MPN EU Issue 67

Regulars

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Editor’s Comment

GREEN AND BEAR IT

As another year draws to a close, it’s only natural to be thinking about new year’s resolutions. Everyone makes a resolution in hopes of quitting something, picking up a new hobby or maybe travel more. Why choose a resolution that only affects yourself when you can make such a bigger impact?

Why not choose to go greener? Knowing you’re making a difference to the planet by doing something so simple as recycling or riding a bike to work can be so rewarding.

Sustainability is at the forefront of the medical sector. Between plastic waste, packaging waste and CO2 emissions, the medical industry has a huge impact in the environment. A Health Care Without Harm and ARUP report found that the healthcare’s climate footprint equals 4.4% of global net greenhouse gas emissions. So, many companies now are working hard to be more responsible in reducing their carbon footprint.

Every company has their own unique sustainability goals and while there isn’t one standard solution to improving the environment, there is one goal that everyone is aiming for - becoming carbon net zero. In the UK, the National Health Service is aiming to become the world’s first carbon net zero national health system by 2040. With the influence and power the NHS has, this could have a significant impact in the shift towards everywhere becoming carbon neutral.

Reducing plastic waste is a big challenge in this industry. The best advice is plan, plan, plan. Having a waste management system in place can reduce waste by a lot. Minimising the amount of waste not only reduces harm to the planet, but also reduces

Raumedic has reduced their waste per kilogram produced by 35% in the last three years alone and reduced their CO2 emissions by more than 1300 tonnes in the last seven years.

Some materials, such as polyvinyl chloride (PVC) are not considered eco-friendly, as it is made by a chemical reaction between chlorine, carbon, and ethylene and causes the release of harmful chemicals, which harms the environment. Replacing PVC is no easy feat, as it is low in cost and safe, thus the material of choice for many medical devices. While some companies are working on replacing PVC, it may be easier to recycle the material. In Australia, they have the PVC Recovery in Hospitals initiative, which is a programme aimed at collecting used PVC medical products and recycling them into new products.

A material that is commonly replaced in the medical sector is thermoset rubber. Thermoplastic Elastomers (TPES) are a popular choice across many industries. Both materials behave similarly, however TPEs are able to be recycled more easily. Teknor Apex, is one company that uses TPEs, and have had a lot of recognition for their sustainable work. The company recently received their +Vantage Vinyl certification, by the US Vinyl Sustainability Council for meeting all the necessary requirements. Another medical company that works with TPES, Kuraray, plans on reducing its CO2 emissions by 30% by 2030 and becoming carbon neutral by 2050.

It’s hard to look so far ahead in the future and believe that one industry can make such a difference, but when everyone works together, it will make an impact.

OLIVIA FRIETT

spy

ACCREDITATION UPDATE FREUDENBURG ANNOUNCES TUBING FOR BIOPROCESSING

Freudenberg Medical, a manufacturer of medical and pharmaceutical devices, components and tubing, has introduced HelixFlex, a thermoplastic elastomer tubing designed for use in pharmaceutical and biopharmaceutical applications.

“With HelixFlex, we complement our siliconebased HelixMark and PharmaFocus Premium tubing lines and therefore continue our journey of providing additional products and technologies to our pharmaceutical and biopharmaceutical customers as a one-stopshop. HelixFlex is the next critical milestone in that endeavor.” states Rüdiger

Gall, general manager & director corporate marketing at Freudenberg Medical.

The recently introduced HelixFlex high purity thermoplastic elastomer tubing adds to Freudenberg’s existing pharma product portfolio of silicone tubing and fluid transfer products for bioprocessing, drug and vaccine manufacturing, filling and sampling, peristaltic pumping, laboratory, and medical device applications.

EXTRUSION UPDATE

PTA Plastics receive MedAccred accreditation

PTA Plastics, a plastic injection moulding company, first learned about MedAccred accreditation when plastics assembly was being phased into the programme and the company grasped the opportunity to take part in the pilot, helping to create the audit criteria.

to progress quickly through the stages.”

Significant process improvements were made because of the audits. PTA Plastics reduced finishing defects by 86% and reduced internal scrap from 2.78% to 1.81% of parts produced.

EXPANSION

HELMEE IMAGING ANNOUNCES OPENING OF ITS US BASE

Helmee Imaging, a developer, manufacturer and marketer of unique CSD imaging technology for challenging surface inspection applications, has launched Helmee Imaging, Inc., a wholly owned U.S. subsidiary based in Cumming, Georgia. The new company will provide sales with technical and application support for its

customers throughout North America.

“The customers we work with have increasingly demanding needs for surface quality inspection where traditional methods, such as cameras or human visual inspection, do not work reliably or quickly enough,” said Juha Saily, regional development manager

“As soon as we heard about the MedAccred programme of accreditation we knew it could help us build on our existing relationships in medical devices and open doors with new customers,” says Greg Fish, PTA corporate director of quality. “It is very detailed and quite daunting, but as we did the preaudit self-assessments and began to understand the criteria, we sorted out a manageable plan for Helmee Imaging Inc. “Our CSD technology offers higher resolution, more accurate inspection results and higher throughput than human visual inspection. It is the only inprocess inspection technology that works on parts with complex geometries and mirror-like surfaces.”

CSD (Covered Stereo Deflectometry) is a patented machine vision technology that enables

automated quality inspection of flat, curved and complex parts with highly reflective and clear surfaces. CSD can detect virtually any type of microscopic and larger 2D and 3D defects.

APPOINTMENT

AIM3D presents the Voxelfill process

With the Voxelfill process, AIM3D is overcoming inhomogeneous strength issues by achieving defined, selective densities in the component.

By using the 3D extrusion technology of the CEM process, AIM3D has developed a Voxelfill strategy that overcomes these limitations and increases the cost effectiveness of the CEM process. Voxelfill can also be used for multi-material components and is suitable for constructing 3D components using plastics, metals and ceramics.

With the Voxelfill approach, components are no longer created exclusively in layers, but utilise crosslayer filling by using so-called voxels as volume areas.

The Voxelfill strategy comprises two process stages: 1. Generation of a lattice structure: the CEM system repeats this structure up to a defined

THERMOPLASTIC UPDATE

height of the volume elements, then at this point the previously created cavities are filled by injecting thermoplastic material with the extruder 2. Filling phase of the voxels: now the more important component of this 3D printing strategy is deployed: when the volume areas are filled, this does not include filling all voxels in one plane.

RQM+ appoints new Head of Mergers and Acquisitions

With more than 20 years of experience in the MedTech industry, Mahofski has held various positions at RQM+, including overseeing M&A integration and business development. He previously served as VP of engineering for Circadiance and as a project manager for MEDRAD. In his new role at RQM+, Mahofski is responsible for identifying and pursuing acquisition opportunities that complement its core regulatory services and provide a comprehensive range of fully integrated outsourced solutions to help get MedTech products to market faster and ensure ongoing regulatory compliance.

“We’re rapidly becoming the organisation that will help medical device companies connect the dots from concept through market deployment and maintenance, expediting patient access to life-improving technologies,” said Mahofski. “In the coming years, we will continue to expand our offerings to support MedTech customers throughout the product lifecycle.”

extrusion

By adding Lubmer L5000 from Mitsui Chemicals to its portfolio, the distributor DREYPLAS now has an ultra-high molecular weight grade of polyethylene (UHMW-PE) in pellet form which can be processed like conventional thermoplastics, also suiting it to the extrusion of pipes, hoses and profiles.

One of the first adopters is Novoplast Schlauchtechnik in Halberstadt, Germany. Working hand in hand with DREYPLAS, Novoplast has developed a now patented process for manufacturing hoses from Lubmer L5000 as a continuous reel product.

Known by the product name PE Ultra, these hoses are used in industrial, medical and other applications. Lubmer LS4140, a blend based on chemically coupled PA6 and UHMWPE components, is suitable for similar

applications requiring elevated temperature resistance.

Thanks to being recyclable as polyolefins and the possibility of remelting production scrap and returning it to the production cycle, Lubmer extrusion and injection moulding grades provide environmentally responsible, sustainable solutions.

