FIELD: polymer packaging.
SUBSTANCE: invention relates to polymer packaging, such as a vial or bottle, which is intended for storing a sterile pharmaceutical composition. A package for storing a sterile pharmaceutical composition contains at least an inner layer of polypropylene having a thickness of 200 to 800 mcm and an outer layer made of polyethylene, the outer layer being in contact with the environment and having a thickness of 300 to 1000 mcm. The invention also relates to a method for sterile storage of a pharmaceutical composition using such packaging.
EFFECT: invention provides a new durable packaging for preserving or storing a sterile pharmaceutical composition with a special polymeric outer layer that allows the packaging to withstand the sterilization conditions recommended by the European Medicines Agency (EMA) guidelines while maintaining its strength.
17 cl, 3 tbl, 3 ex
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Authors
Dates
2024-02-06—Published
2020-06-25—Filed