Environmental monitoring: How to maintain a cleanroom

Your environmental monitoring (EM) program must demonstrate control over both viable and non-viable particles found in critical areas of your operation. The procedures and protocols you have in place must ensure asepticism throughout your operation. There are many complex ways of classifying your operation as aseptic. The methods used to reach a contamination-free environment, regardless of your industry or the size of your business, remain the same. These methods assist you with proving cleanliness, which is paramount when you are creating, testing or packaging medicines or substances destined for human contact or consumption. The EU’s Good Manufacturing Practice (GMP) regulations provide for systems that ensure processes and facilities are controlled and maintained for identity, quality, purity and strength. This means EM programs need to adhere to what the EU GMP outlines as best practice. The draft of EU GMP Annex 1 reaches further, to ensure patient and human safety through the implementation of stringent guidelines.

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