FAQ - 製薬/生命科学（ライフサイエンス）における微粒子測定

LASAIR II-550L

質問 What is the particle count frequency for new facilities under validation?

回答

Essentially, you must certify the cleanroom every year and then monitor the cleanroom in accordance with the product risk.

Critical sterile products should be continuous in the Grade A. Terminally Sterilised products or Grade B of sterile products should be each shift/day and grade C and D areas are on a weekly / monthly basis.

For more information, read Particle Monitoring Requirements in Pharmaceutical Cleanrooms.

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