by Dave Burgess and Charlie Miskell
December 17, 2011

For instance, a certification to meet the U.S. Pharacopeia Plastic Class VI Requirement is a frequent request. This requirement is a biological reactivity test whereby samples of the gasket material are tested by implanting them into live animals to confirm that no toxic reactions occur from the material. These tests must be done by approved laboratories recognized by the U.S. Pharmacopeia.

Other countries have also changed many of the regulations specific to direct and indirect contact with foodstuffs and related products. One example is the recent changes in the Official Journal of the European Union Regulation (EC) No 1935/2004 which sets forth the principals for any material or article intended to directly or indirectly contact food. This regulation along with (EC) 2023/2006/EC, which sets forth the principals of good manufacturing practice (GMP) relative to such products, suggests similar practices and concerns as those here in the U.S.

Conclusion

Contact gasket material manufacturers and ask them to provide the required information to qualify a product as suitable for FDA related applications. As noted in this article, such verifications require extensive and complex research and confirmation before a material can be categorized as FDA suitable.

 

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