Closures that form part of the container-closure system are an important component in the packaging of sterile products. Container-closures maintain the sterility of parenteral pharmaceuticals and prevent ingress of contamination when a needle is inserted
Parenteral products are designed, formulated, and packaged to be sterile and to maintain sterility. One of the most important parts of the packaging of sterile drug products is the container-closure mechanism. This article examines the use of closures, fo
Pharmaceutical closures, also known as stoppers or bungs, are an important part of the final packaging of pharmaceutical preparations, particularly those that are intended to be sterile. The most commonly used type of stopper is the elastomeric closure. A
Pharmaceutical rubber closures, also known as stoppers, are an important part of the final packaging of pharmaceutical preparations, particularly those that are intended to be sterile. Rubber Closures tightly packs the container to exclude oxygen , carbon
Applications
• Closures maintain the sterility of parenteral pharmaceuticals and prevent ingress of contamination when a needle is inserted into a vial.
• Keep the product secure from undesired premature opening
• Provide a means of reclosing or
QUALITY CONTROL OF CLOSURES
A number of quality control checks are required for the manufacture and release of closures. These checks include:
After the material has been mixed
Specific gravity, which is the ratio of the weight of the molded piece to th
Post-compression and molding
The material is checked for rubber thickness and evenness.
Washing process
During the loading of stoppers into a washer, the quality of the water should be checked for bioburden and endotoxin using compendial methods.
The l