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What Cleanroom Classification Should I use for this process?

(A guide)
Grade A (ISO 4.8 for particles ≥ 5.0 microns)

 High-risk operations – filling zones, stopper bowls, open ampoules and vials.
 Laminar air flow required
 Homogenous Air Speed Required – 0.36-0.54 m/s.
 Minimum 1m3 sampling volume

Grade B (ISO 5 for at rest; ISO 7 for in operation)

 Aseptic preparation and filling


 Background environment for grade A operations.
Grade C (ISO 7 for at rest; ISO 8 for in operation)

 For less critical stages


Grade D (ISO 8 for in operation)

 For less critical stages

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