EDITOR ’ S CHOICE THE CLEANROOM CONUNDRUM
SUMITOMO
Guidance to support regulatory compliance , efficiency and best practice success
The Sumitomo ( SHI ) Demag global medical team ( L to R - Shota Takemura , Medical Team Japan - Anatol Sattel , Head of Business Unit Medical , Germany - Sam Carr , Medical Team UK - Andrew Sargisson , Regional Sales Director Business Unit Medical , based in Germany )
Creating 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 the global medical team at Sumitomo ( SHI ) Demag is to keep the process simple , and to utilise technical expertise and knowledge .
With production space at a premium , medical injection moulding experts at the firm - Andrew Sargisson , Regional Sales Director , and Sam Carr , UK Medical Business Development - share their cleanroom production industry insights , tips and the top trends shaping the MedTech cleanroom space .
In the latest 2022 report curated by Data Bridge Market Research , the global cleanroom technology market is anticipated to grow to USD4.25bn by 2029 . Driven by a surge in demand for high quality medical applications compliant with regulatory standards , control variables , including air flow , humidity and equipment temperatures , are all essential considerations .
MORE THAN A WHITE SPACE
There are three critical features that medical manufacturing cleanrooms must effectively observe and implement . The first of these requirements 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 .
Rising energy costs combined with the upfront costs of building a cleanroom means that investment decisions are rarely 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 .
26 PECM Issue 61