Closures on a container-closure system are a critical part of the packaging for a sterile product. These closures maintain the sterility of the pharmaceuticals and prevent any contamination.
What Are Container-Closure Systems?
Parenteral products are formulated and packaged to both be sterile and maintain their sterility during terminal sterilization processes. A crucial part of package design lies in their container-closure mechanism, which functions to keep the contents sterile and prevent any contamination after a needle is inserted. An example of this is enabling resealing of the vial once the needle is withdrawn. Manufacturers of these products must have confidence in their quality control, as well as in their validation processes.
Closures, also known as stoppers or bungs, are an important piece of the final packaging of a pharmaceutical. The most common type of stopper is known as an elastomeric closure. Elastomers are any materials that can maintain the same shape when a deforming force is removed (known as their viscoelasticity). Typically, the elastomer in these types of pharmaceutical closures is a synthetic rubber - a material strongly resistant to permeation by oxygen or water vapor.
Compliance with FDA regulations is critical for these types of stoppers. A variety of key points arise when determining the viability of the elastomer. Validation includes ensuring the product cannot be absorbed by rubber, that the rubber cannot leach with the product, and that the seal is effective both alone and when stored along with the product. The ideal container-closure will have low permeability to air and moisture and a high resistance to aging
The container-closure system is an essential part of the final presentation of a pharmaceutical product. It defines the closure, protection, and functionality of a container while ensuring the safety and quality of the drug product over the product shelf life.
MediZap has created a Ready-to-Use vial and closure solution that offers the greatest protection against leachables and extractables.