Can tapes nlock INNOVATION?

Tapes are often viewed as a simple material, secondary to device function. They don’t power a medical device and don’t compute, store, or display any data. While all true on the surface, these assumptions are rooted in a crucial misconception.

When a closer look is taken, it becomes clear that tapes are a critical part of enabling a device to function as it’s intended. Tapes can adhere device components together and stick the device to the skin, doing both for the device’s intended wear time. When either of these functions fails, the device could fall apart or detach from skin, affecting its ability to help the person using it to transform their health.

Not just any tape will do, especially when sticking to skin. Tapes with elastomeric backings – ones that can stretch, recover, and then stretch again – make many modern devices capable of functioning the way they do and the potential for future innovation possible.

TAPES HELP MAINTAIN SKIN HEALTH

Tapes must accommodate unique challenges to be successful, regardless of their function in the overall device design. If they’re holding components together, they must do so without interacting with other materials or the device’s ability to track data.

If they’re sticking a device to skin, they need to have an elastic and breathable backing, which allows the skin to breathe and expel moisture while stretching and flexing just as skin normally would, all the while holding something that very much does not stretch – like a rigid backing or device –on top of it. This is where elastomeric tapes can really shine.

Skin may reject whatever is stuck to it by forcing the tape off or react to it by developing a rash or other irritation. The device’s ability to reliably fulfil its duty then diminishes.

Creating next-gen devices requires that tapes be designed into the system early. Selecting the best one should start with reframing the tape’s performance criteria from what properties the tape needs to possess to a more holistic approach: what the device needs to achieve. Your materials partner can better identify options that serve the device’s entirety, rather than options that meet a narrower set of expectations.

TAPES HELP SAVE ON HEALTHCARE COSTS

When a tape cannot perform the way it needs, there’s a domino effect that goes beyond a singular layer.

It could mean data is no longer reliable or being collected. The person

using the device then cannot track their health status and adjust their behaviour when needed. Their care provider can no longer use that information to consult and treat. Health could worsen and additional care may need to be sought.

When tapes are performing optimally, they can allow longer device wear times and maintain skin health. Health statuses can be tracked, and therapy extended from the comfort of homes. And the body’s largest organ can function, without being jeopardised by something meant to help it.

TAPES HELP USHER IN IMPROVED DESIGNS

It’s not enough to create a device that reliably and accurately tracks the data it needs to track. It also needs to accommodate the end user’s preferences and fit into their daily lives as seamlessly as possible.

Tapes have the potential to help solve some of the toughest design challenges. They can offer more flexibility in slimming down profiles and weight because they take up less space than mechanical fasteners.

Elastomeric tapes can make devices more comfortable to wear and stay adhered longer because of their ability to stretch and move with the skin.

In a world with rapidly transforming devices, designs need to be innovative and utilise all the advantages they can to make it to market successfully.

MATTHEW BONGERS, PRODUCT DEVELOPMENT ENGINEER, AND AUDREY SHERMAN, DIVISION SCIENTIST, FOR 3M MEDICAL SOLUTIONS DIVISION HIGHLIGHTS THE IMPORTANCE OF ELASTOMERIC ADHESIVES

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All OutSTR TCHED

With so many different thermoplastic options, it’s difficult to know what’s best for different medical devices.

Elastomers specialist, Kuraray, has been in the business for 96 years. The company has been producing styrene block copolymers since the 70s, as well as having over 20 years’ experience with HYBRAR material in medical application for flexible PVC replacement.

HYBRAR POLYMER

HYBRAR is a special type of block polymer. It has vinyl content in the chemical structure, so the materials allow a much better compatibility compared to polypropylene.

Bianca Carvalho, assistant manager of sales, Kuraray, explained: “This is a very soft block polymer. You can produce a TPS compound based on the mixing of the polypropylene or some polyolefins with the HYBRAR

without the need to use a plasticiser. This is one of the biggest advantages of HYBRAR.”

THE SEPTON 4000 SERIES

The Septon 4,000 series is also a little different from the conventional block of polymers. The conventional one is known as SEBS structure where there is the hard block based on isoprene and middle block based on butadiene.

“With Septon 4,000 series, we have a mix of butadiene and isoprene on the soft block. This allows to have a polymer that has better elasticity. It also allows the material to absorb and hold more oil, so you can increase the oil amount in the TPS application.” Carvalho said.

“We also have Septon 4033, this has one of the best transparencies in the market. TPS compounds are usually translucent, but Septon 4033 is transparent.”

The Septon 4000 series has the biocompatibility test for cytotoxicity and skin sensitisation, pyrogen and blood compatibility, so that it can be used in the medical sector.

Carvalho noted that some of the benefits of Septon 4000 in comparison to other SEBS include higher oil absorption and retention, higher tensile strength, and good elongation.

THERE ARE MANY TPE OPTIONS TO CHOOSE FROM

There are several categories of different types of Thermoplastic Elastomer (TPE) - inside the TPE you have TPS, TPU, TPA, TPV etc.

“We have a good compatibility with general materials like PP. You can have a solvent bonding, but you can also hand bond with other polypropylene based particles like connectors without any issues.” Carvalho explained.

“With TPV, you mix a polypropylene base with EPDM, and have a crosslink material together with the polypropylene, whereas with the TPS, you basically only have thermoplastic materials. You don’t have a rubber, such as EPDM. So, with the TPV, there’s always this crosslink in one of the polymers.”

REGULATION

Carvalho stated that Kuraray’s biggest challenge is related with the European Medical Device Regulation. The regulation becomes more and more restricted over the years, and this affects a lot of the supply chain itself, and the raw material.

Carvalho said: “With the challenges that we’ve had in the past two years for the supply chain, we can’t easily make adjustments, like raw material. For the medical sector, this created some disruptions. We were luckily able to avoid negative impact, and we had no impact at all in the supply chain for medical customers. I think this is something very important.”

OLIVIA FRIETT SPOKE TO BIANCA CARVALHO, ASSISTANT MANAGER OF SALES, KURARAY, TO DISCUSS MEDICAL TPE GRADES

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GMP ANNEX 1:

The first version of the guidance dates back to 1971 and though there were multiple revisions up until 2010, this was the year when everyone took stock on what the guidance should look like. The document has expanded over the years, from 16 to over 50 pages and was finalised in August 2022 by the European Commission. So, how does it affect medical device manufacturers?

Though it is a European guide for manufacturing, EU GMP Annex 1’s impact is global. As soon as sterile medicinal product is imported into Europe having been manufactured elsewhere, the same practices must be adopted in these manufacturing facilities too.

What drives the spirit of EU GMP Annex 1 is Quality Risk Management and Contamination Control Strategy. Though it is mostly directed at the manufacturer of sterile medicinal products, it’s also important to remember there’s a lot of useful aspects for non-sterile manufacturing including prompts and recommendations.

The Annex 1 contains several major revisions with many references to the implementation of Quality Risk Management as a more proactive approach rather than reactive. The document also highlights the importance of a contamination control strategy and covers 16 different elements, including cleanroom design, qualification environmental monitoring and several other areas. Section 4, concerning the facility, stipulates that the manufacture of sterile products be carried out in appropriate cleanrooms. The environmental monitoring of viable particles and cleanroom qualification is therefore essential. The focus in the EU GMP Annex 1 tends to be on

Grade A cleanroom environments – the most stringent standards that sterile medicine products are manufactured, where in many cases the products cannot be sterilised.

The Annex 1 states that a manufacturer should use a combination of different methods, contact plates, settle plates and volumetric air sampling and not rely on merely one or the other method.

It also recommends that all Grade A monitoring must be continuous and capture the entire duration of operation – a full manufacturing shift. The air handling units in cleanrooms turn over significantly large volumes of air and therefore sampling merely 1 cubic metre is not truly representative and one of the reasons why the Annex 1 calls for continuous viable air monitoring, not sequential monitoring, or sampling miniscule volumes over an extended period of time.

