Revised Technical Guide for Metals and Alloys

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

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:

• Alignment with the guiding principles of the Council of Europe Resolution on the Safety and Quality of Materials and Articles for contact with Food;
• Amendments to tolerable daily intakes (TDIs) and specific release limits (SRLs);
• Quality requirements and use recommendations;
• A new section on zirconium;
• Improvements related to release testing;
• Improvements related to the expression of uncertainty surrounding measurements.

Further information is provided in:

• EDQM´s Publications on food contact materials and articles (including guidance on substances migrating from printing inks and paper and board),
• Council of Europe's policy statements concerning materials and articles intended to come into contact with foodstuffs (including statements on coatings, rubber, silicones, etc.), 
• EDQM´s Newsroom: Metals and alloys used in food contact materials and articles: updated technical guide.