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Defect Types

In general, all defects on finished parenteral products can be categorized into three major groups:

  • Particulate matter
  • Closure integrity issues
  • Cosmetic defects

Particulate Matter

A particulate matter is defined as a fragment/particle external to the formulation and filling process.

A particulate matter is typically considered as a critical defect due to the impact when injected into the body. Moreover, particulate matter could potentially host harmful microorganisms causing contamination of the product.

Typical materials of a particulate matter are fiber, glass, rubber/plastic and metal.

Closure Integrity Issues

A closure integrity issue is defined as a breach of the sterile environment of the closed primary packaging material.

A closure integrity issue is typically considered as a critical defect due to the potential contamination of the product.

Typically, closure integrity breaches appear on the glass barrel, plunger area and stopper area.

Cosmetic Defects

Cosmetic defects do not typically alter the product quality or the product efficacy. However, some cosmetic defects can potentially develop to a critical defect, e.g. from a deep scratch to a penetrating crack compromising the product sterility.

Common cosmetic defects are scratches, dirt or dust on the glass barrel and scratches or dents on the cap.