ASTM E1565-00(2014)
(Guide)Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
SIGNIFICANCE AND USE
4.1 The proper handling of material stored at low temperatures ensures that the stability of sensitive biological materials is not comprised.
4.2 Properly designed inventory control systems ensure the maximum use of freezer space, that all material can be located easily, and that any item is retrieved easily without compromising the stability of other items in the freezer.
4.3 Properly designed safety and security procedures ensure that material stored at low temperatures is not comprised during storage, and that if material is lost due to freezer failure or operational problems, replacement material is available (see Guide E1566).
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 recommendations 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 Guide 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 standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, 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.
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Designation: E1565 − 00 (Reapproved 2014)
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 (´) 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 2. Referenced Documents
1.1 This guide covers recommended procedures for han- 2.1 ASTM Standards:
dling material stored at low temperatures in mechanical freez-
E1342PracticeforPreservationbyFreezing,Freeze-Drying,
ers and liquid nitrogen freezers. and Low Temperature Maintenance of Bacteria, Fungi,
Protista,Viruses, Genetic Elements, andAnimal and Plant
1.2 This guide covers recommendations for implementing
Tissues (Withdrawn 2011)
procedures for ensuring adequate inventory control.
E1564 Guide for Design and Maintenance of Low-
1.3 This guide covers recommendations for implementing
Temperature Storage Facilities for Maintaining Cryopre-
procedures for safeguarding material stored at low tempera-
served Biological Materials
tures.
E1566Guide for Handling Hazardous Biological Materials
in Liquid Nitrogen
1.4 This guide does not cover the development or mainte-
nance of equipment and facilities for low-temperature storage
which are covered in Guide E1564. 3. Terminology
1.5 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.
1.6 The values stated in SI units are to be regarded as
3.1.2 liquid nitrogen freezers—freezers that operate by a
standard. No other units of measurement are included in this
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 concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- eration system in which cooling is provided by mechanical
means such as a compressor.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1 2
This guide is under the jurisdiction ofASTM Committee E55 on Manufacture For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee E55.04 on General Biopharmaceutical Standards. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Dec. 1, 2014. Published January 2015. Originally the ASTM website.
approved in 1993. Last previous edition approved in 2006 as E1565–00 (2006). The last approved version of this historical standard is referenced on
DOI: 10.1520/E1565-00R14. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1565 − 00 (2014)
4. Significance and Use 5.1.7 When boxes are used for storage in liquid nitrogen,
place a small number of working vials in an easily accessible
4.1 The proper handling of material stored at low tempera-
location, leaving the majority of vials untouched in the colder
tures ensures that the stability of sensitive biological materials
portion of the freezer.
is not comprised.
5.1.8 Store seed material in a separate freezer to ensure that
4.2 Properly designed inventory control systems ensure the
itisnotcompromisedbyrepeatedhandlingduringtheretrieval
maximum use of freezer space, that all material can be located
of working stocks.
easily, and that any item is retrieved easily without compro-
5.2 Safekeeping:
mising the stability of other items in the freezer.
5.2.1 Store some vials of working stock or seed material, or
4.3 Properlydesignedsafetyandsecurityproceduresensure
both, separate from the main lot of material for safekeeping.
that material stored at low temperatures is not comprised
5.2.2 Maintain safekeeping material in a separate freezer
during storage, and that if material is lost due to freezer failure
and in a remote location, if possible.
or operational problems, replacement material is available (see
5.2.3 Do not
...
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: E1565 − 00 (Reapproved 2006) E1565 − 00 (Reapproved 2014)
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) 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
procedures and the development of adequate safeguards. Because of the sensitivity of many biological
materials, care must be taken that critical temperatures are not compromised during retrieval and other
activities involving handling of the material. Safeguards must also be established to ensure both
adequate temperatures at all times during storage and that inventory control provides a mechanism for
ease of retrieval.
1. 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 recommendations 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 Guide 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. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, 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)
E1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological
Materials
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.
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, 2006. Published December 2006.
Current edition approved Dec. 1, 2014. Published January 2015. Originally approved in 1993. Last previous edition approved in 20002006 as E1565 – 00.E1565 – 00
(2006). DOI: 10.1520/E1565-00R06.10.1520/E1565-00R14.
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
E1565 − 00 (2014)
3.1.2 liquid nitrogen freezers—freezers that operate by a refrigeration system in which cooling is provided by a refrigerant such
as liquid nitrogen.
3.1.3 mechanical freezers—freezers that operate by a refrigeration system in which cooling is provided by mechanical means
such as a compressor.
4. Significance and Use
4.1 The proper handling of material stored at low temperatures ensures that the stability of sensitive biological materials is not
comprised.
4.2 Properly designed inventory control systems ensure the maximum use of freezer space, that all material can be located
easily, and that any item is retrieved easily without compromising the stability of other items in the freezer.
4.3 Properly designed safety and security procedures ensure that material stored at low temperatures is not comprised during
storage, and that if material is lost due to freezer failure or operational problems, replacement material is available (see Guide
E1566).
5. Procedures
5.1 Inventory Control and Handling:
5.1.1 Prior to storing frozen material, set up a system of labeling and tracking vials that ensures proper identification, location,
and date of preparation of the vials. The label should include at least an identification code and lot number for the material.
5.1.2 Set aside a portion of the initial lot of the material designated as seed or master stoc
...
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