Two types of Tyvek and high density polyethylene or polypropylene packaging used for
sterilization of rubber closures were evaluated for Microbial Barrier properties. The …

Contamination of sterile products has caused significant adverse outcomes in patients,
including death. Limited research has been conducted on the efficacy and/or superiority of …

Helium leak rate measurements were quantitatively correlated to the probability of microbial
ingress for rubber-stoppered glass vials subjected to immersion challenge. Standard 10-mL …

The effect of sterilization on the number of particles released from five different types of
rubber stoppers, as well as on their surface roughness and elemental composition before …

It was recently found that after storage of a live viral vaccine at− 80° C in glass vials closed
with rubber stoppers, a phenomenon was revealed which had not been observed before …

Sometimes, drug product for parenteral administration is stored in a frozen state (eg,–20° C
or–80° C), particularly during early stages of development of some biotech molecules in …

Rubber closures form a critical barrier in the protection of freeze-dried products against the
uptake of moisture. In this study, the moisture absorption of different rubber lyophilisation …

Sterilization Validation of disposable syringe components presents unique process
requirements due to component design and required mechanical attributes. These include …

The purpose of the present study is to apply and contrast several analytical techniques to
understand the change in moisture content of 20 mm diameter bromobutyl rubber stoppers …

This presentation describes technical subtleties and complexities associated with validating
the sterilization of closure systems. Also presented are areas of misunderstanding and …