☣️ Cleanroom Control
Cleanroom Environmental Monitoring Limits
Assess cleanroom particle and microbial concentrations against EU GMP Annex 1 (2022) and ISO 14644-1 parameters. Input measured values to determine compliance status for sterile manufacturing environments.
Cleanroom Parameters & Measurements
Non-Viable Particulate Counts (per m³)
Viable Microbial Counts (CFU Limits)
Regulatory Limits & Verdict
Current Grade & State Thresholds
Particulate limit ≥ 0.5 µm
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Particulate limit ≥ 5.0 µm
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Air CFU/m³
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Settle CFU
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Contact CFU
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Glove CFU
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Enter environmental readings and click evaluate to assess cleanroom compliance.
Regulatory Context (EU GMP Annex 1 2022 Revision):
The August 2022 revision of Annex 1 implements stricter guidelines for environmental monitoring (EM). Non-viable particle limits match ISO 14644-1. Microbial limits for Grade A are strict: any colony forming unit (CFU) counts of 1 or more must trigger an immediate OOS/Deviation investigation, as the expected count in Grade A is 0.
The August 2022 revision of Annex 1 implements stricter guidelines for environmental monitoring (EM). Non-viable particle limits match ISO 14644-1. Microbial limits for Grade A are strict: any colony forming unit (CFU) counts of 1 or more must trigger an immediate OOS/Deviation investigation, as the expected count in Grade A is 0.
Evaluated By (QC Microbiologist):
Date:___________________
Approved By (Quality Assurance):
Date:___________________