ASTM E1565-00(2019)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1565 − 00 (Reapproved 2019)
Standard Guide for
Inventory Control and Handling of Biological Material
Maintained at Low Temperatures
This standard is issued under the fixed designation E1565; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The stability of biological material stored at low temperatures is dependent on proper handling
procedures and the development of adequate safeguards. Because of the sensitivity of many biological
materials, care must be taken that critical temperatures are not compromised during retrieval and other
activities involving handling of the material. Safeguards must also be established to ensure both
adequate temperatures at all times during storage and that inventory control provides a mechanism for
ease of retrieval.
1. Scope Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This guide covers recommended procedures for han-
Barriers to Trade (TBT) Committee.
dling material stored at low temperatures in mechanical freez-
ers and liquid nitrogen freezers.
2. Referenced Documents
1.2 This guide covers recommendations for implementing
2.1 ASTM Standards:
procedures for ensuring adequate inventory control.
E1342 Practice for Preservation by Freezing, Freeze-Drying,
1.3 This guide covers recommendations for implementing
and Low Temperature Maintenance of Bacteria, Fungi,
procedures for safeguarding material stored at low tempera-
Protista, Viruses, Genetic Elements, and Animal and Plant
tures.
Tissues (Withdrawn 2011)
E1564 Guide for Design and Maintenance of Low-
1.4 This guide does not cover the development or mainte-
Temperature Storage Facilities for Maintaining Cryopre-
nance of equipment and facilities for low-temperature storage
served Biological Materials
which are covered in Guide E1564.
E1566 Guide for Handling Hazardous Biological Materials
1.5 This guide does not cover practices for preservation by
in Liquid Nitrogen
freezing which are covered in Practice E1342.
1.6 The values stated in SI units are to be regarded as
3. Terminology
standard. No other units of measurement are included in this
3.1 Definitions:
standard.
3.1.1 cryogenic temperatures, n—temperatures below or
1.7 This standard does not purport to address all of the
equal to −100°C.
safety concerns, if any, associated with its use. It is the
3.1.2 liquid nitrogen freezers, n—freezers that operate by a
responsibility of the user of this standard to establish appro-
refrigeration system in which cooling is provided by a refrig-
priate safety, health, and environmental practices and deter-
erant such as liquid nitrogen.
mine the applicability of regulatory limitations prior to use.
3.1.3 mechanical freezers, n—freezers that operate by a
1.8 This international standard was developed in accor-
refrigeration system in which cooling is provided by mechani-
dance with internationally recognized principles on standard-
cal means such as a compressor.
ization established in the Decision on Principles for the
1 2
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture For referenced ASTM standards, visit the ASTM website, www.astm.org, or
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee E55.13 on Process Evaluation and Control. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Feb. 1, 2019. Published March 2019. Originally the ASTM website.
approved in 1993. Last previous edition approved in 2014 as E1565 – 00 (2014). The last approved version of this historical standard is referenced on
DOI: 10.1520/E1565-00R19. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1565 − 00 (2019)
4. Significance and Use 5.1.7 When boxes are used for storage in liquid nitrogen,
place a small number of working vials in an easily accessible
4.1 The proper handling of material stored at low tempera-
location, leaving the majority of vials untouched in the colder
tures ensures that the stability of sensitive biological materials
portion of the freezer.
is not comprised.
5.1.8 Store seed material in a separate freezer to ensure that
4.2 Properly designed inventory control systems ensure the
it is not compromised by repeated handling during the retrieval
maximum use of freezer space, that all material can be located
of working stocks.
easily, and that any item is retrieved easily without compro-
5.2 Safekeeping:
mising the stability of other items in the freezer.
5.2.1 Store some vials of working stock or seed material, or
4.3 Properly designed safety and security procedures ensure
both, separate from the main lot of material for safekeeping.
that material stored at low temperatures is not com
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