Thursday, 14 March 2013


A new edition of the Pharmacopeial Forum (vol. 39, No. 2) has been published. In the new edition, the following general chapters of interest:

Chapter 1229.4 Sterilizing Filtration of Liquids

(Revision proposal target, USP37-NF32 1S)

The current general chapter Sterilization and Sterility Assurance of Compendial Articles 1211 will be split into several individual chapters. This chapter provides an overview of (1) various factors that affect the filtration process, (2) filtration conditions, (3) validation, (4) the filter integrity test, (5) when to test integrity, (6) prefiltration bioburden control, (7) responsibilities of the filter manufacturer and user, and (8) troubleshooting the filtration process.

Chapter 1229.10 Radiation Sterilization

(Revision proposal target, USP37-NF32 1S)

This proposed chapter provides an overview of radiation sterilization and its validation, including dose setting, material compatibility, and dose verification.

Posted by Tim Sandle