Sunday, 2 October 2016

Pharmeuropa 28.3


A new edition of Pharmeuropa has been issued (28.3). Pharmeuropa is an EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months.


Items of interest are:

3.2.3    Sterile plastic containers for human blood and blood components

Tests: the use of water for injections R has been replaced by water R (the use of sterilised water for injection is not considered suitable for testing purposes); this change is in accordance with general chapter 3.1.1.1. Materials based on plasticised poly(vinylchloride) for containers for human blood and blood components.

Pyrogens: to avoid animal testing, in accordance with EU Directive 2010/63/EU and the policy of the European Pharmacopoeia Commission, the test for pyrogens has been replaced by the test for bacterial endotoxins.

Packaging, Labelling: the requirements have been revised.


3.2.9    Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders

The scope of this general chapter has been expanded to include coated closures, bi-layer seals and lubricated closures to reflect better the range of closures on the market. More details are provided in the Identification section for greater clarity.

Identification A (IR): the amount of rubber required is described as ‘an appropriate amount’ to allow more flexibility.


Identification B (total ash): an indication has been added to explain how to proceed with samples that are not subjected to steam sterilisation; an indication has been added to allow compliance with the limit for a specific rubber type, when available.
Solution S: the washing step performed before the preparation of solution S has been deleted; the procedure for the measurement of the temperature during autoclaving has been clarified.

Appearance of solution S: limits for nephelometric measurements have been included.
Acidity or alkalinity: clarification has been added on when to perform the titration.
Extractable zinc: the description of the test solution preparation has been revised to be more specific.


Self-sealing test: a requirement to use a vial that fits with the closure has been added

0008    Water, Purified

In line with the Ph. Eur. implementation strategy of the ICH Q3D Guideline on Elemental impurities, the test for heavy metals (2.4.8) is deleted.

However, to retain the aspect of control for elemental impurities, the ‘Purified water in bulk’ section of the monograph is revised to address the situation where purified water in bulk does not comply with the requirements for conductivity prescribed in Water for injections (0169) in bulk.

Posted by Dr. Tim Sandle