Page 90 - Pharmaceutics IV (02-06-01305)

Parenterals: Quality control testing

Container-closure integrity/ Leaker testing

• The packaging system should be closed or sealed in such a manner
as to prevent contamination or loss of contents.

• It’s specifically conducted for glass ampoules.
• It’s a nondestructive test (whole-batch test).

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Parenterals: Quality control testing

Container-closure integrity/ Leaker testing

Methylene blue test:
• Ampoules that have been sealed by fusion must be tested to ensure

that a hermetic seal was obtained.
• It is performed by immersing the ampoules in a dye solution, such as

1% methylene blue, and applying vacuum for a minimum of 15
minutes then releasing vacuum. Next, the ampoules are washed,
where defective ampoules will contain blue solution.

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Salma E. EL-Habashy 87