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Revision der Anforderungen des Europäischen Arzneibuchs an Glas als Primärpackmittel und ihr Bezug zu internationalen Normen

Dr. Anne Deicke, Michael Zlottchenko und Dr. Jochen Norwig

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn

Revision of the European Pharmacopoeia Requirements to Glass as Primary Packaging Material and Their Relations with International Standards

For a long period the monograph on „Glass containers for pharmaceutical use“ of the European Pharmacopoeia has been unchanged. In 1997 and in 2002 two drafts for revision were published in Pharmeuropa. The following was taken into consideration: First, in few cases glass as a p rimary packing material shows incompatibilities, e.g. with special kinds of parenteral preparations and second, the monograph should be adapted to ISO-Standards on the determination of hydrolytic resistance. According to the comments on the drafts the new statements on the compatibility of the glass container seemed to be accepted whereas objections on the proposed way of adaption to ISO-Standards have been raised.

Key words Europäisches Arzneibuch · Glasbehältnisse, Qualitätsanforderungen, regulatorische Anforderungen · ISO-Standards · Primärverpackungsmaterial