Never Clean GMP Visors Using Fabric Towels That Shed Fibers

Don’t Clean Visors in GMP Areas Using Fiber-Shedding Towels

Remember: Use only validated, lint-free wipes for cleaning visors in GMP zones — fabric towels can introduce fibers and compromise cleanroom conditions.

Why This Matters in GMP

Visors and face shields used in GMP environments — especially sterile areas — are part of the gowning ensemble that prevents contamination from operators to the product. Cleaning these visors using regular fabric towels can result in shedding of lint, cotton fibers, or threads. These particles may settle on product contact surfaces, equipment, or within the cleanroom air, leading to particulate excursions or microbiological growth in critical zones.

Also Read: Pharmaceutical and Medical Devices Agency (PMDA)

For example, wiping a face visor with a standard cloth in a Grade B gowning area may release particles that contribute to elevated airborne counts or surface contamination in subsequent monitoring cycles.

Regulatory and Compliance Implications

21 CFR Part 211.28 requires personnel to maintain cleanliness and hygiene during drug manufacturing. EU GMP Annex 1 mandates non-shedding, validated cleaning materials for cleanrooms and protective garments. WHO GMP specifies the need for proper gown maintenance and cleanliness to prevent contamination.

Auditors check visor cleaning logs, materials used for gowning item care, and environmental monitoring

trends. Observations can arise if unvalidated or particle-generating materials are used in critical or aseptic zones.

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

Implementation Best Practices

Use sterile, non-linting wipes approved for cleanroom use. Include specific instructions in gowning SOPs for visor cleaning, specifying wipe types, cleaning technique, and frequency. Visors should be inspected for scratches or wear that may harbor contaminants.

Train all operators and cleanroom personnel on the risks of using fabric towels and the correct method of visor maintenance. Monitor and document cleaning activities in gowning room logs or during shift inspections.

Regulatory References

– 21 CFR Part 211.28 – Personnel hygiene and garment care
– EU GMP Annex 1 – Cleanroom gowning practices
– WHO TRS 961, Annex 6 – Gown and accessory maintenance
– ISO 14644-5 – Cleanroom clothing and contamination control

Also Read: Label In-Process Samples with Date and Initials for Traceability