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Parenterals: Quality control testing

Foreign and particulate matter/ clarity testing

Visible particulates
• Each final container of all parenteral preparations should be manually

inspected for the presence of observable foreign and particulate
matter in its contents.
• It’s a nondestructive test (whole-batch test).
• This 100% inspection of a lot of product is designed to prevent the
distribution and use of parenterals that contain particulate matter.

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Parenterals: Quality control testing

Foreign and particulate matter/ clarity testing

Visible particulates
• Usually, an inspector passes the filled container past a light source

with a black background (for light colored particles) and a white
background (for dark colored particles) to observe mobile particles.
• Every container in which the contents show evidence of visible
particulates must be rejected.
• This may take place during examination for other defects such as
cracked or defective containers or seals.

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Salma E. EL-Habashy 84