ISO 24088-1:2022
(Main)Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea
Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea
This document specifies requirements for the biobanking of bacteria and archaea. It includes management of microbial material associated data as well as biosafety and biosecurity requirements. This document is applicable to all organizations performing biobanking with bacteria and archaea used for research and development. This document does not apply to processing methods for microbial materials intended for food/feed production, laboratories undertaking food/feed analysis or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
Biotechnologie — Biobanque des microorganismes — Partie 1: Bactéries et archées
General Information
Standards Content (Sample)
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 24088-1:2022(E)
© ISO 2022
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ISO 24088-1:2022(E)
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© ISO 2022
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ISO 24088-1:2022(E)
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
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ISO 24088-1:2022(E)
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
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ISO 24088-1:2022(E)
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 liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/
iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
A list of all parts in the ISO 24088 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO 24088-1:2022(E)
Introduction
Many countries around the world have microbial biobanks that perform biobanking activities according
to their own guidelines. Microbial biobanks face challenges such as the genetic mutation of strains,
microbial contamination, misidentification and loss of viability. These challenges can impact users’
research results with consequent serious socio-economic losses, affecting the bioindustry, society
in general and other stakeholders. It is imperative that internationally standardized operational and
management requirements address these common problems.
This document has been developed to promote confidence in microbial biobanking. It contains the
requirements to enable biobanks to demonstrate their competent operation and the ability to provide
authenticated microbial materials and associated data of appropriate quality for research and
development.
This is intended to be achieved by the planning and implementation of policies, processes and
procedures relevant to the life cycle of microbial material and associated data within the scope/control
of the microbial biobank.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
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INTERNATIONAL STANDARD ISO 24088-1:2022(E)
Biotechnology — Biobanking of microorganisms —
Part 1:
Bacteria and archaea
1 Scope
This document specifies requirements for the biobanking of bacteria and archaea. It includes
management of microbial material associated data as well as biosafety and biosecurity requirements.
This document is applicable to all organizations performing biobanking with bacteria and archaea used
for research and development.
This document does not apply to processing methods for microbial materials intended for food/feed
production, laboratories undertaking food/feed analysis or therapeutic use.
NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to
specific topics covered in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15190:2020, Medical laboratories — Requirements for safety
ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
ISO 21710:2020, Biotechnology — Specification on data management and publication in microbial resource
centers
ISO 45001:2018, Occupational health and safety management systems — Requirements with guidance for
use
WHO. Laboratory biosafety manual. Fourth edition. World Health Organization, 2020
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20387:2018 and the following
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 https:// www .electropedia .org/
3.1
associated data
any information affiliated with microbial material (3.12) including biosafety (3.2) conditions but not
limited to collection, taxonomic, deposit history, specific authorization and provider data
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ISO 24088-1:2022(E)
3.2
biosafety
practices and controls that reduce the risk of unintentional exposure or release of biological materials
[SOURCE: ISO 35001:2019, 3.22]
3.3
biosecurity
institutional and personal security measures and procedures designed to prevent the loss, theft,
misuse, diversion or intentional/unintentional release of pathogens, genetically modified organisms,
toxin-producing organisms, or parts thereof, as well as such toxins that are held, transferred and/or
supplied by the biobank
[SOURCE: ISO 20387:2018, 3.9]
3.4
catalogue
systematically arranged list or record, often including associated data (3.1)
Note 1 to entry: This catalogue can be printed and/or available online.
[SOURCE: ISO 20387:2018, 3.10, modified — “associated data" has replaced “descriptive information”
and Note 1 to entry has been added.]
3.5
deposit
process of transferring possession and/or custody of microbial material (3.12) and/or associated data
(3.1) from a provider (3.15) to a microbial biobank (3.11)
3.6
distribution stock
microbial material (3.12) for distribution to recipients or users
[11]
[SOURCE: OECD. Best practice guidelines for biological resource centres, 2007 ]
3.7
genomic stability
conditions produced by the absence of molecular evolution in a microbial culture
3.8
master stock
microbial material (3.12), used to produce the distribution stock (3.6)
3.9
material accession agreement
MAA
material acquisition agreement
documented agreement governing the transfer of microbial material (3.12) and associated data (3.1)
between a microbial biobank (3.11) and another/other party/parties such as a provider (3.15)
Note 1 to entry: An MAA documents basic data, such as place and date of sampling, in a standardized format, and
specifies the role, rights and duties of each party.
Note 2 to entry: MAA is a synonym of material deposit agreement (MDA). It is normally put in place by a microbial
biobank.
Note 3 to entry: The definition was derived from ISO 21710:2020, 3.13, with the change that an MAA is not always
a contractual document.
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ISO 24088-1:2022(E)
3.10
material transfer agreement
MTA
documented agreement governing the transfer of microbial material (3.12) and associated data (3.1)
between a microbial biobank (3.11) and a recipient
Note 1 to entry: All the documents can be designated as MTA as long as they contain information about the in
situ origin or the source of the microbial material and associated data, information about the provider (3.15) and
recipient, and information that defines the limits of the use of the microbial material and associated data.
Note 2 to entry: An MTA can include requirements for the microbial material being deposited, e.g. to meet the
need of the provider country or country of origin, particularly those that are the parties of the Convention of
Biological Diversity (CBD) and Nagoya Protocol (NP).
