Polyethylene Containers USP

This test is conducted on containers heat-sealed with foil laminate therefore, only the properties of the container are evaluated. The level of protection from water vapor permeation provided by a packaging system marketed with a heat-sealed foil laminate inner seal (up to the time the inner seal is removed) is expected to be approximately the same as that determined by this test. The acceptance criteria are those established in USP 671 . 

This test measures the water vapor permeation of a singleunit or unit-dose container closure system and establishes acceptance criteria for five standards (Class A-E containers). 

This test is intended for drugs being dispensed on prescription, but it has also been applied to the drug product manufacturer s container closure system. If the container closure system has an inner seal, it should be removed before testing. The results from this study reflect the contributions to water vapor permeation through the container and through the seal between the container and the closure. 

Acceptance criteria have been established for two standards (tight containers and well-closed containers). 

For solid oral dosage forms, a reference to the appropriate indirect food additive regulation for each material of construction is typically considered sufficient evidence of safety. However, for a powder for reconstitution dosage form, reference only to the indirect food additive regulations as evidence of safety for the materials of construction is not recommended. Compatibility for solid oral dosage forms and for powders for reconstitution is typically addressed for plastics and glass by meeting the requirements of the Containers test. 

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