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.
(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)
Posted by Tim Sandle
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