Defects in hard gelatin capsules

different types of defects in capsule and remedies

Hi Vinod,
Question is simple but answer seems quite tough. Just to make it simpler and easy to understand for you and all the active members of PG I would like to classify these defects into manufacturing and products stages. During manufacturing of Hard Gelatin Capsules which involves several steps like: dipping of stainless steel die to gelatin mass, rotation, drying, stripping, trimming and joining of cap and body of capsules. during several operations few defects are formed at this stage only like: (Consider “M” for Major defect and “m” for minor)

  1. Capsule are not of specified type i.e. hard shell formation (M)
  2. It may have cracks, breaks, pinholes or splits, loosing its integrity (M)
  3. Color variation, and non uniformity of appearance (M)
  4. surface spots and embedded particles on capsules (M)
  5. body and cap are not uniform and does not fit properly (M)
  6. it may have different odor than specified (M)
  7. there are pits, dents, thin area, specks, spots or blemishes (m)
  8. capsules surfaces are not smooth (m)
  9. Capsules not free of adhering surface spots (m)
  10. Opacity not proper (m)
    and some defects in production stage:
  11. Empty capsule (M)
  12. Some foreign matter inside the capsules (M)
  13. Fitting of capsules are not uniform during filling activity (M)
  14. Immediate container not internally or externally cleaned (M)

However these are few examples to set a inspection plan but it should not be restricted to classify more defects when observed and identified. this defects are applied for examination of capsules in filled, final (immediate) containers.

For more details on capsule defects (hard gelatin) you may refer to Americal federal Standard No. 285A (1976).

Hope I answered your query.

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