mental health which will hopefully match the renewed optimism around economic performance in 2021. Indeed, this year will bring its own challenges and uncertainties, but a proper testing programme would preserve economic and emotional wellbeing until the pandemic is eventually over.
References 1 https://www.cityam.com/uk-logistics-sector-take-up-soars-to-record-level-as-retailers-scramble-to-boost-delivery-capacity/ 2 https://logistics.org.uk/media/press-releases/2020/december-2020/brexit-deal-protects-economy-but-still-much-to-do 3 https://www.telegraph.co.uk/news/2021/01/12/third-lockdown-has-triggered-unprecedented-crisis-mental-health/
18
WWW.MEDICALPLASTICSNEWS.COM
TESTING AND INSPECTION
GREENLIGHT GURU HAS ANNOUNCED THE LAUNCH OF HALO FOR CHANGE MANAGEMENT, THE WORLD’S FIRST AI AND MACHINE LEARNING RECOMMENDATION ENGINE FOR MEDICAL DEVICE QUALITY.
HELLO HALO H
alo for Change Management is being hailed as a revolutionary and innovative product that provides quality and product teams with recommendations of items impacted by a change order and the real-time visibility needed to discover, assess and manage the impact of a change. Identifying every document affected by a proposed change order and understanding their impact is a tedious, error-prone process. Medical device organizations are left flying blind in their complex quality environment while managing the pressures to balance speed, quality and costs. Without full visibility and strategic insights, many organizations find themselves reacting to change because of siloed information, labor-intensive searches, and increased risk from missing important assets. For example, when executing a change order, the first step is to trace and identify all items affected by the change, which is very manual and leaves room for human error. Documents and quality artifacts are siloed-away in different departments, leading to things being missed during the first pass and subsequently requiring multiple change orders to be conducted. This not only presents extreme inefficiencies to the change management process, but also exposes companies to major compliance risk, or worse, potential patient safety concerns. David DeRam, CEO at Greenlight Guru, said: “Our recent 2021 State of Medical Device Quality Report revealed that, currently, 60 per cent of organizations rely on traceability for conducting change, while 28 per cent of medical device professionals say it still takes a full day or more to run a change impact analysis. This tells us that medical device professionals are working from a reactive state that is tedious and error-prone, limiting organizations from gathering the quality insights that are needed to stay ahead of change. “Halo for Change Management is the first AI feature that allows you to predict the impact of your change and provides you with
recommendations for what is impacted by a change, giving you real-time visibility, reduced risk, and overall improved quality.” By leveraging AI and machine learning capabilities, Halo for Change Management goes beyond the human capacity to predict downstream impacts and gather actionable recommendations to transform your change management process. No longer do organizations have to put compliance at risk by changing or referencing multiple change orders during an audit. Now teams can spend more time designing quality products and less time doing paperwork. Demonstrating traceability and understanding the impact of a change is made seamless through a solution that replaces reactivity with predictability. Kyle Rose, President at Rook Quality Systems, added: “Halo for Change Management automatically gathers all of the quality data and documents that may be impacted by a change and presents it to the user to clearly identify the scope of the change. This is one of the hardest compliance issues to manage manually and will greatly improve efficiency for all Greenlight Guru users.” Halo for Change Management introduces new efficiencies to the change management process that allows medical device organizations to move away from siloed, reactive decision-making and adopt a predictive approach to quality management that enables the best possible outcomes for both the patient and your business.
WWW.MEDICALPLASTICSNEWS.COM
19
TESTING AND INSPECTION
Testing times CHRISTIAN DICKEY, BIOMEDICAL ENGINEER AT KEN BLOCK CONSULTING, DISCUSSES THE ADVANTAGES OF FAST ACTION IN PPE COMPLIANCE.
