Easing Polymer Studies

Qualifying new polymers for use in pharmaceutical packaging and in medical devices is a lengthy process, often for both critical and noncritical components. Polymers used for inhalable or injectable drugs are subject to especially rigorous requirements. Material innovations, therefore, emerge slowly, which could discourage change.

Could harmonizing certain methods ease the qualification process for introducing new materials, changing existing ones, or using new suppliers?

At Pharmapack 2010, Michael Spallek, director of Boehringer Ingelheim’s Global Skill Center in Packaging Development, told attendees about such harmonization efforts behind the Polymer Forum. The consortium seeks to “improve and standardize the approach to marketing and supplying polymer materials,” Spallek explained.

Fourteen companies currently make up the consortium, including Boehringer Ingelheim and other manufacturers listed on the site. Membership is open to all pharmaceutical manufacturing companies at the discretion of the current members.

While membership is not available to polymer suppliers or molders, the group seeks closer cooperation between pharmaceutical companies and polymer manufacturers. Its goal is to provide guidance to polymer companies on pharmaceutical industry requirements, defining minimum needs and encouraging an open, noncommercial discussion.

For instance, “generic methods for monitoring extractables from plastics for pharmaceuticals and medical devices could be developed,” Spallek explained. Sterilization and barrier performance could also be documented. The consortium’s long-term vision is to harmonize methods.

The group meets biannually and offers polymer makers the chance to present products and strategies to members.

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