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BS ISO 24088-1:2022

$142.49

Biotechnology.Biobanking of microorganisms – Bacteria and archaea

Published By Publication Date Number of Pages
BSI 2022 28
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PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements
4.1 General
4.2 Legal requirements
13 4.3 Health and safety
4.3.1 General
4.3.2 Chemical safety
4.3.3 Biosafety and biorisk
14 4.3.4 Personal protective equipment
4.4 Biosecurity and access
4.4.1 General
15 4.4.2 Access to biosecure area(s)
4.5 Relocation of microbial materials
5 Personnel
16 6 Facilities
6.1 General
6.2 Biosafety cabinets
6.3 Back-up storage facilities
7 Critical equipment for microbial biobanking
7.1 General
7.2 Calibration
7.3 Incubators
7.4 Refrigerators
17 7.5 Ultra-low temperature electrically powered storage
7.6 Liquid nitrogen storage system/liquid nitrogen supply
7.7 Freeze dryer
7.8 Automated storage systems
7.9 Autoclave
18 8 Process requirements
8.1 Acquisition or deposit
8.1.1 General
8.1.2 Review of requests to deposit material(s)
19 8.1.3 Decision regarding requests to deposit materials
8.1.4 Confirmation of materials and associated data
8.2 Authentication
8.3 Purity and passage control
8.3.1 General
8.3.2 Contamination with other microorganisms
20 8.3.3 Passage control
8.4 Preparation, preservation and storage
8.4.1 General
8.4.2 Preparation of distribution stock and master stock
22 8.4.3 Preparation, preservation and storage of derivatives from microorganism(s)
8.5 Distribution
8.5.1 General
8.5.2 Review and acceptance of distribution requests
8.5.3 Distribution agreement
8.6 Packaging
23 8.7 Transport
9 Complaint management
10 Management of information and data
10.1 Information system requirements
10.1.1 General
10.1.2 Microbial material identification system
10.1.3 Minimum data set
10.1.4 Recommended data set for microbial materials
24 10.1.5 Microbial biobank accession number
10.1.6 Production lot number
10.1.7 Location
10.2 Inventory management
11 Quality control, validation and verification
11.1 General
11.2 Quality control of processes, microbial materials and associated data
25 11.3 Validation and verification of methods
12 Reporting
26 Bibliography
BS ISO 24088-1:2022
$142.49