T
he COVID-19 public health emergency created a worldwide shortage of personal protective equipment (PPE). The FDA responded to this shortage through issuing multiple Enforcement Policy documents and Emergency Use Authorization (EUA) documents for PPE – including respirators, face masks, face shields, gowns, and gloves. These temporary FDA policies allow for the marketing and distribution of certain medical devices without meeting the full “standard” FDA regulatory requirements. Although many of the same products are eligible under both the Enforcement Policies and the EUAs, there are different regulatory requirements applicable when following an applicable Enforcement Policy vs. following the applicable EUA. In addition to different requirements, EUAs are only issued and enforced during a declaration of emergency by the U.S. Department
of Health and Human Services (HHS), whereas Enforcement Policies can be issued at any time and are not dependent on a declaration of emergency. The key differences, discussed below, may impact a manufacturer’s distribution timeline and marketability of their product(s). RIGHT POLICIES – RIGHT TIME Face masks, surgical masks, face shields, respirators, gowns, other surgical apparel (including surgical suits, caps, shoe covers, etc.), and gloves are included in the FDA’s current COVID-19 Enforcement Policies. These medical device specific policies include the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” published by the FDA in May 2020 and the “Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency” published by the FDA in March 2020. These policies have established requirements for manufacturers, importers, and distributors to allow for the distribution of PPE without compliance to the following regulatory requirements: Premarket Notification, Registration and Listing, Quality System Regulation, Reports of Corrections and Removals, and Unique Device Identification. The FDA has also released product-specific EUAs for many of these same categories of PPE. Similar to the Enforcement Policies, these product-specific EUAs identify the reduced requirements for distribution of each product category, during the COVID-19 public health emergency. The EUA and Enforcement Policy requirements differ based on the type of PPE, which is dependent on design, intended use, and labeling claims. For
20
WWW.MEDICALPLASTICSNEWS.COM
TESTING AND INSPECTION
The FDA requires that manufacturers have an established MDR process and have conducted testing on the fluid resistance and flammability of the surgical mask instance, the most heavily regulated PPE category under the EUAs are surgical masks. Some of these additional requirements include testing for fluid resistance, flammability, particulate filtration efficiency, air flow resistance, and biocompatibility. In addition to meeting the EUA standards established for this category, this type of PPE requires a formal EUA submission to be filed with the FDA. Therefore, labeling a mask as intended for surgical use can further complicate and delay distribution of these masks in the situation when the same product could instead be marketed and distributed as non-surgical medical masks. On the other hand, PPE that falls into the FDA-defined category of face masks has the minimum requirements of all the EUA-regulated face mask/respirator products. Face masks, as defined by the FDA, are those products that cover both a user’s nose and mouth and are intended for use by the general public and healthcare providers in accordance with the CDC recommendations. These masks still can, but do not need to, meet fluid barrier or filtration efficiency levels. The product requirements for face masks include establishing a Medical Device Reporting (MDR) process (refer to 21 CFR Part 803) and inventory control process, conforming to labeling requirements as stated in the EUA, and maintaining all records associated with product distribution under the EUA. Once these requirements have been met, the manufacturer can begin distribution in the US market, without an FDA submission. APPROPRIATE TESTING The above are just two examples of different PPE categories included in the most recently published EUAs. They highlight how labeling and intended use can cause disparities between the regulatory timeline of different product categories identified under the EUAs. As mentioned previously, manufacturers can also choose to market applicable products under the current Enforcement Policies. Using the previous example of surgical masks, the FDA requires that manufacturers with a product in this category have an established MDR process and have conducted testing on the fluid resistance and flammability of the surgical mask. Unlike the EUA for surgical masks, the FDA does not require a submission prior to distribution. This example depicts how the current Enforcement Policy requirements are less strict than those under the current EUA for surgical masks. Despite Enforcement Policies typically requiring less performance testing of products, there are very specific labeling requirements that must be adhered to. Even so, products can often be distributed more quickly under an Enforcement Policy due to the more limited FDA regulatory requirements.
route of selling the product in the U.S. market during COVID-19. Deciphering these new regulatory policies can be challenging, and deciding which policy will help your company reach its desired outcome can be even more difficult. In my role as a Biomedical Engineer at Ken Block Consulting, I have had the opportunity to work with various medical device companies to develop regulatory strategies that fit their bottom line. Most recently, I worked with a company that was attempting to enter the U.S. market using an EUA, but they struggled under the guidance of another regulatory specialist. Seeking regulatory guidance is important, but not all consultants are equal. Without the proper experience and knowledge of these new policies, a manufacturer risks wasting significant time and money. In addition to seeking the proper guidance, manufacturers are encouraged to review the FDA website for further information on specific EUA and Enforcement Policy requirements. Finally, companies should plan for the long-term marketability of their products beyond the current pandemic. Specifically, many of the PPE products currently allowed through an applicable Enforcement Policy and/or EUA will require 510(k) clearance by the FDA once the pandemic is over (which will also require the company’s Quality System to be in compliance with all sections of 21 CFR 820). Working now to establish both the full FDA-compliant Quality System and create the necessary 510(k) submissions will allow continued distribution of PPE products beyond the pandemic period.