Continuous viable air monitoring in the Grade A zone can strictly speaking be achieved only through volumetric air sampling. Whether passive sampling using settle plates delivers adequate monitoring is open to

AFTER THE LATEST REVISION TO EU GMP ANNEX 1 IN 2022, ERIC CLEMENT ARAKEL, GLOBAL PRODUCT MANAGER AND MYRIAM GUEYE, SEGMENT MARKETING MANAGER –APPLIED INDUSTRIES AT SARTORIUS, EXPLAIN THE EFFECT THE NEWEST FORM OF THE GUIDANCE HAS ON BOTH MEDICAL DEVICE AND PHARMACEUTICAL MANUFACTURERS

SARTORIUS EXPLAINS HOW THE LATEST REVISION CAN IMPACT MANUFACTURERS

debate, but the door has been left open in the document. But bear in mind, it is the use of a combination of different methods that has been recommended.

The EU GMP Annex 1 specifically mentions that monitoring should be for the full duration of critical processing and also recommends monitoring cleanrooms even when operation has stopped.

The document clearly specifies that all interventions caused by the environmental monitoring operation be avoided at all costs. One of the most common interventions being the routine retrieval of impaction plates from volumetric air samplers to avoid dehydration. This is where the MD8 Airscan from Sartorius comes into its own. Paired with gelatine membrane filtration, cleanrooms can be monitored for a tested period of eight hours, typically the length of an entire manufacturing shift. By circumventing routine intervention, the technology is fully compliant with the requirements of the Annex 1 and stays true to its intended spirit.

It is also worth mentioning that both Grade A and Grade B cleanrooms must be requalified every six months with an aseptic process simulation repeated twice a year taking into consideration all human interventions that typically

occur during production. Care has to be therefore taken in minimising all possible interventions, to avoid the introduction of contamination during sterile manufacturing. Routine interventions also typically lead to increased microbiological samples from personnel monitoring.

One of the other key requirements of the Annex 1 in terms of environmental monitoring being that the sampling method not introduce the risk of secondary contamination. By being Vapour Phase H202 (VHP) compatible, the MD8 Airscan facilitates complete decontamination when built in line with the air flow path in advanced aseptic processing systems. Sterile and individually packed gelatine membrane filters, with the retentive capacity of a HEPA filter, are capable of retaining the smallest of viruses. The filters are hygroscopic in nature and prevents the desiccation of retained microbes by forming a protective capsid, enabling long-term continuous monitoring.

Though much of the guidance applies to pharmaceutical products, there is the effect on medical devices too.

Sterile integral drug delivery devices such as single-use pre-filled syringes, inhalers, transdermal patches can be considered as medicinal products that includes a medical device. As the principle intended action is achieved by the drug contained within the device, it is designated as a medicinal product and therefore falls under the guidance. Also implants containing medicinal products whose primary purpose is to release the medicinal product fall under EU pharmaceutical legislation.

The European Medicines Agency (EMA) adopted in July 2021 a guideline for medicinal products when used with a medical device. This guideline considers the three different configurations of medicinal products (integral, co-packaged or referenced) and the addition of the impact of the device on the Critical Quality Attributes (CQA) and overall control strategy in the medicinal product dossier.

The original company, Guardtech Cleanrooms, covered everything – turnkey, modular, portable and quickassembly cleanrooms, as well as all the associated products and services. But at the turn of the year, it acquired Cleanroom Solutions, and that business became the ‘heritage brand’ solely responsible for major turnkey builds.

Guardtech Cleanrooms switched focus to concentrate only on smaller modular builds and relaunched CleanCube and Isopod as standalone businesses, meaning clients can get the exact service or product they need based on their requirements.

PHARMA, BIO AND EQUIP

The company has provided more than 40 CleanCube container and van labs for COVID-19 PCR testing since the pandemic started. The company’s most recent growth has been centred around the new pharma model the company has been working on. It’s ideal for applications like pharmaceutical compounding and Guardtech has recently built several for businesses conducting pioneering Cell & Gene Therapy and Microbiome Therapeutics.

CleanCube Pharma and Bio utilise the base specification of the Midi 40ft container, while the Equip is housed in the Maxi (double container), with the Pharma configured to produce the best utilisation of production space whilst also accommodating the demands of a primary and secondary personnel airlock.

Allowing for a one or two-process room configuration and supporting either positive or negative pressurisation, CleanCube Pharma can be used in pharmaceutical compounding and Cell & Gene Therapy, especially where segregation and containment is required.

CleanCube Equip adopts a Maxi base (40ft doubler container) and has been configured to maximise processing space to accommodate large tools and equipment.

Typically, these modules are procured by tool and equipment manufacturers who form only a part of their clients manufacturing chain and their equipment must be operated within a controlled environment.

Guardtech have worked with OEMs to produce a standardised base unit that facilitates maximum floor space, supported by personnel and materials airlocks and supporting plant and utility zone.

Equip provides/has increased internal clearance of 2.5m by delivering ISO7 classified filtration via horizontal airflow and is temperature and humidity controlled to support process, packaging and storage conditions as well as operator comfort.

The Bio version, which initially became established during the pandemic, shares the same specification as many of the units out in the field right now that have become so vital for PCR testing.

These biosafety laboratories (levels 1, 2 & 3) are specially configured to ensure operators can work with contagious materials safely and effectively. These labs are designed not only to protect operators from contamination, but also to prevent micro-organisms from entering the environment.

GRADE D CLEANROOMS

The 150sqm Grade D cleanroom suite is for a bespoke clinical trial manufacturing service – including placebo manufacturing, clinical packaging, supply chain solutions and formulation development. The 400sqm Grade C and D project is for Cell & Gene Therapy.

ISOPOD CONFIGURATOR

Commercial director, Wheeler, wanted to capture the cleanroom ordering process in the most efficient and formulaic way he could. He broke down all the different elements that go into a modular cleanroom build and created a bespoke online tool to help streamline what can sometimes be a really convoluted, messy series of conversations – literally (and often) a cleanroom sketched on a scrap of paper!

The plan will be to open CleanCube and Isopod up to the international export market.

Wheeler had used similar tech to order cars before and thought it could be used for a modular cleanroom.

A LOT HAS CHANGED IN THE PAST YEAR FOR GUARDTECH CLEANROOMS, MARK WHEELER, COMMERCIAL DIRECTOR, GUARDTECH, SHARES THE JOURNEY OF THEIR GROWTH

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In plastics manufacturing, downtime for a facility comes at a cost. And it isn’t cheap. Whether the cause is a planned shutdown for maintenance or an unforeseen closure due to contamination or equipment failure, any lost time should be minimised as much as possible as the impact can be far-reaching.

From labour costs, including outside contractors and idled operators, to production costs, including wasted product and materials— downtime can seriously affect overheads. Through design, effective maintenance, and calibration, downtime can be reduced so that only the minimum time to maintain, test, and requalify the facility is required.

CONTAMINATION CONTROL STRATEGY

The use of a Contamination Control Strategy (CCS) will effectively define critical control points that could po tentially result in the contamination of a facility, and how these points can be assessed. By correctly implement ing a CCS, the risk of downtime due to contamination will be greatly mini mised. From the first steps of design to the procedures introduced and operator competency, a CCS should be used through the full lifecycle of the cleanroom. Controls may be implemented through cleaning pro cedures such as rotational cleaning, the use of continuous monitoring, or staff training.

HOW DESIGN AFFECTS DOWNTIME

The reduction of downtime starts earlier than you think in the lifecycle of the cleanroom. Future maintenance, service, and validation must be considered during the initial design of the facility. Downtime-

reducing measures include designing a layout that allows engineers ease of access to critical systems that make up the cleanroom, or using systems that can be replaced and tested without breaking the integrity of the cleanroom.

During planned shutdowns of the facility, routine checks of the HVAC system—and any other systems required to support the use of the cleanroom—are checked. If the facility has been designed to allow easy access to these systems, engineers will be able to work efficiently, without obstructions slowing down the process.

