Regulatory requirements for Pharmaceutical Rubber Stopper Manufacturer?

Hi Team,

Please brief about the requirements for the manufacturing plant of Elastometric Pharmaceutical Rubber Stoppers.


pls refer

European Pharmacopoeia, Section 3.2.9 Rubber
Closures for Containers for Aqueous Parenteral
Preparations for Powders and For Freeze-Dried
• United States Pharmacopeia, Section <381>,
Elastomeric Closures For Injections
• Japanese Pharmacopoeia XV, Section 7.03 Test
for Rubber Closures for Aqueous Infusions