Although the Enforcement Policy may allow you to market your product faster, marketing a product under an EUA can be beneficial for the device’s marketability. EUAs require more performance testing and procedural documentation, but surgical masks and respirators that are authorized via an EUA are published for customers to see on the FDA website, which may provide more market visibility for the product. Depending on each manufacturer’s current Quality System and existing performance testing of their product(s), the Enforcement Policy or the EUA may be the more strategic
WWW.MEDICALPLASTICSNEWS.COM
21
The shawpak is a revolutionary machine offering a thermoforming solution to your medical packaging needs that is totally unique
IDEAL FOR INTEGRATION INTO ROBOTIC CELLS AN OPTIMUM SINGLE-PIECE FLOW SYSTEM BLISTER PACKAGING FOR MEDICAL DEVICES SEE US VIRTUALLY
COMPAMED
SEE US AT MED-TECH INNOVATION Hall 1, Stand F9 29-30 June 2021
shawpak Riverside Medical Packaging, Newmarket Drive, Derby. DE24 8SW. T +44 (0) 1332 755622 | F +44 (0) 1332 757722 W www.shawpak.co.uk | E sales@shawpak.co.uk
CLEANROOMS
Quick and clean CONNECT 2 CLEANROOMS EXPEDITED THE DESIGN AND BUILD OF A TEMPORARY MEDICINES UNIT FOR NHS WALES’ NEW CENTRAL INTRAVENOUS ADDITIVE SERVICE (CIVAS).
D
uring the first COVID-19 surge, the UK Government increased CCU bed numbers by 3-4 times. However, it wasn’t possible to increase the number of critical care nurses overnight. With an urgent requirement for specialists to cover more beds, ways in which CCUs could apply lean principles to generate efficiencies were explored. One of the main activities that takes critical care nurses away from patients is making up their intravenous drugs. The Welsh Government therefore created a central manufacturing capacity to make the sterile injections for critical care to support CCUs. The new CIVAS temporary medicines unit can now produce up to 2,600 syringes per week. The MHRA determined that this process would need to be conducted in cleanroom facilities, so NHS Wales partnered with Connect 2 Cleanrooms (C2C) to fast-track a purpose-built facility, including GMP qualification from DQ to PQ. It was ready for inspection in just six months. Paul Spark, Pharmacist at NHS Wales, said: “The company pulled out all the stops to begin with at design stage and the same urgency went right the way through the construction phase.” CONSTRUCTION DURING COVID-19 Increasing the speed and safety of construction was a challenge for C2C’s site lead, Craig Druce, who said: “We brought in specialist subcontractors to install the more complex elements of the builtenvironment, such as the interlocking door and alarm system, at speed.” With multiple teams working on the same build, greater consideration was given to planning the programme schedule and on-site organisation to ensure teams were kept separate. Working on a split level helped teams stay distant. C2C used signage and hygiene stations to create a designated buildzone within the NHS facility, restricting access to essential personnel only. Druce added: “The forward planning and more detailed programme schedule supported a faster and more efficient COVID-secure build. We’ll continue to spend more time forward planning throughout 2021 and beyond ... On projects such as this, a shortened installation schedule is of great benefit to our clients.”
GMP QUALIFICATION The GMP manufacturing environment is designed to diminish the risks inherent to sterile manufacturing, such as viable and nonviable particulates, as well as crosscontamination. Joan Benson, C2C’s Regulatory Governance and Assurance Manager, said: “It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the lifecycle of the product and process. Our qualification process is therefore not an independent activity, but an integrated application of GMP practices.” Design Qualification (DQ) documented and verified that the proposed design of the facilities, systems and equipment was fit for purpose. Factory Acceptance Tests and Site Acceptance Tests evaluated any bespoke or customised equipment and determined the functionality before and after installation. Installation Qualification (IQ) then documented that the facility and equipment provided what was required. Operational Qualification (OQ) demonstrated that the cleanroom would consistently perform and maintain the specified conditions, by using a series of challenges such as smoke visualisation testing. For the initial Performance Qualification (PQ), test engineers repeated what had been done at OQ but under load, rather than as built. Complete system operation training ensured a simple client handover and NHS Wales now has a full O and M manual to ensure smooth operations.
WWW.MEDICALPLASTICSNEWS.COM
23
MAKING DRUG DELIVERY DEVICES
A design for life ANDALTEC’S EXPERTISE HELPED A MADRID-BASED NURSE DEVELOP AN EASY-TO-USE SYRINGE CONTAINER AND FOUND HER OWN BUSINESS.