The ability to segregate zones of a facility, to allow maintenance in one area while carrying out routine operations, will greatly reduce the impact of a shutdown. The use of decentralised air handling systems provides the option to shut down sections of the facility while maintaining routine operations in others. If there is suitable space, segregated change areas for each area will allow staff to enter and leave rooms that are still in operation, while other areas are down. Traditional AHU’s service the whole facility so it’s much more difficult to shut down separate zones.

PLANNED PREVENTATIVE MAINTENANCE (PPM)

Incorporating PPM into your maintenance schedule should result in a reduction in downtime. The concept of PPM means shifting from a run-tofail strategy, to proactively seeking the prediction of required maintenance. Even when a facility is functioning normally.

In cleanrooms, PPM usually begins with monitoring. The use of routine or continuous monitoring of your facility is critically important to maintaining operations in a cleanroom. Not only will continuous monitoring pick up any out-of-specification results, such as high temperatures or increases in particulates, but the data can be analysed to determine any potential trends that may result in significant downtime to remedy. A shorter preventative

SIMON RICE, GMP VALIDATION & QUALITY CO-ORDINATOR AT CONNECT 2 CLEANROOMS, SHARES HOW TO REDUCE DOWNTIME DURING TESTING, MAINTENANCE AND CALIBRATION PERIODS FOR PLASTICS MANUFACTURING

downtime to remedy the change in results would be preferable over a full failure of the system, which could result in a significantly longer shutdown.

EQUIPMENT CALIBRATION

Routine continuous monitoring of a cleanroom usually requires supplementary monitoring systems to measure the environment of the room. Whether these are temperature and humidity data loggers or a particle counter, there is a requirement for these systems to be regularly calibrated to ensure the accuracy of the results generated. Without calibration, incorrect results may not flag potential issues which could result in facility downtime.

The calibration of equipment may result in site downtime if it is not planned for. For example, if a particle counter is required to carry out operations, and it is off-site for calibration, the cleanroom cannot function. There are several options to counter this potential situation:

Purchasing spare equipment will allow for equipment to be sent off-site for calibration without impacting operations. There will be an initial outlay of expense with purchasing a second unit, but the benefit of keeping the facility operating should outweigh the initial cost of purchasing and maintaining spare equipment.

Using a local calibrations service will prevent additional delays in downtime. Transit of the equipment and delays in customs can take up a large time that equipment is off-site, so by carrying out calibration in the UK the impact of equipment being off-site and therefore potentially resulting in downtime is minimised. The risk of damage to potentially expensive equipment is also minimised.

If possible, using a loan piece of equivalent equipment provided by the company that is calibrating the equipment may be the best option to prevent downtime. There would be no requirement for purchasing additional equipment, and if the loan equipment is delivered before shipping the equipment for calibration, there should be no impact on operations.

IN-HOUSE OR INDEPENDENT TESTING?

The use of a combination of third-party and in-house validation and testing can combine to produce counter-measures to site downtime. By using inhouse testing and monitoring, swift responses to any problems that may have occurred can be logged and actioned. Staff who regularly work in these areas are likely to spot potential deviations early on, and with an efficient system to capture these faults, they may be fixed before any room downtime is required.

The use of third-party validation and testing will provide a more independent and thorough test of the facility than can be achieved through in-house testing. Requalification of a cleanroom at regular intervals, whether determined by regulatory bodies or internal risk assessments, will assure that the cleanroom is operating within the expected acceptance criteria, and if any failures are observed, investigation and remedial

work can be carried out by trained staff to reduce the impact on routine operations.

Through a holistic and proactive approach to monitoring and maintenance, you not only gain better visibility of the operations of your facility, but you can raise productivity and cut back on costly downtime.

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Solutions for life

Raumedic develops solutions for life. Together with its customers, the medical techno logy company is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, Raumedic focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care.

COMPAMED AND MEDICA MAKE THEIR RETURN TO THE MESSE DÜSSELDORF THIS NOVEMBER WITH A MULTITUDE OF FORUMS FOR VISITORS TO JOIN.

Compamed and Medica, the medical shows that combine together to bring people from all sections of the industry to Düsseldorf. Whether you’re a manufacturer, designer, tester, or supplier, there’s something there for you.

During the 4-day event, there will be several forums for visitors to enjoy. While the topics are said to be complex, the presentations will be short and easy to understand.

COMPAMED

Almost 700 companies from 36 nations will take part. Compamed will have two integrated forums – the High-Tech Forum and the Suppliers Forum.

The High-Tech Forum will have an inside look at current research and development phases of the processes and products presented at the event. There will be a focus on new materials, production techniques and more, being presented by specialists and experts.

The association responsible for the High-Tech Forum, IVAM, also organises the shared booth and the product market “High-tech for Medical Devices”. The IVAM area will host almost 50 companies and institutes from nine nations. Microcomponents, sensors, actuators, coatings and manufacturing procedures are just a few of the themes expected to be seen in this section.

The Suppliers Forum presents current developments along the entire process chain. There is a focus on mechanical and electronic components. The main topics of interest are additive manufacturing, electronics, regulatory affairs, cyber security and wearables.

At the Suppliers Forum, Dr. Andreas Hogg, Coat-Z CEO, will share information about their casing technology and the protection of critical components inside wearables.

MEDICA

The Medica Labmed Forum will return as an in-person meetingpoint again this year, after having to be on a digital platform in 2020 due to the pandemic. The two organisers, Professor Dr Georg Hoffman and Prof Dr Stefan Holdenrieder have put together a total of eight sessions this year.

The opening day will have a regulations and quality theme, which will be dedicated to the European In-vitro Diagnostics Medical Devices Regulation (IVDR). Prof. Dr Matthias Nauck, Greifswald University Department of Medicine, will present the first steps in quality assurance methods.

The second day, “trends in laboratory medicine”, will see a session on new insights in circulation nucleic acid diagnostics, led by Prof. Dr Stefan Holdenrieder. Dr. Abel Bronkhorst, Technical University of Munich, will discuss the newest discoveries within the basic science of circulating nucleic acids. Following this, the varied uses for clinical diagnostics will then be discussed by experts.

will be based around laboratory

introduction to high-throughput sequencing in Prof. Dr Jonathan new?”

The final two days of the forum will be based around laboratory medicine and life sciences. On the Wednesday, there will be an introduction to high-throughput sequencing in Prof. Dr Jonathan Schmid-Burgk’s lecture of “Nextgeneration sequencing – what’s new?”

There are several lectures throughout the final day for visitors to watch out for. One lecture, by Dr. Janine Altmüller, will offer an introductions into the technological concepts for single-cell and spatial analysis and share their effects by presenting several case studies.

throughout the final day for visitors

ExtrudingTRUTHthe

COMPLEX REQUIREMENTS, USERFRIENDLY SOLUTIONS

Process engineering know-how and materials expertise are crucial to any project from the beginning. For the past two years, Daniel Mielert has led a team of eight in customer drug-delivery projects, an important market for the medical and pharmaceutical industry, in part because more than 537 million people worldwide now suffer from diabetes.

As human life expectancy increases, so does the incidence of many chronic diseases. In hospitals, nursing care or home care, subcutaneous administration of medications is increasingly used where people need long-term or permanent drug therapies such as insulins, heparins, cytokines, interferons and immunomodulators, EPO or allergen extracts for hyposensitisation. Subcutaneous drug administration is considered to have few complications and to be gentle on patients.

A VERSATILE PRODIGY FOR MODERN DRUG-DELIVERY SYSTEMS

Coextruded tubing has a minimum internal diameter of up to only 0.1 millimetre and is indispensable in many drug delivery systems.

Depending on the application, it may have layers introduced during

manufacturing — a process known as composite tubing extrusion — to improve the functionality and safety of the injection system.

Here, the outer layer connects the coextruded tubing to other components of the fluid outlet such as the needle insertion system, reservoir or pump unit. The tubing and all connecting joints must withstand pressure of up to six bar. The inner layer is inert, thereby ensuring marginal interaction with the drug throughout the product’s life cycle.

Properties like these make coextruded tubing an important component of the fluid outlet, the heart of any drug delivery system. Raumedic not only designs and adapts the tubing for individual systems, it also intelligently combines various manufacturing processes.

