SOP for Cleaning of Sterile Dress Cabinet
1.0 Purpose
To establish a standard procedure for the routine cleaning and disinfection of the sterile dress cabinet to ensure aseptic conditions are maintained for storage of sterile garments.
2.0 Scope
This SOP applies to all sterile dress cabinets located in controlled and classified areas of the sterile manufacturing facility.
3.0 Responsibility
- Housekeeping/Production Staff: Perform cleaning and disinfection as per this SOP.
- QA Department: Monitor and verify cleaning records, ensure compliance.
- Engineering Department: Support with maintenance, if required.
4.0 Materials and Equipment
- Sterile 70% IPA (Isopropyl Alcohol) solution
- Validated disinfectants (rotational basis, e.g., Quaternary Ammonium Compound, Hydrogen Peroxide)
- Sterile wipes or lint-free sterile cloths
- Sterile gloves
- Cleaning logbook
5.0 Procedure
5.1 Frequency
- Routine Cleaning: At the beginning and end of each working shift.
- Deep Cleaning: Once a week.
- After Spillage/Contamination: Immediately.
5.2 Cleaning Steps
- Disinfect hands/gloves before starting the cleaning process.
- Ensure cabinet is empty before cleaning.
- Wipe external surfaces (doors, handles, control panel) using sterile 70% IPA.
- Clean internal shelves, walls, and floor of cabinet with sterile 70% IPA.
- For deep cleaning (weekly):
- Use validated rotational disinfectants in place of 70% IPA.
- Wipe HEPA grills gently with sterile wipes. Do not touch filter surfaces directly.
- Allow surfaces to remain wet for recommended contact time.
- Ensure cabinet is completely dry before loading garments.
- Dispose used wipes as per bio-waste disposal SOP.
5.3 Precautions
- Do not use abrasive material that may damage surfaces.
- Avoid direct spraying on HEPA filters.
- Ensure cabinet is not overloaded post cleaning.
- Do not touch internal surfaces after cleaning until cabinet is loaded with garments.
6.0 Documentation
- Record cleaning details (date, time, disinfectant used, initials) in the cabinet cleaning logbook.
- QA to review and sign cleaning records periodically.
7.0 References
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products
- ISO 14644 Cleanroom Standards
- Facility Cleaning and Disinfection Validation Protocols
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