Never Use Damaged Sieves or Mesh During Granulation in GMP

Damaged Sieves Must Not Be Used in Granulation Processes

Remember: Inspect all sieves and meshes before use—damaged screens compromise granule size, uniformity, and product safety.

Why This Matters in GMP

Sieves are used during granulation to control particle size distribution and ensure blend uniformity. A torn or distorted sieve can result in oversized or undersized particles, affecting tablet hardness, dissolution, and bioavailability. Worse, metal fragments or loose wires may detach and contaminate the batch, posing serious safety hazards. Continued use of damaged sieves reflects poor equipment management and lack of preventive maintenance. GMP manufacturing requires that only qualified, intact equipment be used at every stage of processing. Regular inspections of mesh screens are essential to product quality, equipment longevity, and patient safety.

Also Read: How to Prevent Counterfeit Pharmaceuticals in the Supply Chain Using GMP

Regulatory and Compliance Implications

FDA 21 CFR Part 211.65 and 211.67 require proper construction, maintenance, and cleaning of equipment. WHO GMP and Schedule M stress inspection and control of manufacturing tools and their impact on product quality. EU GMP Chapter 5 and 3 also require equipment to be suitable for intended use and maintained in good condition. Regulatory auditors frequently inspect equipment logs and check for visual signs of screen damage. Use of damaged sieves can trigger recalls, product rejection, and compliance observations for poor maintenance practices.

Implementation Best Practices

Inspect sieves before and after use under adequate lighting conditions.
Maintain a sieve integrity checklist and record verification before batch startup.
Assign unique ID numbers to sieves and link them to usage logs and cleaning records.
Train operators to recognize mesh damage and quarantine any compromised tools immediately.
Include sieve inspections in equipment qualification and periodic maintenance SOPs.

Also Read: Never Discard Rejected Materials in General Trash Bins

Regulatory References

FDA 21 CFR Part 211.65 – Equipment Construction
FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
WHO GMP – Equipment Requirements
Schedule M – Equipment Inspection and Maintenance
EU GMP Chapter 5 – Production