SUPPLIES & EQUIPMENT

Q: What garments do my cleanroom personnel need to wear?

Gowning requirements depend on your ISO classification and applicable GMP guidelines. ISO Class 8 environments typically require dedicated cleanroom clothing, hair covering, and shoe covers. ISO Class 7 requires full coveralls, hoods, gloves, and masks. ISO Class 5 and cleaner environments require full sterile gowning — including sterile coveralls, hoods, gloves, boots, and visors. Your gowning SOP should define specific requirements for each zone of your facility.

Q: How often should HEPA filters be replaced?

HEPA filter replacement frequency depends on your facility's air quality, operating hours, and the results of regular filter integrity testing. In a well-operated pharmaceutical cleanroom, HEPA filters typically require replacement every 3 to 5 years — but integrity testing should be performed at least annually and after any HVAC maintenance that could affect filter integrity.

Q: Can I use any cleaning product in my cleanroom?

No. Cleaning agents used in GMP cleanrooms must be appropriate for your ISO classification, compatible with your surface materials, and validated for use in your facility. Rotating between sporicidal, bactericidal, and fungicidal agents is required in pharmaceutical environments to prevent microbial resistance. Consumer cleaning products are not appropriate for use in regulated cleanrooms.