ISO/TS 23565:2021

TECHNICAL ISO/TS
SPECIFICATION 23565
First edition
2021-10
Biotechnology — Bioprocessing
— General requirements and
considerations for equipment systems
used in the manufacturing of cells for
therapeutic use
Biotechnologie — Bioprocédés — Exigences et considérations
générales pour les systèmes d'équipement utilisés dans la fabrication
de cellules à usage thérapeutique
Reference number
© ISO 2021
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ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations .4
4.1 General . 4
4.2 Incorporating equipment and testing into the manufacturing workflow of cells for
therapeutic use . 5
4.3 Unit operation equipment systems . 6
4.4 Connecting to upstream or downstream processing equipment, or both . 6
4.5 Monitoring and surveillance software . 6
4.6 Impurity and toxicity contribution to final cells for therapeutic use . 6
4.7 Sterility and non-pyrogenicity . 6
5 Equipment overall performance characteristics and evaluation .7
5.1 General . 7
5.2 Description of performance characteristics . 7
5.3 Performance parameters and correlation to cell quality attributes . 8
6 Components of the equipment system . 8
6.1 Hardware . 8
6.1.1 General . 8
6.1.2 Physical integrity . 8
6.1.3 Physical strength . 9
6.1.4 Packaging . 9
6.1.5 Recovery of cells . 9
6.1.6 Validation of performance qualification . 9
6.1.7 Physical evaluation of equipment and cell sample interaction . 9
6.1.8 Damage to cells . 9
6.1.9 Impact to clean room environment . 10
6.1.10 Monitoring . 10
6.2 Equipment software for manufacturing of cells for therapeutic use . 10
6.3 Consumables . . . 11
6.3.1 General . 11
6.3.2 Biocompatibility . 11
6.3.3 Toxicity of chemical sterilants . 11
6.3.4 Toxicity of extracted and leached materials .12
6.3.5 Particulates .12
6.3.6 Stability of disposable single-use components .13
7 Documentation and notification of changes .13
7.1 Documentation . 13
7.1.1 General .13
7.1.2 Documentation for off-the-shelf equipment or instruments .13
7.1.3 Custom-designed supplier documentation package for equipment or
instruments . 14
8 Use and maintenance of equipment .14
8.1 Use of equipment . 14
8.2 Maintenance of equipment .15
Bibliography .16
iii
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
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iv
TECHNICAL SPECIFICATION ISO/TS 23565:2021(E)
Biotechnology — Bioprocessing — General requirements
and considerations for equipment systems used in the
manufacturing of cells for therapeutic use
1 Scope
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 incubators, etc.), and software to
control multiple equipment systems or multiple unit operations.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
batch
quantity of material regarded as a single unit, and having a unique reference
Note 1 to entry: Batch is primarily a processing term.
[SOURCE: ISO 15270:2008, 3.3]
3.2
cells for therapeutic use
product containing cells as the active substance
EXAMPLE A cell therapy medicinal product (allogenic, autologous, somatic, genetically modified), tissue
engineered product.
Note 1 to entry: For the purpose of this document, “cells” mean human cells and tissues of autologous as well as
allogeneic.
[SOURCE: ISO 21973:2020, 3.1, modified — The example has been replaced. Notes 2 and 3 to entry have
been deleted.]
3.3
consumable
tubing, filter, culture vessel, bag or bottle used to transfer, culture or act as a container for the biologics
or another consumable used in the production of cells for therapeutic use (3.2)
3.4
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.15) is taken to
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