Diego Zurbriggen

Supervisor, Lab Leachables

March 31, 2017

Preparing for the Future - Compliance with New USP Chapter <381>

It is essential for companies in the pharmaceutical industry to be prepared to comply with compendial changes as soon as they are enacted. USP Chapter <381> (Elastomeric Closure for Injections), which covers West elastomeric components, is scheduled to be reissued on January 1, 2018 as Components Used in Injectable Pharmaceutical Packaging/Delivery Systems

Scientist in Lab 


The new <381> is entirely self-contained, not employing reference to other USP Chapters for specifications regarding elemental impurities. It specifies analyses for antimony (Sb), arsenic (As), cadmium (Cd), cobalt (Co), copper (Cu), lead (Pb), lithium (Li), mercury (Hg), nickel (Ni), vanadium (V), and zinc (Zn) – with quantitative reporting of actual values measured, based upon a method with detection sensitivity to 0.05 µg per gram elastomer. Anticipating these changes, West began in 2015 to develop methods to comply.
The first objective was development of methods to extract said elements from elastomeric components. The second, very challenging objective, was development of an analytical method with a sensitivity limit to such low values. After substantial research, a method was developed – employing inductively coupled plasma mass spectrometry (ICP-MS). As a resultant of these efforts, West is now properly positioned to comply with the new <381> when enacted. Moreover, West has supported USP by providing extraction methods and analytical methods that will be incorporated in the new <381>. This work is an example of not only acting to ensure patients receive the safest products, but helping to lead the industry to achieve the same goal. As always, West fully supports customers in understanding and navigating regulatory landscapes such as these.

Visit the Analytical Services section of westpharma.com to learn more about the testing West has to offer.