Do Not Store Clean and Dirty Garments Together in GMP Facilities

Never Store Clean and Used Garments Together in GMP Areas

Remember: Dirty garments must be segregated from clean ones to prevent cross-contamination and maintain sterile hygiene in cleanroom zones.

Why This Matters in GMP

Gowning practices are critical to preventing microbial and particulate contamination in cleanrooms. Storing used or soiled garments with fresh, sterilized ones poses a significant contamination risk. Bacteria, skin flakes, or residues from used garments can transfer onto clean clothing, compromising their protective function. GMP hygiene protocols require physical segregation between clean and dirty garments, including separate storage racks, laundry bins, and dedicated gowning zones. Violating these rules may lead to product contamination, environmental excursions, and audit findings. Consistent segregation reinforces personnel hygiene and protects cleanroom integrity.

Also Read: Monitor Utility Systems Like Water and Compressed Air for GMP Quality

Regulatory and Compliance Implications

FDA 21 CFR Part 211.28 mandates maintenance of clean clothing and hygienic practices. EU GMP Annex 1 requires separation of clean and used garments with appropriate storage. WHO GMP and Schedule M specify gowning procedures and hygiene controls in sterile environments. During inspections, auditors examine gowning areas for signs of cross-storage, improper labeling, or hygiene breaches. Mixing clean and dirty garments is treated as a serious compliance failure, particularly in sterile manufacturing. Facilities must demonstrate consistent adherence to gown segregation policies supported by SOPs and training records.

Implementation Best Practices

Establish clearly marked zones for clean gown storage and soiled gown collection.
Use different colored bins and gown bags to avoid confusion.
Train personnel on proper gown donning and doffing techniques with visual reminders posted in gowning rooms.
Audit gowning areas frequently to check for compliance with segregation SOPs.
Maintain gown rotation logs to monitor usage, laundry cycles, and damage reports.

Also Read: Never Skip Microbial Monitoring in Critical GMP Zones

Regulatory References

FDA 21 CFR Part 211.28 – Personnel Responsibilities
EU GMP Annex 1 – Cleanroom Garment Practices
WHO GMP – Personal Hygiene in Clean Zones
Schedule M – Gowning and Change Room Controls