Note 3 to entry: The definition was derived from ISO 21710:2020, 3.19, with the change that an MTA is not always
a contractual document.
3.11
microbial biobank
MRC
microbial resource centre
microbial biological resource centre
microbial BRC
microbial culture collection
legal entity or part of a legal entity that performs biobanking with microbial material (3.12) and
associated data (3.1)
[SOURCE: ISO 21710:2020, 3.18, modified — “microbial biobank” has replaced “MRC” as the preferred
term and the term “microbial culture collection” has been added.]
3.12
microbial material
microorganism itself or any substance(s) or part(s) obtained from a microorganism, and any complexes
or associations between microorganisms
Note 1 to entry: This comprises all prokaryotes (archaea and bacteria), some eukaryotic organisms (fungi, algae,
protozoa), any association between the latter (e.g. lichens), non-cellular entities (e.g. viruses), their replicable
parts and other derived materials (e.g. genomes, plasmids, cDNA). It also includes some viable but not yet
culturable microorganisms.
[SOURCE: ISO 21710:2020, 3.17, modified — “microorganism itself or any substance(s) or part(s)” has
replaced “any substance(s) derived or part” in the definition and “yeasts” have been deleted from the
note.]
3.13
minimum data set
MDS
collection of technical and scientific data digitized in specific fields of a database, which is necessary to
distinguish unambiguously a particular microbial material (3.12) and provides a minimum amount of
information available for each accession in a microbial biobank (3.11)
Note 1 to entry: Microbial materials for which this information is not available cannot be inserted into the
catalogue (3.4) since they lack some essential data.
[SOURCE: ISO 21710:2020, 3.15, modified — “a microbial biobank” has replaced “an MRC” and the Note
to entry has been reworded.]
3.14
passage number
number of serial subcultures that an isolate has been grown from the original isolation
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ISO 24088-1:2022(E)
3.15
provider
depositor
person or entity from whom/which a microbial material (3.12) and/or associated data (3.1) is received
or acquired for biobanking
[SOURCE: ISO 20387:2018, 3.41, modified — “a microbial” has replaced “the biological” and Note 1 to
entry has been deleted.]
3.16
purity
absence of impurity or contaminants in a substance
3.17
recommended data set
RDS
collection of data that includes useful information for an improved description of the functions and
properties of a microbial material (3.12)
Note 1 to entry: This includes optional data fields for use by the microbial biobank (3.11) in the catalogue (3.4),
when available.
3.18
safe deposit
service for long-term preservation of microorganisms with distributing restriction(s) at the discretion
of the provider (3.15)
Note 1 to entry: Microbial biobanks (3.11) maintain the biological strain(s) and ensure their viability (3.19) but the
authenticity of those strain(s) is the provider’s responsibility. All information related to a safe deposit is treated
as confidential. Access to this type of strain is granted only on written request of the provider.
Note 2 to entry: Culture collections with International Depository Authority status have the possibility to deposit
[8]
(3.5) microorganisms as a part of a patenting process according to the Budapest Treaty .
3.19
viability
ability to survive or live successfully
4 General requirements
4.1 General
The microbial biobank shall meet the requirements described in ISO 20387, in addition to those in this
document. ISO/TR 22758 can be used as additional reference for the implementation of ISO 20387.
Microbial biobanks that manage microorganisms shall identify the processes necessary for the microbial
biobank operating system and determine the criteria and methods used to check the operational status
appropriate to the characteristics of each microbial cohort.
4.2 Legal requirements
The microbial biobank shall retain documented information that is relevant to comply with national
and international legislation. This can include:
— evidence of compliance with applicable health and safety requirements;
— microorganism risk classification;
— quarantine requirements;
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ISO 24088-1:2022(E)
— intellectual property rights;
— international treaties;
— access and benefit-sharing including microbial material and associated data access exchange and
transfer.
4.3 Health and safety
4.3.1 General
The microbial biobank or the legal entity of which it is a part shall ensure that health and safety
procedures conform to ISO 20387:2018. 6.2.1.5.
The microbial biobank shall define the biosafety level in accordance with the WHO’s Laboratory
Biosafety Manual and shall manage facilities and activities accordingly.
Personal protective equipment (PPE) required to mitigate the risk according to the relevant biosafety
level shall be used when collecting, transporting and/or processing samples of microbiological origin.
NOTE Appropriate measures for each biosafety level and for each dangerous pathogen are given in
Reference [9].
4.3.2 Chemical safety
The microbial biobank shall establish, document and implement policies and procedures concerning
the storage, handling, use and disposal of chemicals, taking into account the relevant regulations of
each country or region in which the microbial biobank operates.
Handling chemicals related to biobank activities can include but is not limited to extraction, synthesis,
industrial production, transportation, use and disposal.
The safety data sheet (SDS) for all chemicals used by the microbial biobank shall be prominently
displayed or readily available.
4.3.3 Biosafety and biorisk
The biobank should conform to ISO 35001 or the WHO’s Laboratory Biosafety Manual when handling
biological material contaminated with pathogens.
The biobank shall ensure that risks to health are managed effectively, including consideration for
preventive and protective measures. Personnel shall be medically examined periodically according to
exposure and risk.
The requirements of the personnel health programme, including requirements for record management
and confidentiality, shall be determined by a biosafety risk assessment.
The biobank shall:
a) establish and implement a vaccination policy as part of
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