Abstract
The Instron method of residual seal force measurement is used to study the effects of various closure, time, and processing variables on the residual seal force of parenteral vials. Control vials machined from aluminum with flat, 20-mm serum finishes are used to eliminate inaccuracies inherently caused by glass vial finish variations. The Instron residual seal force is demonstrated to be dependent on closure variables of elastomer formulation, formulation batch, and certain types of inert polymeric coatings. Using halobutyl closures, the seal force is shown to decay with time post sealing and as a result of "terminal" autoclaving
- Received November 25, 1987.
- Accepted February 16, 1988.
- Copyright © Parenteral Drug Association. All rights reserved.
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