ASTM E1564-00(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: E1564 − 00 (Reapproved 2019)
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Storage facilities for maintaining cryopreserved biological materials are generally comprised of two
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 2. Referenced Documents
2.1 ASTM Standards:
1.1 This guide covers recommended procedures for devel-
E1342 Practice for Preservation by Freezing, Freeze-Drying,
oping and maintaining low-temperature storage facilities for
and Low Temperature Maintenance of Bacteria, Fungi,
freezers with mechanical refrigeration.
Protista, Viruses, Genetic Elements, and Animal and Plant
1.2 This guide covers recommended procedures for devel-
Tissues (Withdrawn 2011)
oping and maintaining low-temperature storage facilities for
E1565 Guide for Inventory Control and Handling of Bio-
freezers cooled with liquid nitrogen.
logical Material Maintained at Low Temperatures
E1566 Guide for Handling Hazardous Biological Materials
1.3 This guide does not cover practices for preservation by
in Liquid Nitrogen
freezing which are covered in Practice E1342.
3. Terminology
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3.1 Definitions:
standard.
3.1.1 cryogenic temperatures, n—temperatures below or
equal to −100°C.
1.5 This standard does not purport to address all of the
3.1.2 mechanical refrigeration, n—a refrigeration system in
safety concerns, if any, associated with its use. It is the
which cooling is provided by mechanical means such as a
responsibility of the user of this standard to establish appro-
compressor.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. 3.1.3 passive refrigeration, n—a refrigeration system in
which cooling is provided by a refrigerant such as liquid
1.6 This international standard was developed in accor-
nitrogen.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
4. Significance and Use
Development of International Standards, Guides and Recom-
4.1 The proper design of low-temperature storage facilities
mendations issued by the World Trade Organization Technical
ensures that sensitive biological materials are maintained under
Barriers to Trade (TBT) Committee.
conditions providing maximum storage stability.
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 E55.11 on Process Design. 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 E1564 – 00 (2014). The last approved version of this historical standard is referenced on
DOI: 10.1520/E1564-00R19. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1564 − 00 (2019)
4.2 Properly designed and operated low-temperature storage liquid levels and to allow automatic and manual filling. Manual
facilities ensure that the handling of sensitive biological dipstick measurements should also be performed to ensure that
materials at low temperatures does not compromise stability the monitoring equipment is working properly.
(see Guide E1565). 5.2.5 If possible, do not store vials directly in the liquid
phase since improperly sealed vials can leak, leading to
4.3 Properly designed low-temperature storage facilities
potential contamination and exploding vials upon retrieval.
ensure that adequate safeguards are provided to prevent un-
Maintain the vials in the vapor phase above the liquid. When
toward events from compromising the stability of sensitive
vials are stored directly in the liquid, they should be filled to a
biological materials.
point that minimizes the air space in the vial, and they shall be
sealed completely. Vials may be examined for leaks by
5. Procedure
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-
temperature at the top with the freezer open, and raise the level
controlled area with adequate ventilation.
of the liquid nitrogen until the temperature remains at or
5.1.4 Obtain a source of service support for the refrigeration 5
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 nitrog
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