SMART COMBINATION OF PROCESSES AND TECHNOLOGIES

“The complex requirements of modern medical technology, in particular in drug delivery, call for intelligent process combinations,” Mielert says. “Longterm applications, safety and reliability for home-care use, miniaturisation and greater user-friendliness all mean challenges in developing and manufacturing drug delivery systems. All the components have to dovetail reliably.”

There is customised know-how in every phase of a development project along with the constant pursuit of the optimal complete system — from the first sketch and initial 3D models for rapid prototyping all the way to final specifications.

“We observe the market and see the difficulties that can arise when components come from different suppliers and must be assembled into an overall system,” Mielert explains. Often, the components or materials are incompatible. The result can be additional corrections, a need for optimisation or even costly design or concept changes. That costs time and money unnecessarily – a powerful argument given rising costs and deadline pressures in healthcare, especially in light of the acute energy debate.

“We consider the whole system right from the start: We find individual solutions for every requirement, no matter how complex,” Mielert says. This not only saves time and money, it minimises risk: Individual components are developed, manufactured and validated by an experienced expert.

INDIVIDUALLY DESIGNED SOFT CANNULAS

Raumedic has demonstrated its expertise in combining technology and materials. This includes integrating soft cannulas into the fluid outlet of patch pumps.

The cannula replaces the classic steel injection cannula and remains inside the patient for the duration of the application, enhancing comfort and drug delivery.

With an assembled solution, the highest quality standards for materials, geometry and dimensions can be realised in the extrusion process, offering possibilities when post-processing extruded tubing to expand the assembly into customised soft cannulas. Alternatively, injection moulding reduces the number of steps because both the cannula shaft and the housing are produced from a single mould.

DANIEL MIELERT, HEAD OF PRODUCT DEVELOPMENT FOR INJECTION & DOSING DEVICES AT RAUMEDIC, DISCUSSES THE FUTURE OF DRUG DELIVERY FROM DETAILED COEXTRUSION TO A COMPREHENSIVE SOLUTION

ALEX KAKAD, GLOBAL PRODUCT MANAGER FOR TEKNIPLEX HEALTHCARE, HIGHLIGHTS THE WAYS TO AVOID COMMON PARATUBING ISSUES

Also known as peel-apart tubing, paratubing entails a set of tubes bonded to remain bundled together until device assembly, patient care, or other pre-determined point of separation.

For medical devices, among the more sensitive risks is loss of suction during a procedure. Proper and consistent vacuum levels for fluid or mass removal are a critical factor in many application areas.

The other application factor of high importance is adequate and constant anaesthetic or medicinal delivery. Disruption of an anaesthetic agent can be painful and even dangerous for a patient, while insufficient medicinal supply caused by a tubing line leak could render a procedure ineffective or even harmful.

Considering all this, it is paramount that a paratubing assembly-based solution have a validated, consistent manufacturing process behind a welldesigned and robust product solution.

Let’s explore.

MIXING AND MATCHING

Many medical devices must incorporate multiple single-use tube lines, each of which supplies or removes a different fluid or gas. In addition, some of these devices also require a separate power line to provide a light source. A paratube makes it possible to combine these tubes into a single structure that is significantly easier for clinicians to manage.

In this landscape, versioning is the surest path toward safety and success. To minimise risk during medical procedures requiring multiple lines to deliver fluids, gases, suction and power to the same application space, a custom design may be recommended or even necessary to best ensure proper line connections.

Tubes can be composed of differing compounds engineered to accommodate the fluid, gas or suction it provides, and tube ends can be separated to ensure efficient and secure bonding into connecting ports. Some advanced tubing manufacturers, such as TekniPlex Healthcare, can even produce configurations of up to eight tubes in eight distinct colours, bonded together in a single device solution.

But of course, matching the right tubes to the right ports isn’t the only challenge associated with paratubes. Several other pitfalls may arise far upstream from patient care, in the production and inspection processes.

SEPARATION ANXIETY

Paratube production is far from simple, presenting opportunities for several unacceptable issues to arise.

For starters, there’s a “Peel strength Goldilocks Zone” – a sweet spot that must be maintained throughout the manufacturing process to best ensure paratubing efficacy. On one end of the spectrum, to avoid premature separation it is crucial that tubes maintain a consistent bond, which typically requires a minimum 0.22 pounds of peel strength.

On the other end, bond strength must not surpass 1.5 pounds of peel strength at any spot otherwise, mission-critical damage can occur to one or multiple tube lines.

production line speeds.

Fortunately, some of the resulting product problems are instantly obvious. Among the more catastrophic issues with paratubing design occurs when the bond strength between two tubes goes beyond 1.5 pounds of pull force. In this scenario, significant portions of adjacent tube walls can stick to one another upon separation, causing improper mating connection. This insufficient fitting attachment adds to the risk of a fluid path leak or loss of suction in the application.

Other issues associated with excessive bond strength are less noticeable but nonetheless vital. A more subtle failure can occur if non-uniform bonding between tubes leads to smaller markings (chatter marks) or void spaces on an individual tube. While large portions of a tube wall sticking are more recognisable and therefore likelier to be caught during inspection, smaller chatter marks are more difficult to identify but can lead to process leaks all the same.

This outlines the importance of maintaining proper process controls and inline testing to ensure uniform, repeatable, and consistent peel strength, as well as inner and outer diameter tolerancing on individual tubing lines. Such rigorous process controls significantly improve the likelihood that products received during design stages will be representative of those produced at high-speed, full-scale manufacturing.

A COHESIVE SOLUTION

Solutions must maintain a consistent bond between 0.22 and 1.5 pounds of pull force – and be able to do so at high speeds. As with many medical device manufacturing scenarios, quality control becomes far more challenging as production scales up and speeds up.

manufacture paratubes. All setups have their own

There are two distinct bonding methods – thermal and chemical – and various die configurations utilised to manufacture paratubes. All setups have their own subsets of challenges that often come to light only when the application moves to full-scale production – a result of inadequate steps toward ensuring product consistency at higher

For that reason, it is absolutely necessary for paratubing manufacturers to impose a strict policy of full validation for both bond strength and inner and outer dimension (ID & OD) consistency.

MEDICAL DEVICE COMPONENTS THAT INHIBIT BACTERIAL GROWTH

Vyon porous plastics from Porvair Sciences are the perfect material for filtration applications in the healthcare and medical device market.

The tortuous path of Vyon porous plastics make these materials particularly effective at bacterial filtration and preventing microbial ingress. Manufactured to a variety of pore sizes and thickness, Vyon porous plastic materials can also be used to filter out a wide variety of different contaminating particles.

Employing a standard procedure, based upon ASTM F2101, Porvair

Sciences can manufacture for OEM partners - Vyon porous plastic filters for incorporation into a medical device that offer greater than 99% Bacterial Filtration Efficiency (BFE).

Porvair Sciences is a leading OEM supplier of pipette tip filters that are highly effective at inhibiting bacterial growth as well as being fully compliant with FDA, USP Class VI and European Pharmacopoeia statutory regulations. For further information please visit https:// www.vyonporousplastics.com/pipettetip-filters/ or see us at Compamed 2022 (Stand 8AF08).

To discuss development of a porous plastic component for your medical device that offers high bacterial filtration efficiency please contact Porvair Sciences Ltd on +44-1978-661144 or enquiries@ porvairsciences.com.

www.vyonporousplastics.com

CASHING IN

Post-COVID, there was a huge surge in demand for respiratory care devices to meet the demands of the clinical establishments with many new players coming to the market with solutions, but the progression beyond that has been to make the devices lightweight, portable, and suitable for residential use, with the commercial constraints of being profitable in a crowded space with many constituent parts being disposable.

With the book being opened on the designs, new technology had a chance to be integrated and embed functionality into the devices which may not have previously been necessary. To capture any data for analysis, if a patient is breathing through a mask their inhale and exhale volumes can be monitored through tracking changes in the differential pressure of the patient breathing. With the patient breathing being captured as ‘data’ this can be set to trigger an alarm if there are unexpected changes, or to present a captured profile of breathing at a clinical review.

