IS 3692 : 1975 Specification for Rubber Closures, Pharmaceutical

UDC 615.014.87 : 678.4.06 PCD 13
Reaffirmed 2017

1 Scope

1.1 This standard prescribes the requirements and the methods ofsampling and test for rubber closures suitable for steamsterilization and intended for use with vials of injectableproducts in the form of aqueous solution or solids to bereconstituted before use. It is not intended for rubber closures tobe used for oily injections.

2 References

IS 2 :1960Rules for rounding off numerical values

IS 170 :1966Specification for acetone

IS 265 :1962Specification for hydrochloric acid

IS 1984 : Part I :1971 Specification for glass vials forpharmaceutical preparations: Part I Vials forparenteral preparations

IS 2123 :1962Specification for vial (goldie) seals

IS 3400 : Part II :1965 Methods of test for vulcanized rubbers:Part IIHardness