CEI-MS-06 — procedure

§4Procedure

The procedure below is written in the second person, which is the only place in the Institute's document set where that register is used. A procedure is an instruction and is written as one.

1. Establish the number of containers to be tested from the batch size per the pharmacopoeial table.
2. Confirm growth promotion of both media with the specified challenge organisms within the stated incubation period.
3. Perform a method-suitability determination: inoculate the media with challenge organisms in the presence of the product to confirm that the product does not inhibit growth. For any peptide with intrinsic antimicrobial activity this step is not a formality and will frequently fail direct inoculation.
4. Transfer the sample aseptically. Where filtration is used, rinse the membrane with not less than three volumes of rinsing fluid before transfer to medium.
5. Incubate for 14 days, examining at intervals and recording each observation.
6. Record environmental monitoring for the duration of the test session.
7. Report the result, the number of containers tested, the method used, and the outcome of the method-suitability determination.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. United States Pharmacopeial Convention. General Chapter ⟨71⟩ Sterility Tests. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.