Quality Control of HPMC Capsule Shells

hard gelatin capsules hard gelatin capsules

Acceptable Quality Level

(Sample size 1250 nos. capsules)

Capsule Defect Category Acceptable Quality Level (AQL %)
Critical 0.01
Major 0.40
Minor 1.0

Classification of capsule defects

(Sample size 1250 nos. capsules)

Capsules are manufactured under controlled condition to ensure conformance to specifications.

Critical defect A defect that affects the performance of a capsule
For the final product
For capsule filling
Major defect A defect that may not affect the machine performance critically.
Minor defect A defect that has no effect on the performance of a capsule as a package. It is a slight blemish that makes the capsule visually imperfect.