Cleanroom Classification: EU_GMP_ANNEX_1
Cleanroom classification data including ISO 14644-1:2015 particle count limits for Classes 1-9, air change rate guidelines, pressure differentials, temperature/humidity ranges, gowning requirements, and EU GMP Annex 1 (2022) Grade A/B/C/D records
| classification standard | record id | eu gmp grade | eu gmp state | gowning description | gowning level | iso class | monitoring frequency | particles 0 5um per m3 (particles/m3) | particles 5 0um per m3 (particles/m3) | pressure type | recovery time min (min) | rh pct max (%RH) | rh pct min (%RH) | standard | temp c max (degC) | temp c min (degC) | typical applications |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EU_GMP_ANNEX_1 | GRADE_A_AT_REST | A | at rest | Full aseptic gown; sterile gown and gloves; face mask or PAPR; goggles; shoe covers; gowning anteroom with interlocked doors | 5 | 5 | Continuous particle monitoring with alert/action limits; viable air and surface sampling | 3,520 | 29 | positive | 3 | 60 | 40 | EU GMP Annex 1 2022 (EudraLex Vol.4); ISO 14644-1:2015 | 22 | 20 | Aseptic filling; stopper handling; open sterile container closure; compounding in open containers |
| EU_GMP_ANNEX_1 | GRADE_A_IN_OPERATION | A | in operation | Full aseptic gown; sterile gown and gloves; face mask or PAPR; goggles; shoe covers; gowning anteroom | 5 | 5 | Continuous particle monitoring; same limits apply in operation | 3,520 | 29 | positive | 3 | 60 | 40 | EU GMP Annex 1 2022 (EudraLex Vol.4) | 22 | 20 | Grade A maintained both at rest and in operation; loss of Grade A conditions triggers investigation |
| EU_GMP_ANNEX_1 | GRADE_B_AT_REST | B | at rest | Full aseptic gown; dedicated cleanroom garments; double gloves; face mask; sterile shoe covers | 5 | 5 | Every 6 months classification; continuous viable monitoring near Grade A | 3,520 | 29 | positive | 5 | 60 | 40 | EU GMP Annex 1 2022 (EudraLex Vol.4); ISO 14644-1:2015 | 22 | 20 | Background environment surrounding Grade A; preparation of aseptic products without filter sterilisation |
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