If the health indicators can truly be captured and considered as data, then it is not limited to respiratory care as similar principals and advancements are being made throughout the full industry as the level of trust in technology improves. Capturing deviations or changes can be as accurate as 60mbar, so this methodology can lend itself to extended fields like blood pressure analysis, heart rate monitoring, brain impulses for epilepsy diagnosis and negative pressure therapy wound recovery acceleration.

The technology improvement goes beyond the biometric data that a patient will generate, but it can be seen in the advancements in how care is administered. The data that a patient generates can be the ‘output’, but what about the ‘input’? Where supplementary care needs to be administered, this can also be tethered through IoT systems and loop into the symptoms the patient demonstrates.

Medical technological advancement will no doubt require multiple disciplines to deliver a robust solution for such a tightly regulated field. No unnecessary risks can be taken and a MTBF rate could be the difference between life and death. The decision to develop a new offering to the medical market can be off-putting when you consider the time, effort and expenditure that would be required to meet the guidelines within a high cost of failure environment.

Even from the example to the breathing apparatus with IoT connectivity you need a range of disciplines either from your own team or from specialist subcontractors. It needs electrical and electronic engineering for the operation and data gathering, software developers for the data connectivity and control parameters, mechanical engineering for the air flow, and most critically a medical input to ensure that the product is fit for purpose and can effectively function to support the patient.

These activities can be considered as prohibitive overhead costs as it is going beyond the normal working practices to find new, effective,

sustainable solutions. As a means of support for innovation in the United Kingdom, where development has taken place there is help through HMRC to soften the blow of that expenditure.

Where development has been applied, there are mechanisms available through tax rebate to claim back some of the outlay. This can apply to expenditure right from the beginning of the pre-planning stage through to the release and implementation to cover a portion of team wages, consumables, the cost of prototyping and for the cost of the specialist sub-contractor inputs that may have been required to give you the performance levels required.

DEVICES FOR MEDICAL TECHNOLOGY ARE ONE OF THE FASTEST PACED AREAS OF PRODUCT DEVELOPMENT. JAMES MACDONALD, TECHNICAL MANAGER AT ZLX, SHARES WHAT SUPPORT MECHANISMS ARE AVAILABLE

To remain competitive, manufacturers in the medical industry need to produce more goods, to higher quality, in less time. This is hard to achieve with human personnel alone, especially given the current skills shortage. The way to resolve these pressures is through automation –using robots to do the monotonous and dangerous jobs and freeing up workers to complete more valueadded tasks.

Although the UK was slow to the robotics revolution compared to many other industrialised nations, robotics and automation specialist FANUC UK is reporting an uplift in enquiries across the UK and Ireland, and especially from SMEs who have not, historically, been major users of automation. One of the factors helping to make automation a more attractive option than ever before is connectivity.

DRIVEN BY DATA

Machine tools and robots are becoming more intelligent. Industry 4.0 means that all devices in the factory are interconnected. An inevitable consequence of this is a trend towards standardisation of CNC applications across a range of manufacturing technologies. At the same time, availability of data from machines in operation, in real time, is helping to improve quality, reduce

unscheduled stoppages and boost productivity. These things are in reach of even smaller companies.

DIGITAL TWINS

Digital twinning is another trend that is proving beneficial to larger and smaller medical manufacturers alike. Developed in conjunction with a physical system, the digital twin can help firms that are looking to scale up, alter or enhance their production lines. By running a virtual version of any changes through the digital twin, they can have confidence that their automated system can handle them before investing in any new equipment, boosting uptime and eliminating the risk of ending up with a system that is not fit for purpose.

PRIORITISING FAT

Another factor to take into consideration when integrating any new smart manufacturing solution into your production line is the Factory Acceptance Test (FAT). FANUC UK had noticed that many of their customers lacked the technical expertise to complete Factory Acceptance Testing themselves, delaying installation and commissioning. FANUC UK has therefore developed its own in-house Factory Acceptance Testing facility at its headquarters in Coventry. Launched in June 2022, the FAT unit was constructed using ultra-hygienic cleanroom materials and encompasses a total area of more than 200m.

“As a result of growing global supply chain issues, we noticed that many of our customers are bringing their manufacturing processes back to the UK, after years of relying on production capabilities in the Far East, Asia or Eastern Europe,” says Dave Raine, FANUC’s ROBOSHOT manager for the UK & Ireland.

“However, after offshoring their manufacturing for so long, many have not managed to retain members of staff with the process validation, project management, technical compliance and robotics integrations skills required to complete in-house Factory Acceptance Testing when purchasing a new, smart, injection moulding machine. This is only being compounded by the post-Covid labour crisis currently facing the sector.

“Without the required skill set, plastics manufacturers run the risk of prolonged downtime and incorrectly specified machinery, both of which can seriously impact their bottom line. In response, we have developed our own, dedicated on-site FAT facility specifically for our injection moulding clients. Here, they can take advantage of our best-in-class validation and certification expertise, safe in the knowledge that their machine will operate exactly as required, and to the necessary industry standards, from the moment it is delivered to their factory.”

TOM BOUCHIER, MANAGING DIRECTOR, FANUC UK, DISCUSSES CONNECTIVITY AND HOW IT’S OPTIMISED FOR THE DIGITAL AGE

Medical diagnostic equipment & biotech applications

NEW SLEEK DESIGN FOR YOUR CLEANROOM APPLICATIONS

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ALBIS offers the medical industry an unparalleled choice of high performance polymers from renowned producers. This offering is complemented by customized polymer compound solutions tailored to customer’s needs and made by ALBIS’ sister company MOCOM.

We support numerous projects in the medical and pharmaceutical sector as well as for diagnostic equipment and biotechnology applications.

Addressing the latest trend towards an increasing use of sustainable solutions our portfolio includes newest and state of the art sustainable polymers which are specifically developed to fulfil the strict regulatory and service needs of the healthcare industry.

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Enrobe the microbe

Silver ions also cause an increase in reactive oxygen species within the cell, leading to various mechanisms of cell damage and impairment of cell processes.

When infused into a product, the AM additive will work continuously to make that product not only more hygienic by minimising the potential for cross-contamination, but more resilient as it defends against microbes that cause material degradation, extending a product’s functional lifetime. This technology can be formulated into a concentrated powder, liquid suspension, or masterbatch pallet.

WHY YOU SHOULD CONSIDER AM TECHNOLOGY

In recent years, there has been a rise in demand for antimicrobial protection to meet ever increasing hygiene standards within the medical industry. The UK’s National Health Service (NHS) has updated their cleaning standards to a three-stage audit: technical, efficiency, and external. Subsequently, the demand for antimicrobial technology is increasing within medical sectors.

For over 25 years, BioCote has been combining antimicrobial technology into a wide range of products. BioCote technology is integrated into products to reduce microbes such as mould and bacteria by up to 99.99% within 24 hours, minimising cross-contamination and making products easier to maintain and clean without the use of harsh chemicals.

An antimicrobial (AM) is something that can resist, inhibit, and prevent the growth of microbes. The technology is built based on the properties of antimicrobial materials that are formulated into a range of additives. The AM technology can then be integrated into a product during the manufacturing process.

The additives will encompass a specific antimicrobial activity and are tailored for specific products depending on the formulation of the targeted material and manufacturing process.

When in contact with microbes, silver ions damage DNA by blocking the copying of their genetic material, which stops the cells from being able to replicate.

Medical devices and equipment containing antimicrobial technology have a range of benefits specific to the quality of additives supplied, where some bacteria strains cannot survive on protected surfaces. AM technology supports the production of superior quality, high-performing, and hygienic products. Additionally, antimould technology can minimise growth of a wide range of unpleasant moulds.

Antimicrobial technology works to strengthen cleaning regimes that are in place at hospitals, medical centres, and clinics. It is extremely adaptable and can be added to any material at any stage of production. There are additives that are effective against antibiotic-resistant strains of bacteria, which helps to achieve the ultimate hygiene solution for the healthcare sector.

