CLEANROOMS ACCORDING TO GMP MUST BE QUALIFIED AND CLEANROOM PROCESSES VALIDATED. THE QUALIFICATION IS THE DOCUMENTED PROOF THAT THE CLEANROOMS ARE SUITABLE FOR THE INTENDED PURPOSE

Cleanroom classes according to EC GMP guidelines, Annex 1 - new version 2020!

In the pharmaceutical industry and in the aseptic production of medicinal products, classification according to GMP guideline Annex 1 is common.

The information provided in the guidelines on monitoring contamination risks should be given due consideration.

The EC GMP Guideline, Annex 1, defines the limit values for microbiological contamination by microorganisms and particle count of the ambient air.

With the revised version of Annex 1, the 12th version was created in 2020. It emphasizes the importance and absolute necessity of a contamination control strategy. This annex contains general guidelines that should be used in the manufacture of all sterile products according to the principles of quality risk management in order to prevent any contamination in the end product.

In total, there are GMP cleanroom classes A, B, C and D. Class A is the highest and cleanest level, while cleanroom class D allows the maximum permissible particle concentration.

In order to operate a cleanroom class A, for example, all cleanliness classes must be complied with on the way there and may only be skipped under special conditions. This means that the cleanroom must first be designed and implemented from D to C, from C to B and finally to A.

Cleanroom class A is required for sterile filling, for example. On the way there, all cleanroom classes are usually passed through successively (and may only be skipped under special conditions). Personnel and material airlocks form the transitions between the cleanroom zones.

The classification of rooms according to GMP "Good Manufacturing Practice" is used in the pharmaceutical, biotechnology, medical technology, food and cosmetics industries.

Cleanroom qualification and validation includes comprehensive and high-quality qualification of all cleanroom equipment and systems in accordance with current guidelines, including comprehensive, complete and GMP-compliant documentation. This should work together like a pot with a lid.

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