CEI-MS-06 — Sterility testing of peptide preparations presented in sealed vials
Sterility testing of peptide preparations presented in sealed vials
§1Scope
§1.1Scope
Applies to lyophilised or solution presentations intended for parenteral administration. The Institute records that no supplier in its assessment set reports a sterility determination for research-supply material.
§2Principle
A sample is transferred aseptically to growth media that support a wide range of bacteria and fungi, incubated, and examined for growth. Membrane filtration is preferred where the preparation is filterable, because it separates the analyte from the medium and removes any inherent antimicrobial activity of the peptide itself — a real consideration for host-defence peptides such as LL-37, which are antimicrobial by design and will produce a false negative in direct inoculation.[1,2]
§3Apparatus and reagents
§3.1Apparatus
- Grade A unidirectional-airflow workstation within a Grade B background, or a validated isolator
- Sterility-test canisters or a closed filtration system with 0.45 µm membranes
- Incubators at 22.5 ± 2.5 °C and 32.5 ± 2.5 °C
- Environmental monitoring plates and settle plates
§3.2Reagents and reference materials
- Fluid thioglycollate medium
- Soya-bean casein digest medium
- Sterile rinsing fluid appropriate to the preparation
- Growth-promotion challenge organisms per the pharmacopoeial list
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.
- 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
- United States Pharmacopeial Convention. General Chapter ⟨85⟩ Bacterial Endotoxins Test. 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.