Saturday, 11 July 2015

Pharmacopeial Forum 41(2)

A new edition of the Pharmacopeial Forum has been issued. Of interest is proposed changes to the following general chapters:

<55>    Biological Indicators – Resistance Performance
(Revision proposal target, USP39-NF34 1st Supplement)

USP proposes revisions to this chapter to align its content with the new series of Sterilization of Compendial Articles <1229> chapters.

<191>  Identification Tests - General
(Revision proposal target, USP39-NF34 1st Supplement)

USP propose to modernise this chapter by providing an option of using instrumental identification methods in lieu of traditional wet-chemistry procedures.

<381>  Elastomeric Closures for Injections
(Revision proposal target, USP39-NF34 1st Supplement)

Due to the impending omission of Heavy Metals <231>, the USP Packaging, Storage, and Distribution Expert Committee is proposing the following revision while the Expert Committee works to modernize the chapter. The modernized chapter will include specific testing requirements for elastomeric materials of construction and elastomeric materials used in packaging systems. As part of this modernization effort, the elemental impurities tests for elastomeric materials and materials used in final packaging systems will also be updated.

<507>Protein Determination Procedures [NEW]
(Revision proposal target, USP39-NF34 1st Supplement)

A new general test chapter. The chapter contains multiple validated methods for the measurement of total protein, providing users with options depending on their sample matrix and measurement purpose.

<1229.5>Biological Indicators for Sterilization [NEW]
(Revision proposal target, USP39-NF34 1st Supplement)

USP proposes this new general information chapter as an addition to the <1229> family of chapters. The content on the use of biological indicators (BIs) in this proposal is consistent with that presented in that series of chapters. This proposed chapter contains information on BIs with respect to their types, characterization, and selection for specific types of sterilization, as well as responsibilities of the BI manufacturer and user.

This chapter will replace Biological Indicators for Sterilization <1035>, which will be proposed for deletion in the next issue of Pharmacopeial Forum.

<1229.9>Physiochemical Integrators and Indicators for Sterilization [NEW]
(Revision proposal target, USP39-NF34 1st Supplement)

A new general chapter as an addition to the Sterilization of Compendial Articles <1229> family of chapters. This general chapter will replace Sterilization—Chemical and Physiochemical Indicators and Integrators <1209> and will provide additional information on the use of chemical and physicochemical integrators and indicators under the <1229> parent chapter, consistent with the <1229> sterilization series of chapters. General chapter <1209> will be omitted in the next issue of Pharmacopeial Forum.


<1229.12>New Sterilization Methods[NEW]
(Revision proposal target, USP39-NF34 1st Supplement)

A new general chapter as an addition to the Sterilization of Compendial Articles <1229> family of sterilization chapters. Commonly available sterilization processes are intended for the elimination of microorganisms from the materials subjected to them. However, certain situations may arise in which the user may need to develop and implement a new or novel sterilization process. This chapter provides information on the important steps to be considered for such a process.

Posted by Tim Sandle