SOP for Sterile Dress Cabinet
1.0 Purpose
To define the procedure for the proper operation, cleaning, and maintenance of the Sterile Dress Cabinet used for storing sterilized garments required for aseptic processing areas.
2.0 Scope
This SOP applies to all sterile dress cabinets located in the change rooms and controlled areas of the sterile manufacturing facility.
3.0 Responsibility
- Production/QC Personnel: Follow the SOP for gown retrieval and storage.
- Housekeeping Staff: Clean and disinfect the cabinet as per schedule.
- Engineering Department: Maintain and service the cabinet to ensure proper functioning.
- QA Department: Verify compliance and review records.
4.0 Definitions
- Sterile Dress Cabinet: A controlled cabinet with HEPA filtration or UV sterilization, designed to store sterile garments under aseptic conditions.
5.0 Materials and Equipment
- Sterile dress cabinet
- 70% IPA or validated disinfectant
- Sterile wipes
- Sterile garments (coveralls, masks, hoods, gloves, shoe covers, etc.)
6.0 Procedure
6.1 Pre-Operation
- Ensure the cabinet is clean, disinfected, and switched on.
- Verify that HEPA filter/blower or UV system (if applicable) is functioning.
- Record the operation start time in the logbook.
6.2 Loading of Garments
- Transfer sterilized garments from autoclave in sterile bags to the cabinet.
- Disinfect the outer surface of bags with 70% IPA before placing them inside.
- Avoid overloading; maintain sufficient airflow circulation.
- Arrange garments by type (coverall, hood, mask, gloves, shoe covers) in separate shelves/sections.
6.3 Retrieval of Garments
- Disinfect hands/gloves with 70% IPA before accessing the cabinet.
- Open the cabinet carefully and retrieve only the required garment.
- Avoid prolonged opening of doors to minimize contamination risk.
- Close the cabinet securely after retrieval.
6.4 Cleaning and Disinfection
- Wipe down internal and external surfaces with sterile 70% IPA at the beginning and end of each shift.
- Perform weekly deep cleaning using validated disinfectants.
- Clean HEPA filter grills with sterile wipes; do not touch the filter surface directly.
- Replace pre-filters/HEPA filters as per schedule or based on differential pressure monitoring.
6.5 Maintenance
- Ensure routine calibration and servicing of cabinet blower and UV system.
- Record all maintenance activities in the logbook.
- Report any malfunction immediately to engineering and QA.
7.0 Precautions
- Do not store non-sterile items inside the cabinet.
- Avoid overloading or blocking airflow grills.
- Never touch sterile garments with bare hands.
- Ensure garments are used within validated sterility hold time.
8.0 Documentation
- Maintain logbook entries for garment loading, retrieval, cleaning, and maintenance.
- Record HEPA filter change, UV lamp replacement, and calibration details.
9.0 References
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products
- ISO 14644 Cleanroom Standards
- Internal Facility Validation Protocols
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