Use Cleanroom-Grade Wipes for Cleaning in Sterile GMP Areas

Always Use Cleanroom-Grade Wipes in Sterile Areas

Remember: Only use sterile, validated cleanroom wipes for surface cleaning in classified GMP environments.

Why This Matters in GMP

Sterile manufacturing environments demand strict control over microbial and particulate contamination. Using non-validated wipes can introduce fibers, particles, or microbial load into clean zones. This defeats the purpose of environmental control and increases the risk of product contamination. Cleanroom-grade wipes are designed to minimize residue, are lint-free, and are often pre-saturated with disinfectants. These are validated for use in sterile zones and come with traceable lot numbers and certificates. Improper cleaning material not only jeopardizes sterility assurance but also reflects poorly on operator training and SOP adherence. Consistent use of cleanroom wipes supports a contamination-free workspace and aligns with GMP best practices.

Also Read: Conduct Risk Assessments Before Implementing Process Changes

Regulatory and Compliance Implications

EU GMP Annex 1 and FDA 21 CFR Part 211.67 require validated cleaning practices and materials for sterile areas. WHO GMP outlines specifications for cleaning agents and wiping materials in aseptic zones. Schedule M mandates that cleaning be done using approved procedures and materials that prevent contamination. Inspectors routinely verify cleaning logs, material usage records, and purchase orders for sterile supplies. Use of unapproved cleaning materials in sterile areas can result in major regulatory citations, especially in sterile product facilities. Cleaning practices must be traceable, repeatable, and documented in accordance with validated protocols.

Implementation Best Practices

Procure cleanroom wipes from qualified vendors with CoA and sterility data.
Maintain inventory logs for wipe batches used in sterile zones.
Train staff on proper wiping techniques, frequency, and rotation of disinfectants.
Incorporate cleaning wipe usage in environmental monitoring trends and deviation tracking.
Document usage in line clearance and room cleaning records.

Also Read: Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

Regulatory References

FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
WHO GMP – Sanitation and Hygiene Requirements
Schedule M – Sterile Product Manufacturing Guidelines