Never Use Fiber-Shedding Materials for Machine Cleaning in GMP Areas

Avoid Fiber-Shedding Materials for GMP Equipment Cleaning

Remember: GMP cleaning must use non-shedding, low-lint materials—fiber-releasing cloths can lead to product contamination and audit failures.

Why This Matters in GMP

Cleaning is a key contamination control strategy in pharmaceutical manufacturing. However, using inappropriate materials—like cotton rags, general-purpose mops, or fabric towels—can introduce more risk than it removes. Such materials shed fibers and particulates that can contaminate equipment surfaces, settle in open product zones, or interfere with filters and sensors. In sterile or classified environments, even microscopic fibers can carry microbes or cause product quality issues. GMP mandates the use of validated, non-shedding wipes and tools to maintain hygiene without introducing contaminants.

Also Read: The Role of Technology in Enabling Continuous Improvement in GMP

Regulatory and Compliance Implications

FDA 21 CFR Part 211.67 requires that equipment be cleaned and maintained using methods that do not contaminate the product. EU GMP Annex 1 specifies that materials used in cleanrooms must be non-shedding and appropriate to their intended use. WHO GMP recommends the use of lint-free, low-particle-generation materials for aseptic and sterile areas. Schedule M also prohibits the use of cloths and rags that can shed fibers or particles during equipment cleaning and sanitization procedures.

Regulatory agencies routinely observe cleaning practices during facility walkthroughs. Detection of fiber-shedding materials, such as general cotton wipes or aged cleaning tools, often leads to observations. Particulate contamination from such materials can also show up in filter integrity failures, environmental monitoring results, or finished product quality defects. Cleaning materials should be selected, validated, and documented just like any other critical input in GMP operations.

Also Read: The Importance of Employee Training in Preventing Cross-Contamination

Implementation Best Practices

Use sterile, cleanroom-grade wipes made from polyester or polypropylene with low particle generation.
Store cleaning materials in controlled environments with packaging intact until use.
Train cleaning personnel to inspect tools and wipes before use for integrity and packaging condition.
Include cleaning material specifications and validation data in the cleaning SOPs.
Review environmental monitoring for fiber-like particles as a potential indicator of improper material use.

Regulatory References

FDA 21 CFR Part 211.67 – Cleaning and Maintenance of Equipment
EU GMP Annex 1 – Cleaning Tools and Material Selection
WHO GMP – Contamination Control During Cleaning
Schedule M – Cleaning Procedures and Material Requirements

Also Read: Document Operator Training for Each Product Line to Ensure GMP Compliance