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BSI PD ISO/TS 23565:2021

BSI PD ISO/TS 23565:2021

$142.49

Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Published By Publication Date Number of Pages
BSI 2021 26
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This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use.

This document gives guidance on the design, use and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e. supplier or user, and phase of involved task, i.e. design, use or maintenance.

This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It is applicable to devices used for the purpose of monitoring equipment status.

It does not apply to:

  • processing equipment for cells for therapeutic use used at the point of care;

  • devices used for analytical purposes;

  • biosafety cabinets, general cell culture equipment (such as CO 2 incubators, etc.), and software to control multiple equipment systems or multiple unit operations.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 1 Scope
2 Normative references
3 Terms and definitions
10 4 General considerations
4.1 General
11 4.2 Incorporating equipment and testing into the manufacturing workflow of cells for therapeutic use
12 4.3 Unit operation equipment systems
4.4 Connecting to upstream or downstream processing equipment, or both
4.5 Monitoring and surveillance software
4.6 Impurity and toxicity contribution to final cells for therapeutic use
4.7 Sterility and non-pyrogenicity
13 5 Equipment overall performance characteristics and evaluation
5.1 General
5.2 Description of performance characteristics
14 5.3 Performance parameters and correlation to cell quality attributes
6 Components of the equipment system
6.1 Hardware
6.1.1 General
6.1.2 Physical integrity
15 6.1.3 Physical strength
6.1.4 Packaging
6.1.5 Recovery of cells
6.1.6 Validation of performance qualification
6.1.7 Physical evaluation of equipment and cell sample interaction
6.1.8 Damage to cells
16 6.1.9 Impact to clean room environment
6.1.10 Monitoring
6.2 Equipment software for manufacturing of cells for therapeutic use
17 6.3 Consumables
6.3.1 General
6.3.2 Biocompatibility
6.3.3 Toxicity of chemical sterilants
18 6.3.4 Toxicity of extracted and leached materials
6.3.5 Particulates
19 6.3.6 Stability of disposable single-use components
7 Documentation and notification of changes
7.1 Documentation
7.1.1 General
7.1.2 Documentation for off-the-shelf equipment or instruments
20 7.1.3 Custom-designed supplier documentation package for equipment or instruments
8 Use and maintenance of equipment
8.1 Use of equipment
21 8.2 Maintenance of equipment
22 Bibliography

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BSI PD ISO/TS 23565:2021
$142.49