INTEGRATING AM TECHNOLOGY IN MEDICAL DEVICES

Integrating antimicrobial technology into medical devices and equipment can kill microbes and reduce cross contamination, improving the durability of products. This is achieved because AM technology ensures that the product is less susceptible to microbial growth. Due to the control of microbes that reduce potential material degradation, devices become more durable, and equipment effectiveness is maintained.

Healthcare facilities can make a difference by incorporating products with antimicrobial technology for key touch point area such as door handles, grab rails, soap dispensers, and more as the technology not only lessens the potential of cross-contamination, but significantly reduces microbes to keep medical products more hygienic.

INTEGRATING ANTIMICROBIAL MASTERBATCH

Typically for plastic materials, antimicrobial additives are incorporated through masterbatch integration. The additive is encapsulated in the carrier material, allowing a seamless and stable process of dispersing the technology into a product. This can be applied to medical products such as respiratory disposables and aerosol products.

INTEGRATING ANTIMICROBIAL POWDER

AM powder is widely used in paints and coatings and can offer builtin protection for the exterior of a product to add enhanced hygiene performance. Products such as hospital bed handles, bathroom safety fixtures, and tray storage have had the application of BioCote antimicrobial technology.

HANNAH MULLANE, SOCIAL MEDIA AND CONTENT EXECUTIVE, BIOCOTE, EXPLORES INTEGRATING ANTIMICROBIAL TECHNOLOGY INTO MEDICAL DEVICES FOR PRODUCT ENHANCEMENT

TAKE A EEK

WOLFRAM HASERT, SENIOR EXPERT TECHNICAL SALES AND MEDICAL APPLICATIONS, LEHVOSS GROUP, SHARES HOW COMPOUNDERS MAKE THE LIVES OF PATIENTS, DOCTORS AND PRODUCT DEVELOPERS EASIER

Helping people improve their health is multi-layered teamwork. In the field of sophisticated medical technology, this comprehensive spectrum also includes all people who provide the right high-performance plastics for the development of this technology: the plastic compounders who ensures the optimal composition/performance of the required materials.

Even if the patient’s well-being is at the centre of all work and activities, the primary goal of the compounder is to make the work of the product developer or the processor or designer as efficient and successful as possible. Just as with any doctor from every conceivable specialty, four basic competencies are crucial:

• appropriate “instruments”

• extensive specialist knowledge

• the high art of attentive listening

• many years of experience

activities, the primary goal of the compounder is to make the work of be

Only in this way can challenges and any problems be fully penetrated and developments or possible solutions can be approached and implemented in a promising manner. Regardless of whether these are located very close to the patient (such as a retractor or an endoscope handle) or further away (such as a sterilisation container).

Regardless the

On the one hand, they know about the performance of the amorphous/ semi-crystalline highperformance plastics, and, on the other hand, knows both the requirements of the users and those of the processors.

Above all, however, they know from their experience that even the most advanced material development alone does not produce an innovative medical technology

Much more is needed for this.

such as PEEK,

The LEHVOSS Group has been a partner for medical device manufacturers since the 1980s and offers a variety of polymers including customised materials. These include coloured, laser-markable and theologically optimised materials, structural and mechanical materials with glass fibre and carbon fibre reinforcement, powders, filaments and granules for 3D printing. For applications in medical technology the focus is on high temperature / high chemical resistant materials, such as PEEK, PEI, PPS, PPA and PPSU.

Whether retractors, endoscope handles or sterilisation containers – high-performance plastics basically go along with every development step. A good compounder combines all this in one.

further development/production process does it become clear

Regardless of whether materials based on PEEK, PPSU, PPA, PA 66 are modified with carbon or glass fibres and additives – only in the further development/production process does it become clear whether the materials behave under the influence as all participants hope or as they expect.

The high-performance compounds

The high-performance compounds offer perfectly matching material solutions for a wide range of requirements in the field of medical technology.

Conclusion: It’s like the relay race –the interface counts.

Even the highest speed of the individual runner is of no use in a relay race if the handover of the baton is not well rehearsed. In a figurative sense, this also applies to the cooperation between the compounder with its highperformance compounds on the one hand and the product developer on the other. The more long-term, competent, intensive and detailed the transfer of know-how can be carried out by both sides, the sooner a new product development achieves its goal or the more continuously and stable a development/ optimisation/ production process can take place at a consistently high level of quality.

Dealing with the climate crisis requires commitment from multiple stakeholders. From governments and industry, down to businesses and individuals – it is essential that all those involved in action are moving in the same direction. The healthcare industry’s climate footprint is equivalent to 4.4% of global net emissions, and this cannot be addressed without setting clear targets and taking concrete action. Sustainability within the medical device industry is particularly challenging since it is imperative not to neglect infection control.

The climate crisis is changing our industry landscape and altering how leaders are approaching strategy, infrastructure, and the futureproofing of their businesses. Approaching sustainability is a nuanced and complex process, but fundamental to the evolution of the medical device industry as it keeps pace with technological, political and social transformation.

B CORP

The B Corp process demands that applicants complete a rigorous assessment of over 250 questions in multiple areas, going beyond environmental commitments to review overall governance, treatment of workers and customers, and contribution to the community. The comprehensive process provides a blueprint for companies to demonstrate greater responsibility across their entire business, and to apply growth and profit to the positive gain of the environment, employees and external communities.

Working towards B Corp certification in 2021 helped to

GOING THE GREEN MILE

retain focus on our goals and to consolidate and measure our progress. In a heavily regulated industry, this approach suited us well since we were already used to being audited for the quality and safety of our products.

ENERGY USE

By taking responsibility for our emissions footprints, we also protect our longevity as a business by developing sustainable structures, and by keeping up with global and national targets. Reducing energy consumption, for instance, leads to wider commercial benefits by reducing overall costs or improving efficiency of machinery in the process. Owen Mumford have established energy reduction initiatives across global operations in the UK, the USA and Malaysia, reducing our Scope 1 and Scope 2 carbon emissions by over a quarter; this covers both direct and indirect emissions from energy use. All our UK sites are now predominantly powered by renewable sources, including energy we generate ourselves via our on-site solar arrays. These initiatives will help us to achieve net zero by 2045 – mirroring the UK NHS target.

DEVICE DESIGN

Safety is a fundamental aspect for all products, and there are strict limitations on the kinds of materials we can use for their design to ensure users are protected. However, if products are designed with sustainability in mind from the very beginning, it becomes easier to create devices with a lower footprint. At Owen Mumford, goals have been set to create products with an emissions footprint that is much smaller than for previous ranges. We are doing this by reviewing every element of the design and manufacturing process via lifecycle assessments, identifying areas of improvement that, when combined, aim to significantly reduce the overall cradle-to-grave footprint of the devices we create.

COMPANY BUY-IN

Strong sustainability policies require dedicated resource and alignment from all areas of the business. As we look ahead, it is likely that sustainability certifications will become essential for manufacturers, so futureproofing our operations now means we are prepared for these and better positioned to continue growing. This process of change only works effectively when the whole organisation is invested in the goal, so companies have a responsibility to communicate goals clearly and effectively and consider how they relate to wider contexts.

At Owen Mumford, the sustainability steering group incorporates members from across the business to build upon our sustainability strategy and measure progress effectively. This allows each department to bring their ideas to the table, regardless of their size and scope, to be considered for implementation and gives our associates a say in how we build our sustainability strategy. If done well, initiatives to strengthen environmental responsibility could futureproof our industry, motivate employees and encourage a newfound pride in the work they do and how it connects to the planet.

JESPER JONSSON, DIRECTOR OF MEDICAL DEVICES, OWEN MUMFORD LTD HIGHLIGHTS THE IMPORTANCE OF SUSTAINABILITY IN THE MEDICAL SECTOR

Exhibition

Approaching Sustainability In Healthcare

The healthcare industry is estimated to be one of the biggest CO2 emitters, responsible for ca. 4,4% of total CO2 emissions globally. If it were a country, the healthcare sector would be the 5th largest greenhouse gas emitter in the world.

