Medical Device Link.

Originally Published PMPN March 2004

NEWS

Table I. A comparison of the current EP tests, current USP tests, and revised USP tests on rubber closures. Click to enlarge.

USP general chapter 381, “Elastomeric Closures for Injections,” mandates physicochemical tests but contains no specifications. In that respect it differs from the European Pharmacopoeia (EP) and the Japanese Pharmacopoeia. The revised chapter now closely mimics the EP chapter on elastomeric closures, containing essentially the same tests and specifications. Edward J. Smith, PhD, manager, Package Testing, Wyeth Pharmaceuticals (Collegeville, PA) heads the PDA Packaging Science Interest Group. This group was one of several invited by USP to submit suggestions for revising chapter 381.

USP published a draft of the chapter revision in Pharmacopeial Forum (PF 29(1)[Jan–Feb 2003]), then modified it further based on the suggestions it received on the draft. The revised chapter was again published in Pharmacopeial Forum in January 2004 (PF 30(1)[Jan–Feb 2004]). 

The revision to this chapter is now scheduled to appear in USP 28. The effective implementation date is January 1, 2006, pending the receipt of substantial objections or comments that would result in a delay.

“This revision will probably have very little impact because all the component suppliers, and of course, pharmaceutical companies, already sell into Europe where the EP is mandated. Pharmaceutical manufacturers are already performing the European Pharmacopoeia test on closures, even those made in the United States, for product to be sold here and in Europe, so they have most of the data required. Most of the closures made by U.S. manufacturers meet the specifications in the European Pharmacopoeia already. In fact, there is an advantage. Now by doing just one set of tests, a manufacturer will meet most of the USP and the EP requirements,” Smith explains.


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