CLEANROOMS
JENI THOMAS, CONTENT AND COMMUNICATIONS LEADER AT CONNECT 2 CLEANROOMS (C2C), AND ALISDAIR WATSON, MD AT OPTIMOLD LIMITED, EXPLAIN HOW MODULAR CLEANROOMS SUPPORT MANUFACTURING PROCESS CONTROL FOR MEDICAL PLASTICS.
Modular cleanrooms supporting PROCESS CONTROL FOR MEDICAL PLASTICS
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here are certain challenges that plastics manufacturers face when producing molded parts for medical devices. Controlling air quality with a modular cleanroom protects the production of medical plastics.
The injection molding process—in particular the material conveying equipment—naturally creates a degree of particulate contamination. When molded parts are removed from the tool, the type of polymer and the process can also generate static, even with the use of an antistatic device. When combined, the particulate and static can cause problems for manufacturers who have tight AQL (Acceptable Quality Limit) sampling requirements. This is why the manufacture of medical devices must be performed within ISO 14644-1:2015 Class 5 to Class 8 cleanrooms. CLEANROOMS AND PROCESSES ALIGNED TO CONTROL CONTAMINATION The way that the governing ISO standard looks at compliance is by minimizing the introduction, generation, and retention of particles. This can only be achieved through a partnership of cleanrooms and processes. Cleanrooms stop the introduction of contamination through HEPA filtration. Controlling the generation of contamination is then down to organizations’ SOPs, protocols, and process controls. The responsibility of controlling the retention of particles comes back to cleanrooms again as they effectively
flush that facility of contamination with appropriate air change rates. Optimold Limited, the sister company to mold manufacturer Microsystems (UK) Limited, is a contract manufacturer producing injection molded components for medical devices, such as autoinjectors, asthma inhalers, drug delivery and blood diagnostics for both hospital and laboratory use. Over the past decade, C2C has supported Optimold with modular cleanrooms to facilitate growth in the medical device market. STARTING CLEAN PRODUCTION To stay competitive, companies need to be able to incrementally grow their cleanroom offering in line with the growth of the company.
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