A
ndaltec, the Technological Centre for Plastics, has participated in the development of an innovative syringe carrier device to be used by health workers in emergency and catastrophe situations. This tool, which has been devised by nurse Ana Cintora, is primarily a container that allows for syringes already loaded with medication for immediate or gradual administration to be correctly aligned and ordered. The syringe carrier is a device unique in the market due to its numerous advantages: it is easy to clean, sterilisable in a microwave and allows for medication to be accessible, without being carried, leaving the health worker’s hands free to perform other tasks. Moreover, it is ergonomic and helps to increase efficiency when injecting medicines. The nurse behind this project came to Andaltec with her initial idea; since then, Andaltec has been involved in the whole development process, participating in the design, material choice and prototype manufacture, as well as carrying out the experimental tests on the syringe carrier’s prototype. ALL ABOUT CHOICES Andaltec’s technicians proposed some design improvements, such as placing the device on a belt upon which the container could be attached with a clip, making it capable of rotation, and enabling the possibility of placing it in parallel or perpendicularly to the worker’s body, so that it can also become a useful working table. The device’s inventor has also been advised on the most suitable material choice, polypropylene in this case, as well as on the cost of moulding and serial part manufacturing. Thus, it will be possible to market a low-cost and high-quality device. Cintora said that she decided to launch this project when she realised there was nothing like it in the market: “Up to now, it was necessary to carry the medication, which needs to be loaded and accessible, in a tray or in our pockets, but carrying syringes in a pocket isn’t safe and the tray implies having at least one hand busy. Besides, the syringe carrier can be cleaned and sterilised after each patient, which makes it a very safe system.”
The syringe carrier can be cleaned and sterilised after each patient, which makes it a very safe system Cintora highlighted how the help provided by Andaltec brought her idea to life, as the Technological Centre’s intervention has enabled a much more complete device. “Andaltec has guided me through the whole process and they have suggested very valuable improvement measures that have been very helpful to develop the product,” she added. GETTING IT TO MARKET Once the device is completely developed and its successful industrial scale production has been ensured, Cintora will be establishing a start-up company, for which she is currently looking for investors to help market the product. Her goal is making the product available in Spain during the first semester of 2021. Mari Ángeles Pancorbo, Technician in Andaltec’s Projects Area, added that this project is proof of the way Andaltec can help entrepreneurs turn their ideas into a viable product: “This is a very clear example that R&D investment is indeed very profitable, as we offer comprehensive support that allows entrepreneurs to realise a product ready to be marketed.” Andaltec has also brought its extensive experience to other products for medical applications, such as a device to avoid tearing during childbirth, developed alongside a researcher from the University of Jaén. The Technological Centre for Plastics has also created 3D models to prepare doctors for surgeries, and is currently executing the PoliM3D Project, intended to obtain active polymers designed for 3D printing in medical applications.
24
WWW.MEDICALPLASTICSNEWS.COM
CUTTING AND SEALING
A CUT ABOVE MARTIN FROST, UK SALES MANAGER, TELSONIC UK LTD., DISCUSSES THE PRINCIPLES AND BENEFITS OF THE CUT’N’SEAL PROCESS, WHICH HAS SEEN A GROWING NUMBER OF MANUFACTURERS INCORPORATING THE TECHNOLOGY.
T
he Cut’n’Seal process uses ultrasonic energy to cut or punch out a range of thermoplastic and synthetic materials whilst time sealing the edges. The process can also join the individual components to a secondary item. Capable of cutting and joining a range of substrates, the Cut’n’Seal ultrasonic process is a mature, well-established technology used in a number of applications in filtration, garment, medical, wound care and healthcare products. There are many items manufactured from multiple layers wherein it is essential that the finished item has no frayed edges, loose threads or does not delaminate in use. In certain cases, and in addition to the aesthetics and integrity of the product, there are also instances wherein the ultrasmooth edge produced is an essential attribute for items which will come into close or constant contact with the skin. The Cut’n’Seal process is capable of meeting all these requirements, which is why the technology is being adopted by manufacturers across multiple inductry sectors. Examples of where the Cut’n’Seal process has proven to be indispensable include the highvolume manufacture of labels, wound care products, feminine hygiene products and filter pads used in respiratory support machines for patients suffering from sleep apnoea. In addition, the flexibility of the process means it can be incorporated into a wide range of manufacturing technologies.
