ASTM E1564-00(2014)
(Guide)Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
SIGNIFICANCE AND USE
4.1 The proper design of low-temperature storage facilities ensures that sensitive biological materials are maintained under conditions providing maximum storage stability.
4.2 Properly designed and operated low-temperature storage facilities ensure that the handling of sensitive biological materials at low temperatures does not compromise stability (see Guide E1565).
4.3 Properly designed low-temperature storage facilities ensure that adequate safeguards are provided to prevent untoward events from compromising the stability of sensitive biological materials.
SCOPE
1.1 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers with mechanical refrigeration.
1.2 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers cooled with liquid nitrogen.
1.3 This guide does not cover practices for preservation by freezing which are covered in Practice E1342.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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
Relations
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E1564 − 00 (Reapproved 2014)
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 Protista,Viruses,GeneticElements,andAnimalandPlant
Tissues (Withdrawn 2011)
1.1 This guide covers recommended procedures for devel-
E1565Guide for Inventory Control and Handling of Bio-
oping and maintaining low-temperature storage facilities for
logical Material Maintained at Low Temperatures
freezers with mechanical refrigeration.
E1566Guide for Handling Hazardous Biological Materials
1.2 This guide covers recommended procedures for devel-
in Liquid Nitrogen
oping and maintaining low-temperature storage facilities for
freezers cooled with liquid nitrogen. 3. Terminology
1.3 This guide does not cover practices for preservation by
3.1 Definitions:
freezing which are covered in Practice E1342. 3.1.1 cryogenic temperatures—temperatures below or equal
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. No other units of measurement are included in this
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
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
2. Referenced Documents
ensuresthatsensitivebiologicalmaterialsaremaintainedunder
conditions providing maximum storage stability.
2.1 ASTM Standards:
E1342PracticeforPreservationbyFreezing,Freeze-Drying,
4.2 Properlydesignedandoperatedlow-temperaturestorage
and Low Temperature Maintenance of Bacteria, Fungi,
facilities ensure that the handling of sensitive biological
materials at low temperatures does not compromise stability
(see Guide E1565).
This guide is under the jurisdiction ofASTM Committee E55 on Manufacture
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof
4.3 Properly designed low-temperature storage facilities
Subcommittee E55.04 on General Biopharmaceutical Standards.
ensure that adequate safeguards are provided to prevent un-
Current edition approved Dec. 1, 2014. Published January 2015. Originally
toward events from compromising the stability of sensitive
approved in 1993. Last previous edition approved in 2006 as E1564–00 (2006).
biological materials.
DOI: 10.1520/E1564-00R14.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1564 − 00 (2014)
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
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1564 − 00 (Reapproved 2006) E1564 − 00 (Reapproved 2014)
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
1.1 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers
with mechanical refrigeration.
1.2 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers
cooled with liquid nitrogen.
1.3 This guide does not cover practices for preservation by freezing which are covered in Practice E1342.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
2. Referenced Documents
2.1 ASTM Standards:
E1342 Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria, Fungi, Protista,
Viruses, Genetic Elements, and Animal and Plant Tissues (Withdrawn 2011)
E1565 Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
E1566 Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
3. Terminology
3.1 Definitions:
3.1.1 cryogenic temperatures—temperatures below or equal to −100°C.
3.1.2 mechanical refrigeration—a refrigeration system in which cooling is provided by mechanical means such as a compressor.
3.1.3 passive refrigeration—a refrigeration system in which cooling is provided by a refrigerant such as liquid nitrogen.
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.04 on
General Biopharmaceutical Standards.
Current edition approved Nov. 1, 2006Dec. 1, 2014. Published January 2007 January 2015. Originally approved in 1993. Last previous edition approved in 20002006 as
E1564 – 00.E1564 – 00 (2006). DOI: 10.1520/E1564-00R06.10.1520/E1564-00R14.
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 ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1564 − 00 (2014)
4. Significance and Use
4.1 The proper design of low-temperature storage facilities ensures that sensitive biological materials are maintained under
conditions providing maximum storage stability.
4.2 Properly designed and operated low-temperature storage facilities ensure that the handling of sensitive biological materials
at low temperatures does not compromise stability (see Guide E1565).
4.3 Properly designed low-temperature storage facilities ensure that adequate safeguards are provided to prevent untoward
events from compromising the stability of sensitive biological materials.
5. Procedure
5.1 Low-Temperature Mechanical Freezers:
5.1.1 Ensure that adequate dedicated electrical power is available to support the number of mechanical freezers required in the
facility.
5.1.2 Provide for emergency electrical power to maintain the freezers when commercial power disruptions occur.
5.1.3 Place the freezers in a temperature- and humidity-controlled area with adequate ventilation.
5.1.4 Obtain a source of service support for the refrigeration systems that is reliable and can respond to mechanical problems
rapidly. An alternative source should also be available.
5.1.5 When selecting mechanical freezers, be sure that the lowest attainable temperature of the unit is cold enough to ensure
the stability of the biological material to be stored in them.
5.1.6 The temperature of mechanical freezers shall be monitored daily to ensure that consistently low temperatures are
maintained. Most units have temperature-sensing devices built in that allow both control and monitoring of the freezer temperature.
These internal units can malfunction and fool alarm systems. A temperature detecting probe should therefore be inserted into each
mechanical freezer, and the temperature should be read manually, or recorded automatically, on a remote sensing device.
5.1.7 The temperature monitoring device shall be calibrated annually against a standard traceable to the National Institute for
Standards and Technology (NIST).
5.2 Liquid Nitrogen Freezers:
5.2.1 Liquid nitrogen freezers are passive cooling systems that use liquid nitrogen as the refrigerant. A reliable source of liquid
nitrogen shall be available to maintain liquid nitrogen freezers.
5.2.2 Liquid nitrogen freezers provide the greatest assurance of long-term stability because of the low temperatures that can be
attained (−150 to −196°C).
5.2.3 Choose a liquid nitrogen freezer that is compatible w
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.