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MOULDING MACHINERY THE CLEANROOM CONUNDRUM


With production space at a premium, medical injection moulding experts at Sumitomo (SHI) Demag - Andrew Sargisson, Regional Sales Director, and Sam Carr, UK Medical Business Development, share their cleanroom production insights


reating a cleanroom environment that meets GMP regulations can often be a cumbersome task for organisations within the medical moulding space. As well as being costly and timely to implement, regulatory compliance often results in the process becoming more convoluted than strictly necessary. The guidance, from Sumitomo (SHI) Demag, aims to help keep the process simple by utilising technical expertise and knowledge.


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In the latest 2022 report curated by Data Bridge Market Research, the global cleanroom technology market is anticipated to grow to USD4.25bn by 20291


. Driven by a surge in


demand for high quality medical applications compliant with regulatory standards, control variables, including air flow, humidity and temperatures, are all essential considerations. There are three critical features that medical manufacturing cleanrooms must effectively observe and implement. The first of is that internal surfaces and equipment needs to be designed in a way that mitigates contamination and can be sanitised with ease. Furthermore, a source of filtered air flow is needed to effectively regulate temperature, humidity and air quality, while simultaneously extracting particulate contaminations. Introducing robust operational and maintenance procedures and ensuring staff are fully trained is equally critical. The cost of building a cleanroom means investment decisions aren’t taken on a whim. Most medical moulders will only embark on cleanroom projects to fulfil regulatory FDA, GMP Annex 1 and CFR Part 211 requirements. In order to comply with these requirements, the equipment used in the manufacture, processing, packing or holding of a drug product needs to be of an appropriate design, adequate size and suitably located. The choice of moulding machinery selected


46 APRIL 2023 | PROCESS & CONTROL


for cleanrooms is generally customer-specific. Where medical components need to be manufactured and packed in a self-contained cleanroom environment to meet ISO Class 7 or 8 standards and comply with any GMP Annex 1 and FDA regulations, a fully configured all- electric injection moulding machine can be a straightforward way to eliminate the biggest contamination risks … people.


That’s because the exposed points where a plastic component may come into contact with the environment are all enclosed. For that very reason, virtually every global cleanroom project undertaken by the medical team now features an IntElect machine.


Andrew Sargisson stresses the need for organisations to keep things simple when it comes to commissioning moulding machinery for a cleanroom environment and cautions against over specifying superfluous equipment. This, he claims, is likely to create needless issues down the line. For example, focussing solely upon the cleanroom classification itself could leave medical manufacturers exposed to unwarranted compliance requirements that, once approved, they must continue to adhere to. Sometimes effective ventilation is all that’s required. Yet, for sterile medicinal products, the requirements - defined by Annex 1 of the EU and PIC/S GMPs – are even more stringent. This is where global expertise is a true


benefit. Out of regulatory fear, people may submit a user requirement specification (URS) request for a cleanroom solution that is excessive for the component being made. As a global medical team that works collaboratively across borders and are all GMP-trained, the group is able to pull in technical experts and provide high quality consultancy at the start of any medical cleanroom project. This makes it easier to manage defined steps for design, installation, operational and production Qualifications and Validations of cleanroom machinery.


As filtered air controlled production environments, moulding cleanrooms are energy intensive. Experts estimate that the air units that circulate fresh air and extract particulates can consume around 60 percent of all production power.


Saving energy is inherently challenging in cleanrooms given the stringent workflows to prevent pollutants spreading.


To counter any adverse impacts of the ensuing energy crisis, medical moulders may want to consider fully utilising any ‘white space’ inside their cleanrooms, occupying any extra space with additional machinery or equipment. The benefits of this are multiple, in that organisations can increase their operational capacity without the need to power or fuel additional space. Lower ceiling heights is another tactic to reduce the overall atmosphere that requires HEPA filter control. Even if the physical space remains unchanged, the reduced footprint of today’s compact all-electric machines now enables MedTech manufacturers to optimise their cleanroom envelope, boosting cost and productivity metrics considerably. Over-cluttering is not in-line with the GMP standards. Removing free-standing periphery equipment from the floor and integrating into the moulding machine cell, including hot runner controllers, cables, and automation, eliminates another surface area and additional sources of heat generation. Integrated electric direct drives is another consideration. The increased efficiency from these drives means that they use less energy – in the case of the IntElect between 40% and 85% less than conventional solutions. Having this level of drive control also makes a subtle difference to clamp force. Use too much force and the machine’s energy consumption rises. Rather than diverting straight to the maximum clamp force, a medical IntElect machine, with its smaller than average injection unit, can override and select


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