A vial-capping process for lyophilization stopper configurations was previously quantified
using residual seal force (RSF). A correlation between RSF and container closure integrity …

Capping completes the closure of parenteral drug products in the final packaging container
and is critical in maintaining an integral seal to ensure product quality. Residual seal force …

The vial capping process is a critical unit operation during drug product manufacturing, as it
could possibly generate cosmetic defects or even affect container closure integrity. Yet there …

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 …

Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems
(CCSs) for injectable drug products when facilitated or self-administration is required …

Frozen-state storage and cold-chain transport are key operations in the development and
commercialization of biopharmaceuticals. Today, several marketed drug products are stored …

Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …

There is a concern that low atmospheric pressure typically encountered during shipment
could result in plunger-stopper displacement in prefilled syringes impacting sterility and …

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 …

Vial breakage during lyophilization reduces yield and can lead to product contamination
with glass particulates, personnel interventions during manufacturing and damage to …