GB/T 40365-2021General guide for cell sterility testing (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.

1 Scope

This document specifies the general requirements, method selection and process control for cell sterility testing.

This document is applicable to the detection and control of bacteria, fungi, viruses and mycoplasma in cells.

2 Normative references

The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 19489 Laboratory Biosafety General Requirements

3 Terms and definitions

The following terms and definitions apply to this document.

4 Abbreviations

The following abbreviations apply to this document.

ITS1. The first internal transcribed spacer of ribosomal DNA (InternalTranscribedSpacer-1)

ITS2. The second internal transcribed spacer of ribosomal DNA (InternalTranscribedSpacer-2)

MNP. Polynucleotide Polymorphism (MutipleNucleotidePolymorphism)

PCR. Polymerase Chain Reaction (PolymeraseChain Reaction)

16SrRNA. 16S ribosomal RNA (16SRibosomalRibonucleicAcid)

5 General requirements

5.1 The risk assessment of cells should be carried out based on the cell source, potential contamination exposure history, the intended use of the cell and the environment in which it is located.

The factors to be considered include but are not limited to the following aspects.

a) The source of the cell sample should be considered. Cells from different species are likely to carry potential microorganisms;

b) Related contamination testing should be carried out according to the purpose of cell use;

c) The environmental factors in the whole cycle of cell preparation and cell culture should be considered. Evaluate possible contamination based on exposure history, such as The animal serum of the cultured cells may be contaminated with specific microorganisms.

5.2 Determine the most likely type of microbial contamination based on risk assessment, evaluate the applicability of existing inspection methods, and select samples for testing. Choose the appropriate method.