Integrity of Sterile Zone (cont'd)

• The sterile zone must be presterilized to a condition of commercial sterility (i.e., nothing can grow)

• Once the sterility of the sterile zone has been established, it must be maintained

• Everything entering the zone must be sterile

• Integrity of the sterile zone is critical

• Clean rooms do NOT meet the definition of commercial sterility

• Steilizing media must be an approved under 21 CFR 178.