Cleaning and Sterilization of Aseptic Manufacturing Equipment
Introduction
This document provides guidance in the cleaning and sterilization of aseptic manufacturing equipment to minimize the risk of particulate and microbiological contamination.
1. Washing Bays for Initial Cleaning and Final Rinsing of Equipment should include, and not be limited to, the following design considerations:
- Floors sloped to a drain;
- A minimum two (2) inch (5cm) air break to drains;
- Water contained and drained within the washing bay;
- Ventilated area to minimize condensation on ceilings and walls; and
- Utilities identified (e.g., water, filtered compressed air).
2. Equipment Washing Machines or Cabinets used to clean small pieces of equipment (e.g., beakers, clamps) should include, and not be limited to, the following design considerations:
- Stainless steel construction, designed to drain and not retain water;
- Effluent water sample port;
- Stainless steel trays and/or baskets designed to be self-draining; and
- Mechanism to remove excess moisture after washing.
3. Equipment should be cleaned promptly after use. The maximum time interval for leaving equipment in the soiled state should be specified and should not exceed fourteen (14) calendar days.
4. Equipment that will not be used or sterilized immediately should be protected from particulate and microbiological contamination and stored in a designated area with the applicable air classification. Protective measures include, but are not limited to:
- Store small items in metal cabinets or on metal shelves; and
- Cover large items (e.g., portable tanks) with non-shedding wraps.
5. If Not Used or Sterilized Within the Maximum Validated Time Interval between cleaning and sterilization or sterilization and use, equipment should be re-cleaned and re-sterilized.
6. Equipment should be protected from damage and should be washed in a manner that precludes generation of particles.
7. Personnel Performing Equipment Cleaning, Preparing Equipment for Sterilization, and Sterilization of Equipment should be qualified. Training in the various tasks should include such topics as:
- Cleaning SOPs, including disassembly and assembly of the equipment;
- Contamination control basics;
- PAA gowning practices;
- Preparation for sterilization including wrapping SOPs;
- Sterilizer load configuration; and
- Operation of the sterilizer.
8. Selection Criteria for Wrapping Materials Used to Protect Equipment that will be steam sterilized should include, and not be limited to, the following:
- Non-shedding material that allows adequate air removal, steam penetration, and complete drying of the wrapped equipment following sterilization;
- Barrier to protect the equipment from microorganisms and particulates after sterilization and before use; and
- Resistant to tearing and puncture. 9. Documentation of Equipment Sterilization should include, but not be limited to:
- Date and time of sterilization;
- Identification of person performing sterilization activities; and
- Sterilization batch cycle or batch number.
9. Wrapped or Packaged Sterilized Equipment should be visually inspected for dryness and package integrity prior to being placed in an APA processing room or the APA equipment storage area. Any torn, compressed, wet, or punctured package should be labelled as damaged and removed from the APA.
10. Preventive Maintenance (PM) of CIP/SIP Systems should include, and not be limited to, the following:
- Calibration of Instruments and Elements (I/Es);
- Verification of cycle parameters (e.g., length of each cycle, amount of CIP chemicals used during the various cycles, pH);
- Inspection of the CIP/SIP system for rusting, pitting, or corrosion; and Passivation, as required.