ASTM E1565-00

Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

SCOPE
1.1 This guide covers recommended procedures for handling material stored at low temperatures in mechanical freezers and liquid nitrogen freezers.
1.2 This guide covers recommendation for implementing procedures for ensuring adequate inventory control.
1.3 This guide covers recommendations for implementing procedures for safeguarding material stored at low temperatures.
1.4 This guide does not cover the development or maintenance of equipment and facilities for low-temperature storage which are covered in Practice E1564.
1.5 This guide does not cover practices for preservation by freezing which are covered in Practice E1342.  
1.6 The values stated in SI units are to be regarded as the standard.
1.7  This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Sep-2000
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 27.200 - Refrigerating technology
• Technical Committee: E48 - Bioenergy and Industrial Chemicals from Biomass

Relations

• Replaced By: ASTM E1565-00(2006) - Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
• Effective Date: 01-Nov-2006
• Referred By: ASTM E2363-23 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
• Effective Date: 10-Sep-2000
• Referred By: ASTM E1564-00(2019) - Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
• Effective Date: 10-Sep-2000

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E1565–00
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) 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
proceduresandthedevelopmentofadequatesafeguards.Becauseofthesensitivityofmanybiological
materials,caremustbetakenthatcriticaltemperaturesarenotcompromisedduringretrievalandother
activities involving handling of the material. Safeguards must also be established to ensure both
adequatetemperaturesatalltimesduringstorageandthatinventorycontrolprovidesamechanismfor
ease of retrieval.
1. Scope E 1342 Practice for Preservation by Freezing, Freeze-
Drying, and Low Temperature Maintenance of Bacteria,
1.1 This guide covers recommended procedures for han-
Fungi,Protista,Viruses,GeneticElements,andAnimaland
dling material stored at low temperatures in mechanical freez-
Plant Tissues
ers and liquid nitrogen freezers.
E1564 Guide for Design and Maintenance of Low Tem-
1.2 This guide covers recommendations for implementing
perature Storage Facilities for Maintaining Cryopreserved
procedures for ensuring adequate inventory control.
Biological Materials
1.3 This guide covers recommendations for implementing
E1566 GuideforHandlingHazardousBiologicalMaterials
procedures for safeguarding material stored at low tempera-
in Liquid Nitrogen
tures.
1.4 This guide does not cover the development or mainte-
3. Terminology
nance of equipment and facilities for low-temperature storage
3.1 Definitions:
which are covered in Guide E1564.
3.1.1 cryogenic temperatures—temperaturesbeloworequal
1.5 This guide does not cover practices for preservation by
to−100°C.
freezing which are covered in Practice E1342.
3.1.2 liquid nitrogen freezers—freezers that operate by a
1.6 The values stated in SI units are to be regarded as the
refrigeration system in which cooling is provided by a refrig-
standard.
erant such as liquid nitrogen.
1.7 This standard does not purport to address all of the
3.1.3 mechanical freezers—freezersthatoperatebyarefrig-
safety problems, if any, associated with its use. It is the
eration system in which cooling is provided by mechanical
responsibility of the user of this standard to establish appro-
means such as a compressor.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Significance and Use
2. Referenced Documents 4.1 The proper handling of material stored at low tempera-
2 tures ensures that the stability of sensitive biological materials
2.1 ASTM Standards:
is not comprised.
4.2 Properly designed inventory control systems ensure the
ThisguideisunderthejurisdictionofASTMCommitteeE48onBiotechnology maximum use of freezer space, that all material can be located
and is the direct responsibility of Subcommittee E48.02 on Characterization and
easily, and that any item is retrieved easily without compro-
Identification of Biological Systems.
mising the stability of other items in the freezer.
Current edition approved Sept. 10, 2000. Published December 2000.
Originally published as E1565-93. Last previous edition E1565-93.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1565–00
4.3 Properlydesignedsafetyandsecurityproceduresensure 5.1.8 Store seed material in a separate freezer to ensure that
that material stored at low temperatures is not comprised itisnotcompromisedbyrepeatedhandlingduringtheretrieval
during storage, and that if material is lost due to freezer failure of working stocks.
or operational problems, replacement material is available (see 5.2 Safekeeping:
Guide E1566). 5.2.1 Store some vials of working stock or seed material, or
both, separate from the main lot of material for safekeeping.
5.2.2 Maintain safekeeping material in a separate freezer
5. Procedures
and in a remote location, if possible.
5.1 Inventory Control and Handling:
5.2.3 Do not rely on seed material alone for safekeeping, as
5.1.1 Prior to storing frozen material, set up a system of
it is irreplaceable. Materia
...