[Proposal of JP standards for plastic containers for pharmaceuticals].

Abstract

A new approach to standardization of plastic containers for pharmaceuticals in the Pharmacopoeia of Japan (JP) has been proposed, structured into the following three parts: (1) "Plastic Containers for Pharmaceuticals" in the GENERAL INFORMATION section that describes the general requirements and rationales for conformity; (2) "Test Methods for Plastic Containers" in the GENERAL TESTS section that describes various test methods applicable for verifying conformity; (3) Special requirements and/or limit values for special containers such as infusion bags in a MONOGRAPH section. New standards should be designed to cover plastic containers of any shape and volume made of any kind of material.