PHC Application Note: Cleanroom Guidelines

PHC Europe (PHCEU) has released a technical Application Note on the use of its incubation and cold storage solutions that are optimized to comply with specialized cleanroom environmental requirements.

The application note Cleanrooms, GMPs and ISO Certification provides guidance on the regulatory and certification guidelines that apply to use of laboratory equipment or  medical devices in cleanroom environments and that affect Good Manufacturing Practice compliance (cGMP) qualification.

It assesses threats to cell culture-based production that govern both cleanroom and equipment design and standards assessment.

ISO Classification

The particle sizes involved in escalating threats of contamination form the basis of the various ISO 14644-1 Cleanroom Classifications that are based on threshold of allowable particles within a specified area. These classifications range from Class 1.0  (the most demanding) to Class 9, with PHCbi incubators meeting Class 5 or Class 6 standards.

The application note explains how ISO cleanroom Classification has implications for GMP compliance.

The brochure also covers the basic disciplines of operating equipment under cleanroom conditions, including appropriate specification, attire, maintenance, inspection and testing.

It concludes by summarizing the pre-qualification testing regimes and methodologies for PHCbi equipment