What are the manufacturing defect of the capsule?

What are the manufacturing defect of the capsule?


Bubbles Improper vacuum or duration of the gelatin bubbles extraction process.
Damaged print Improper ink viscosity and applying pressure, uneven flow of the ink, clogged ink jets, incomplete drying of ink etc.

What are the defects of hard gelatin capsule shells?

Common Defects in Hard Gelatin Capsules

  • Shell surfaces not smooth.
  • Opacify not proper.
  • Empty capsules after the filling stage.
  • The foreign matter inside the capsules.
  • Capsules fitting not uniform during filling.
  • Capsules are not of the specified type.
  • Color variation and non-uniformity of appearance.

What are quality control test involved in manufacturing of hard gelatin capsules?

Visual inspection, fill weight, and fill-weight uniformity are the key in-process tests used for hard gelatin capsules.

How temperature affects the integrity of capsule shells?

Temperature is a key parameter that should be strictly controlled during disintegration and dissolution testing of capsules. Problem arises when temperature falls below 37 °C, since gelatin solubility decreases. At temperature below 30 °C, the capsule shells are insoluble and simply absorb water, swell and distort.

What are the various types of capsule defects?

How to Troubleshoot the 7 Most Common Capsule Defects

  • Lumpy or misshapen capsules. If the capsules form lumps or are otherwise.
  • Improper rectification.
  • Failure to separate.
  • Dented capsules.
  • Telescoping.
  • Popping.
  • Brittleness.

What are the types of gelatin used for the manufacture of capsules?

The primary gelatin types used in capsules are typically from bovine or porcine raw materials. Depending on the fill, formulation and on the target market group, manufacturers have flexibility in the raw material type, with some opting for a combination of porcine and bovine options.

Is capsule shell harmful?

Capsules can be hard-shelled or soft-shelled. However, capsules made from gelatin carry some side effects too. They are reported to cause indigestion, upset and bloated stomach, hypersensitivity, exposure to toxins leading to gastric problems, and their excessive consumption can also cause kidney and liver damage.

What is significance of quality control testing for capsule?

The test which are performed during the manufacturing of product which include thickness, hardness, friability, dissolution time, disintegration time. Inprocess quality control test is necessary to insure the safety of finished pharmaceutical product.

What is the general tests for in process quality control?

In-process materials should be tested for identity, strength, quality and purity as appropriate and approved or rejected by the quality control unit during the production process. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing .

How does humidity and temperature affects the characteristic of hard gelatin capsule?

As the humidity of the environment increased up to 50%, the storage modulus of the capsule starts to decrease at temperature higher than 40°C. At 60% humidity, the storage modulus of the capsule at 20°C is only 50% compared with its dried condition. And it keeps dropping as temperature increases.

What is the recommended storage condition for empty hard gelatin capsules?

Hard gelatin capsules shall be stored between 15-25oC (68-75oF) and 45-55% relative humidity to maintain the 12-16% moisture content of capsules. It is important that this moisture content is maintained and exposure to high temperatures or cycling between high/low temperatures is avoided.