Restrict Cleaning During High-Shedding Operations to Avoid Contamination

Avoid Cleaning Activities During High-Shedding Operations

Remember: Never initiate cleaning during high-shedding operations — wait until such activities are complete to avoid spreading contaminants in GMP zones.

Why This Matters in GMP

Operations like granulation, milling, and powder weighing generate substantial airborne particles that may not be immediately visible but can settle on surfaces, equipment, or open product containers. Cleaning activities during such operations can disrupt airflow patterns, lift settled particles, or inadvertently transfer contaminants across surfaces — increasing the risk of cross-contamination or product failure.

For instance, dry sweeping or wiping surfaces while granules are being discharged from a fluid bed dryer can stir up particles, contaminating nearby equipment or materials. Similarly, vacuuming near a weighing balance during API transfer can redirect airborne dust to adjacent clean areas. Cleaning must be strategically scheduled outside active manufacturing hours or between operations for maximum GMP control.

Also Read: Use Only Validated Autoclaves for Sterile Component Preparation

Regulatory and Compliance Implications

21 CFR Part 211.67 mandates effective cleaning to prevent contamination. EU GMP Chapter 3 requires that facility and equipment cleaning be done in a way that avoids the generation and dispersal of dust. WHO GMP similarly emphasizes proper scheduling of cleaning activities to protect the manufacturing environment.

Inspectors review

cleaning schedules, cross-contamination risk assessments, and production logs. Simultaneous cleaning and product handling may lead to observations related to poor contamination control, improper facility zoning, or lack of procedural discipline — especially if dust monitoring or cleanroom classification is affected.

Implementation Best Practices

Design cleaning SOPs to prohibit activities like sweeping, mopping, or vacuuming during active powder handling or granulation. Schedule cleaning between shifts or after operations are fully completed and materials are securely covered. Use dedicated cleaning tools for each area and minimize movements that could spread powder residues.

Also Read: Check Granulator Belt Tension Before Use to Prevent GMP Equipment Failures

Integrate cleaning activities with the production plan and line clearance protocols. Train housekeeping and production staff on timing controls and use signage to indicate “No Cleaning During Operation” zones. Monitor airborne particle levels to assess the impact of concurrent operations and adjust procedures accordingly.

Regulatory References

– 21 CFR Part 211.67 – Cleaning and maintenance
– EU GMP Chapter 3 – Premises and Equipment
– WHO TRS 961, Annex 3 – Cleaning practices and zoning
– ISPE Good Practice Guide – Contamination Control