Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. In 2016 the USP Expert Committee "General Chapters-Packaging and Storage" announced to develop a new General Chapter <662> "Metal Packaging Components and their Materials of Construction". Common metal packaging components include aluminum and its alloys, stainless steel, tin-free steel, and tin. Additionally a stimuli article (Metal Packaging Systems and Their Materials of Construction for Pharmaceutical Products) was published in PF 39(4) (July-August 2013). However, the proposed USP chapter has still not yet been released. Thus any other guidance providing information on metal components, e.g. from the food area, can be useful.

EDQM´s practical guide for manufacturers and regulators

The 1st edition of EDQM´s technical guide “Metals and alloys used in food contact materials and articles” has been completely reviewed by the European Committee for Food Contact Materials and Articles to take into account regulatory developments and recent risk assessments. The 2nd edition was open for public consultation until 29 April 2022.

According to the announcement updates to the 2nd edition include the following:

Further information is provided in:

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