The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and Containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
The new structure of Section 3. will be published in the 10th Edition of the Ph. Eur. which will enter into force on 1 January 2020.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology