ASTM E1564-00(2006)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E1564 − 00(Reapproved 2006)
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 (´) 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 Scope Tissues (Withdrawn 2011)
E1565Guide for Inventory Control and Handling of Bio-
1.1 This guide covers recommended procedures for devel-
logical Material Maintained at Low Temperatures
oping and maintaining low-temperature storage facilities for
E1566Guide for Handling Hazardous Biological Materials
freezers with mechanical refrigeration.
in Liquid Nitrogen
1.2 This guide covers recommended procedures for devel-
oping and maintaining low-temperature storage facilities for
3. Terminology
freezers cooled with liquid nitrogen.
3.1 Definitions:
1.3 This guide does not cover practices for preservation by
3.1.1 cryogenic temperatures—temperatures below or equal
freezing which are covered in Practice E1342.
to−100°C.
1.4 The values stated in SI units are to be regarded as
3.1.2 mechanical refrigeration—a refrigeration system in
standard.
which cooling is provided by mechanical means such as a
compressor.
1.5 This standard does not purport to address all of the
safety problems, if any, associated with its use. It is the
3.1.3 passive refrigeration—a refrigeration system in which
responsibility of the user of this standard to establish appro-
cooling is provided by a refrigerant such as liquid nitrogen.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Significance and Use
4.1 The proper design of low-temperature storage facilities
2. Referenced Documents
ensuresthatsensitivebiologicalmaterialsaremaintainedunder
2.1 ASTM Standards:
conditions providing maximum storage stability.
E1342PracticeforPreservationbyFreezing,Freeze-Drying,
4.2 Properlydesignedandoperatedlow-temperaturestorage
and Low Temperature Maintenance of Bacteria, Fungi,
facilities ensure that the handling of sensitive biological
Protista,Viruses,GeneticElements,andAnimalandPlant
materials at low temperatures does not compromise stability
(see Guide E1565).
This guide is under the jurisdiction ofASTM Committee E55 on Manufacture
4.3 Properly designed low-temperature storage facilities
of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.04
ensure that adequate safeguards are provided to prevent un-
on General Biopharmaceutical Standards.
toward events from compromising the stability of sensitive
Current edition approved Nov. 1, 2006. Published January 2007. Originally
approved in 1993. Last previous edition approved in 2000 as E1564–00. DOI:
biological materials.
10.1520/E1564-00R06.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
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E1564 − 00 (2006)
5. Procedure sealed completely. Vials may be examined for leaks by
immersing them in an aqueous methylene blue (0.05%)
5.1 Low-Temperature Mechanical Freezers:
solution at 4°C.
5.1.1 Ensure that adequate dedicated electrical power is
5.2.6 Storing material in the vapor phase of the liquid
available to support the number of mechanical freezers re-
nitrogen freezer requires validating the unit to ensure that
quired in the facility.
sufficient liquid nitrogen is kept in the bottom of the unit to
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
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