A Simple Choice: Selecting a Vial Stopper which Ensures Container Closure Integrity Across a Range of Vial Types

Components for vial containment systems are offered in an array of options; for stoppers they are elastomer type, configuration, size, and surface treatment (coating or laminate). Stopper selection is based on: (a) compatibility with the vial selected and (b) system ability to protect the drug product through shelf life.

Not every combination of vial and stopper can be evaluated before selection. What can be evaluated is the performance of select key combinations that inform performance of combinations generally. Such knowledge enables informed judgment at the outset of component selection. To this purpose, West recently has completed two major studies - both conducted over two years.

Evaluated was effect on container closure integrity (CCI) performance of variation in:

• Stopper size and configuration (serum/lyophilization) for a particular elastomer
• Glass vial size, design (straightwall/European/US), and supplier

Performance was evaluated by two CCI methods endorsed in USP <1207> - tracer gas leak detection (with helium) and laser-based gas headspace analysis (with oxygen).

The recent white paper Vial Containment Systems Based on Elastomer 4031/45 Gray - Performance Independent of Stopper Configuration/Size or Vial Style summarizes these two studies as relates to (bromobutyl) elastomer formulation 4031/45 Gray. It was found that for the selected stoppers evaluated, no CCI performance variation was observed resultant from either size/configuration or vial size/style. Combined with similar CCI performance data from other elastomer formulations (4023/50 Gray and 4432/50 Gray), this suggests strongly that, with proper assembly, any of the following 4031/45 Gray stoppers should perform well independent of vial style.

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