ASTM E1564-00

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Designation:E1564–00
Standard Guide for
Design and Maintenance of Low-Temperature Storage
Facilities for Maintaining Cryopreserved Biological
Materials
This standard is issued under the fixed designation E1564; 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
Storagefacilitiesformaintainingcryopreservedbiologicalmaterialsaregenerallycomprisedoftwo
types of low-temperature systems: (1) freezers that are cooled by mechanical refrigeration and (2)
freezers that are cooled passively with liquid nitrogen. Either system can be used for the storage of
frozen biological materials as long as it meets the criteria specific to the material being stored for
ensuring stability. Each system has its own unique handling requirements.
1. Scope E1565 Guide for Inventory Control and Handling of Bio-
logical Material Maintained at Low Temperatures
1.1 This guide covers recommended procedures for devel-
E1566 GuideforHandlingHazardousBiologicalMaterials
oping and maintaining low-temperature storage facilities for
in Liquid Nitrogen
freezers with mechanical refrigeration.
1.2 This guide covers recommended procedures for devel-
3. Terminology
oping and maintaining low-temperature storage facilities for
3.1 Definitions:
freezers cooled with liquid nitrogen.
3.1.1 cryogenic temperatures—temperaturesbeloworequal
1.3 This guide does not cover practices for preservation by
to−100°C.
freezing which are covered in Practice E1342.
3.1.2 mechanical refrigeration—a refrigeration system in
1.4 The values stated in SI units are to be regarded as
which cooling is provided by mechanical means such as a
standard.
compressor.
1.5 This standard does not purport to address all of the
3.1.3 passive refrigeration—arefrigerationsysteminwhich
safety problems, if any, associated with its use. It is the
cooling is provided by a refrigerant such as liquid nitrogen.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
4. Significance and Use
bility of regulatory limitations prior to use.
4.1 The proper design of low-temperature storage facilities
ensuresthatsensitivebiologicalmaterialsaremaintainedunder
2. Referenced Documents
conditions providing maximum storage stability.
2.1 ASTM Standards:
4.2 Properlydesignedandoperatedlow-temperaturestorage
E1342 Practice for Preservation by Freezing, Freeze-
facilities ensure that the handling of sensitive biological
Drying, and Low Temperature Maintenance of Bacteria,
materials at low temperatures does not compromise stability
Fungi,Protista,Viruses,GeneticElements,andAnimaland
(see Guide E1565).
Plant Tissues
4.3 Properly designed low-temperature storage facilities
ensure that adequate safeguards are provided to prevent unto-
ward events from compromising the stability of sensitive
ThisguideisunderthejurisdictionofASTMCommitteeE48onBiotechnology
biological materials.
and is the direct responsibility of Subcommittee E48.02 on Characterization and
Identification of Biological Systems.
5. Procedure
Current edition approved September 10, 2000. Published December 2000.
Originally published as E1564-93. Last previous edition E1564-93.
5.1 Low-Temperature Mechanical Freezers:
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.1.1 Ensure that adequate dedicated electrical power is
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
available to support the number of mechanical freezers re-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. quired in the facility.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1564–00
5.1.2 Provide for emergency electrical power to maintain maintain a working temperature at the top of the unit
the freezers when commercial power disruptions occur. of−130°C or below. To validate the freezer, measure the
5.1.3 Place the freezers in a temperature- and humidity- temperatureatthetopwiththefreezeropen,andraisethelevel
controlled area with adequate ventilation. of the liquid nitrogen until the temperature remains at or
5.1.4 Obtainasourceofservicesupportfortherefrigeration below−130°C for at least 1 h. The requirements for storing
systems that is reliable and can respond to mechanical prob- material in the vapor phase shall be determined prior to
lems rapidly. An alternative source should also be available. purchasing a liquid nitrogen freezer since not all freezer
5.1.5 When selecting mechanical freezers, be sure that the designs are amenable to all vapor storage.
lowest attainable temperature of the unit is cold enough to 5.2.7 Avoid using small liquid nitrogen units for permanent
ensure the stability of the biological material to be stored in storage since they require constant surveillance and increase
them. the probability of problems occurring.
5.1.6 Thetemperatureofmechanicalfreezersshallbemoni- 5.2.8 To ensure a constantly available source of liquid
tored daily to ensure that consistently low temperatures are nitrogen, a bulk storage tank should be dedicated to liquid
maintained. Most units have temperature-sensing devices built nitrogenstorageonly.Thiscanbeaportableunitlocatedwithin
in that allow both control and monitoring of the freezer the facility, or an external stand tank with insulated piping for
temperature. These internal units can malfunction and fool transporting the liquid nitrogen to the freezers. Solenoids and
alarm systems.Atemperature detecting probe should therefore pr
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