TYPICAL REEL/REEL FED IN-LINE SET-UP For high-volume products, the typical configuration would be a reel-fed indexing system wherein pre-laminated multi-layer material is passed between the sonotrode(s) and anvil(s). The individual pads, which have been both cut and sealed, are then pushed through the anvil by pneumatically operated plunger mechanisms and collected in tote boxes, ready for packaging. The skeletal waste of the original material is then fed onto a separate reel on the output side of the machine. This configuration, depending upon product design and reel width, allows for either single or multiple products to be produced in each cycle. Changeover between product types or shapes is achieved by simply changing over the sonotrodes and anvils, and if required, adjusting the position and/or pitch of the tooling. Telsonic’s Cut’n’Seal technology is capable of achieving cut cycles of between 140/170ms representing a very small part of a machine’s overall process and index time. PICKED BY ROBOT The Cut’n’Seal process is also easily integrated into systems where robots are being used. For example, the robot removes the cut and sealed pads from the anvils and loads them into intermediate trays prior to presentation into filter housings further upstream. Another Cut’n’Seal configuration often employed is that of twin headed systems, but offset sonotrodes and anvils. This utilises wider web substrates where two smaller pads can be produced in a tandem cycle whilst optimising material usage. In a configuration such as this, the reel-fed material is typically between 100-150mm wide and between 100-150gsm in thickness. The typical throughput for a system such as this would be a total of 60 pads per minute, dependant upon material type and thickness. The rapid rise in the demand for surgical type face masks, initiated by the COVID-19 pandemic, brought with it a significant increase in the the number of UK companies diverting their resources to manufacturing these products using automated systems. Telsonics’ ultrasonic technology with the Cut’n’Seal process is used to produce cut and formed mask types such as K95/N95 and FFP2/ FFP3 variants. DUAL, OFFSET SONOTRODES AND ANVILS The quality, consistency and short cycle times of the Cut’n’Seal process, combined with the ability to easily configure and integrate the technology to suit individual applications, are just some of the key drivers behind the increasing uptake. In addition, developments in wound care technology with new materials, new feminine hygiene products, plus the demand for increased production of PPE have together opened up a wide range of new applications for this process, which also adds value by delivering a superior finished product.
WWW.MEDICALPLASTICSNEWS.COM
25
MediPlas Pavilion at InterPlas 1
Highly specialised area focussing on manufacturing for the medical plastics industry.
2
Organised in conjunction with and sponsored by Medical Plastics News Magazine.
3
All areas of the medical plastics supply chain covered by leading industry experts.
4
Returning to the NEC Birmingham, 28-30 September 2021.
02:2021 Sukano PLA masterbatches confirmed effective against SARS-Cov-2
S
ukano high-performance Antiviral Masterbatch is designed to protect surfaces from acting as a transmitter. To further support safety and hygiene, Sukano has introduced an Antiviral Masterbatch for PLA applications to the market. This masterbatch helps to eliminate viruses and other microorganisms from surfaces.
The company has now tested the effectiveness of the Masterbatch against SARS-Cov-2 and Influenza H1N1 on PLA, among other polymers, in a specialized in microbiological certified external laboratory. With success – a 99% reduction of SARSCov-2 within 30 minutes on the PLA fabric samples and 99.9% reduction within 2 hours. For the Influenza H1N1, a reduction of 99.99% on a coex film was confirmed after 30 minutes.
RICO REPORTS POSITIVE RESULTS IN YEAR SHAPED BY CORONAVIRUS
A
ustrian mould manufacturer and silicone parts producer RICO recorded an increase in revenue and also hired new employees in 2020. Managing Director Markus Nuspl said: “In March [2020] we were caught between two stools. On the one hand, our mould production order books were full. But on the production side, call-offs from certain sectors all but
collapsed from one day to the next.” Later in the year the company saw an upswing as production returned to full capacity. “That was due in no small part to our balanced mix of customers from different industries,” Nuspl added. The rebound in orders in the second half resulted in the company taking on more than 20 additional employees.
TOYOCHEM INTRODUCES HIGH MOISTURE-PERMEABLE ACRYLIC ADHESIVES FOR HEALTHCARE
T
oyochem Co., Ltd., the polymers and coatings arm of Japan’s Toyo Ink Group, has launched a new healthcareuse line of pressure-sensitive adhesives (PSAs) under its Oribain brand of acrylic adhesive solutions. The new PSA system
26
addresses the demand for medical tapes and surgical dressing materials that offer high moisture absorbency and breathability, thus minimising skin maceration and infection. The adhesive compositions are based on acrylics – not silicones – so they do
W W W. M E D I C A L P L A S T I C S N E W S . C O M
contain any substances that may contaminate coating environments or cause costly bonding issues. Toyochem is now looking to strengthen its presence in the global medical adhesives market, particular in dressing and surgical tape applications.
