Perform Routine Gown Integrity Checks in Clean Environments
Remember: Cleanroom garments must be regularly checked for damage or wear to prevent microbial or particulate contamination.
Why This Matters in GMP
Gowning is the first line of defense against contamination in controlled manufacturing environments. Over time, cleanroom gowns—whether reusable or single-use—may suffer wear and tear that diminishes their barrier efficiency. Tears, loose seams, degraded elastics, or excessive laundering can compromise gown performance, allowing particulates or microbes to breach the barrier. Routine checks ensure that personnel protection garments maintain their integrity, especially in Grade A/B areas where sterile conditions are critical. Failing to inspect gowns can lead to undetected breaches in hygiene control, increasing the risk of product contamination, failed environmental monitoring, and compromised batch quality.
Regulatory and Compliance Implications
EU GMP Annex 1 and WHO GMP emphasize appropriate gown integrity and maintenance for aseptic operations. FDA 21 CFR Part 211.28 requires cleanliness and protective attire to prevent product contamination. Schedule M mandates the use of intact and hygienic protective clothing in sterile areas. Auditors expect documentation of gown checks, defect logs, and replacement procedures. Observations related to improper gown maintenance are treated as potential contamination risks. Regular integrity checks demonstrate a proactive quality system focused on preventing microbial excursions and upholding cleanroom control measures.
Implementation Best Practices
- Inspect gowns for damage before each use—look for tears, weak seams, or worn patches.
- Use visual inspection checklists and document each gown’s condition at issuance and return.
- Establish maximum reuse cycles for reusable garments based on validated cleaning performance.
- Train personnel to report and segregate damaged gowns immediately.
- Incorporate gown inspection into periodic cleanroom audits and line clearances.
Regulatory References
- FDA 21 CFR Part 211.28 – Personnel Responsibilities
- EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
- WHO GMP – Personal Hygiene and Protective Apparel
- Schedule M – Gowning Requirements in Sterile Areas