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Process Control & Quality Assurance
Our capsule manufacturing infrastructure integrates over 10 precision-engineered unit operations, managed under strict GMP-compliant process controls, and validated by a 100% pre-shipment inspection protocol.
- 1. Material Dispensing & Batching:
Gelatin and active excipients are weighed with high precision according to the master formula to ensure compositional accuracy.
- 2. Gel Solution Preparation:
Thermal melting of raw materials is executed under validated temperature-time profiles to yield a homogeneous gelatin mass.
- 3. Dipping, Drying & Demolding:
Capsule shells are formed via pin dipping, sequentially dried, and demolded under strictly regulated psychrometric conditions.
- 4. Trimming, Sorting & Joining:
Pods are trimmed to specification length; defective units are automatically rejected prior to the precise mechanical joining of caps and bodies.
- 5. Imprinting Process:
Regulatory identifiers and product markings are printed onto the capsule surface utilizing validated machine parameters.
- 6. Post-Printing Inspection:
A dedicated secondary inspection phase isolates and removes any surface finish or typographical anomalies.
- 7. Primary Packaging & Terminal Sterilization:
Packaging operations are conducted in a Grade-D cleanroom environment, followed by sterilization to mitigate risks of secondary microbiological contamination.
- 8. Finished Product Release Testing:
Full compendial analysis is performed prior to batch release, including critical quality attributes (CQAs) such as aesthetics, lock tightness, brittleness, and microbial limits.
- 9. Finished Goods Warehousing:
Compliant batches are transferred to controlled-environment storage to conclude the manufacturing lifecycle.
Contact for capsule details:
Emily Song
Cell&Whatsapp: 0086-182 6755 3691
Email: emily@yuexicapsules.com
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