ISO 24088-1:2022

INTERNATIONAL ISO
STANDARD 24088-1
First edition
2022-07
Biotechnology — Biobanking of
microorganisms —
Part 1:
Bacteria and archaea
Biotechnologie — Biobanque des microorganismes —
Partie 1: Bactéries et archées
Reference number
© ISO 2022
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Published in Switzerland
ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
4.1 General . 4
4.2 Legal requirements . 4
4.3 Health and safety . . 5
4.3.1 General . 5
4.3.2 Chemical safety . . 5
4.3.3 Biosafety and biorisk . 5
4.3.4 Personal protective equipment . 6
4.4 Biosecurity and access . 6
4.4.1 General . 6
4.4.2 Access to biosecure area(s) . 7
4.5 Relocation of microbial materials . 7
5 Personnel . 7
6 Facilities . 8
6.1 General . 8
6.2 Biosafety cabinets . . 8
6.3 Back-up storage facilities . 8
7 Critical equipment for microbial biobanking . 8
7.1 General . 8
7.2 Calibration . 8
7.3 Incubators . 8
7.4 Refrigerators . 9
7.5 Ultra-low temperature electrically powered storage . 9
7.6 Liquid nitrogen storage system/liquid nitrogen supply . 9
7.7 Freeze dryer . 9
7.8 Automated storage systems . 9
7.9 Autoclave . 9
8 Process requirements .10
8.1 Acquisition or deposit . 10
8.1.1 General . 10
8.1.2 Review of requests to deposit material(s) . 10
8.1.3 Decision regarding requests to deposit materials . 11
8.1.4 Confirmation of materials and associated data . 11
8.2 Authentication . 11
8.3 Purity and passage control . 11
8.3.1 General . 11
8.3.2 Contamination with other microorganisms .12
8.3.3 Passage control .12
8.4 Preparation, preservation and storage .12
8.4.1 General .12
8.4.2 Preparation of distribution stock and master stock .12
8.4.3 Preparation, preservation and storage of derivatives from microorganism(s) . 14
8.5 Distribution . 14
8.5.1 General . 14
8.5.2 Review and acceptance of distribution requests . 14
8.5.3 Distribution agreement . 14
iii
8.6 Packaging . 15
8.7 Transport . 15
9 Complaint management .15
10 Management of information and data .15
10.1 Information system requirements . 15
10.1.1 General .15
10.1.2 Microbial material identification system . 15
10.1.3 Minimum data set . 15
10.1.4 Recommended data set for microbial materials . 16
10.1.5 Microbial biobank accession number . 16
10.1.6 Production lot number . 16
10.1.7 Location . 16
10.2 Inventory management . 16
11 Quality control, validation and verification .16
11.1 General . 16
11.2 Quality control of processes, microbial materials and associated data . 16
11.3 Validation and verification of methods . 17
12 Reporting .17
Bibliography .18
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in li
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