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Table 12 from the proposed chapter summarizes these requirements.
As indicated in the table above, CSPs that are sterilized in their final container-closure systems (terminal sterilization) are permitted longer BUDs than CSPs that are sterilized via filtration.
Category 1 CSPs Category 1 CSPs are only allowed a BUD of 12 hours at controlled room temperature or 24 hours if refrigerated.
Category 2 CSPs The proposed guidelines allow a longer BUD for category 2 CSPs, especially those that are terminally sterilized, prepared using only sterile components, tested for sterility, or stored in refrigerated or frozen storage conditions.
Additionally, common aseptic techniques should be followed.
The immediate-use provision in USP allows the preparation and dispensing of CSPs without the need to be in compliance with the requirements as stipulated in USP for low-risk level CSPs (e.g., ISO Class 5 hood or isolator, facility design and environmental controls, and personnel cleansing and garbing).
The current chapter only explicitly calls for an investigation to be conducted in the event of a sterility test failure or the recovery of colony-forming units during environmental monitoring if the facility’s action level is exceeded.
Additionally, the proposed chapter requires that calibrated chart recorders are used to monitor each cycle for sterilization and depyrogenation in autoclaves and dry heat ovens.
The proposed chapter explicitly states that “terminal sterilization (e.g.
dry heat, steam, or irradiation) is the preferred method unless the specific CSP or container-closure system cannot tolerate terminal sterilization.” The proposed chapter places a greater emphasis on the requirement for conducting investigations and implementing corrective actions.
The proposed chapter is open to public comments until November 30, 2018, and is expected to become official on December 1, 2019.
The proposed revision differs from the current chapter in both its structure and content.