The aim, as well as the priority of applications in medical & healthcare, is to save lives, treat diseases and provide relief from pain. This industry is highly regulated with strict approval processes that avoid any comprise on the safety of human life or efficacy of the medical device. Accordingly, the development times of medical devices and pharmaceutical packaging can take many years, up to almost a decade. This brings further complexity to incorporate sustainability in this industry.

IMCD launched the Sustainable Solutions Framework, in which experts provide a tool to decomplexify the different approaches

to sustainability for the Advanced Material industry by breaking down the sustainable solutions into 8 categories: biodegradable, CO2 reduction, compostable, end-of-life enhancement, recyclability, renewable source, waste reduction and weight reduction.

For medical & healthcare applications, five categories apply: RENEWABLE RESOURCES

For medical device applications with strict regulatory requirements, a change in material would require recommencement of the time-consuming and costly approval process. Hence, drop-in solutions like polypropylene derived from used cooking oil could be an ideal option.

Similar to fossil oil, used cooking oil is broken down into its components on a molecular level. Due to this, PP derived from used cooking oil provides the same mechanical properties and maintains the same regulatory compliance as its fossil-based sibling. In order to track the whole supply chain of sustainable feedstock, IMCD is ISCC Plus certified and thus can carry out the massbalance approach.

RECYCLABILITY

For a product to be collected and recycled, the material selection is essential in the design stage taking also into account the intended use of this product. Choosing a mono-material solution can help to enable the sorting of the products. Especially for healthcare and pharmaceutical packaging, there is a trend towards these considerations, for instance by abandoning metallised plastics in blister or tube packaging and replacing this with PP, PE, COC or copolyester material solutions.

While mechanical recycling of plastics involves the re-granulation of material and maintains the molecular structure of the material, these products are not suitable for medical and healthcare applications because they lack medical approvals. During chemical recycling through the pyrolysis process, plastics are split into building blocks at the monomer level and can be used as feedstock to produce, for instance PP and PE. These can be considered as sustainable drop-in solutions for medical and healthcare applications as they offer the same technical specifications and medical compliances as their standard counterparts.

There is often concern about contamination of disposed products with infectious materials like blood. As not all plastic products which are disposed in a hospital are contagious, for instance syringe caps, establishing sorting infrastructure in hospitals could be one approach. But from the

JANA ZIETZLING, HEAD OF PRODUCT MANAGEMENT MEDICAL, IMCD, EXPLAINS HOW THE INDUSTRY SHOULD BE APPROACHING SUSTAINABILITY

regulatory point of view, the risk evaluation as well as the corresponding risk classification systems must be addressed first.

END OF LIFE ENHANCEMENT

In order to be safely reusable, the medical device must be capable of being appropriately reprocessed to remove contamination of microorganisms. A reprocessing in the medical and healthcare context could be disinfection or sterilisation of the device.

WASTE REDUCTION

Managing waste is a big challenge for the medical and healthcare industry. In addition to the options of closing the loop by recycling as well as designing medical devices for reusability, the industry also investigates another aspect:

With the increase of vaccinations and the further developments of parenteral drugs, the usage of PFS (prefilled syringes) is becoming more popular. Traditionally, glass vials were the first choice for providing drug products, but these are usually overfilled to make sure the full dose will be administered to the patient. Prefilled syringes can be made of COC, are easier and faster to handle, reduced in risk and have improved dose control so that they help reduce drug product waste.

WEIGHT REDUCTION

Reducing weight can be achieved by reducing the material in use. For instance, certain medical grades of PP, PMMA, or Copolyesters are available, which can be converted into devices with very thin walls due to their improved processability and flowability. At the same time, less energy is consumed, which further decreases the carbon footprint.

WHAT SHOULD WE DO TO BUILD A SUSTAINABLE FUTURE?

Plastic materials became indispensable in the medical and healthcare industry and are the base for developing and producing medical devices to save and

improve patients’ lives.

It is a highly regulated market segment in which patient safety, hygiene, and infection control play a decisive role. Additional complexity arrives with many players involved in this market often dependent on reimbursement schemes from healthcare insurance companies. This makes it difficult to find a one-fits-all solution in terms of the sustainability approach for medical and healthcare applications. However, one thing is for sure: a stand-alone approach of a single market player will likely not make the difference; it will require joint forces across the industry to achieve a “greener” segment!

Plastic Material Changes Require Latest Plastic Welding Technologies

Market pressures are driving medical device designers away from PVC and PC, yet replacements like PE and PP do not respond well to traditional plastic joining methods. Reliable assembly requires advanced BransonTM ultrasonic and laser welding systems from Emerson. They produce ultra-clean, aesthetically superior welds for today’s preferred materials while also delivering design flexibility, process efficiency, energy saving and sustainability advantages.

Learn more at: Emerson.com/Branson

Come and speak with an expert at: K-Show, Hall 11 Booth F55, 19-26th Oct 2022.

SHORTLY AFTER IT WAS ANNOUNCED THAT TEKNOR APEX RECEIVED THEIR +VANTAGE VINYL CERTIFICATION, MEDICAL PLASTICS NEWS CAUGHT UP WITH DEREK LAFFEY, MEDICAL INDUSTRY MANAGER FOR TEKNOR APEX, TO FIND OUT WHAT THIS MEANS FOR THE COMPANY

No sustain, NO GAIN

What does the +Vantage Vinyl verification mean for Teknor Apex?

Teknor Apex has long been an industry leader in innovation and sustainability and being a member of +Vantage Vinyl aligns us with like-minded organisations that further the sustainability of the vinyl industry. Companies that are granted use of the +Vantage Vinyl mark have undergone verification by third-party GreenCircle Certified to confirm their organisation’s progress compared to the programme’s guiding principles relating to environmental stewardship, social diligence, economic soundness, open communication, and collaboration. The initiative’s structure ensures that Teknor Apex is advancing the sustainability journey of the vinyl industry in alignment with targeted United Nations Sustainable Development Goals (UN SDGs).

What is Teknor Apex implementing to ensure the company is sustainable?

Teknor Apex is committed to the journey of corporate sustainability – it’s one of our core values — as a business partner, an employer, a community member, an environmental steward and a value creator for our stakeholders.

Every day we investigate new sustainable raw materials, processes, technologies and partners to deliver the most innovative solutions for addressing

a wide variety of performance and regulatory requirements.

Being good stewards of the environment means investing in initiatives to reduce the environmental footprint of our operations. A few recent activities of note are the 1 million Kilowatt-Hour Challenge, the installation of solar panels in several of our manufacturing facilities, the establishment of a green energy partnership in Singapore, and our global partnership with Operation Clean Sweep (OCS).

Social responsibility at Teknor Apex is something we take very seriously. While this duty effects everything we do as a company, we specifically strive to be good stewards in the following three capacities: As a manufacturer – to produce products that are safe for customers and consumers, as an employer – to provide a safe and healthy workplace for every single one of our employees, and as a member of the community –to protect the environment for ourselves and others, as well as for future generations.

What innovation has had to take place to make your existing products more sustainable?

We have consistently worked in partnership with our customers to innovate new products with more sustainable raw materials and efficient processes or introducing new technologies and recycling solutions.

Our Medical Grade Apex PVC and Flexalloy PVC Elastomers lead the industry on all fronts: non-DEHP plasticiser options, colour hold after Gamma and E-Beam sterilisation, and ultra-clear tubing and parts that result from decades of formulation and manufacturing expertise. They are formulated with FDA 21 CFR ingredients and are designed to meet a wide range of global sustainability and regulatory requirements.

Our compounds are formulated to be ADM compliant, BPA and LATEX free, and come with biocompatibility test data for USP CLASS VI and ISO 10993-5 Cytotoxicity.

Teknor Apex has supplied the industry for over 70 years, how has looking after the environment changed in that time? What factors do you have to consider now that you didn’t then?

Medical Device Manufacturers, as in other industries, are under increasing pressure from customers, regulators, governments, and consumers for more environmentally friendly products. As we formulate new compounds, we must consider the many directives on materials that regulators have deemed hazardous to the environment such as EU REACH SVHC, EU MDR, EU RoHS, and CA PROP 65.