ASTM E1565-00(2006)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E1565 − 00(Reapproved 2006)
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Tissues (Withdrawn 2011)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
3. Terminology
which are covered in Guide E1564.
3.1 Definitions:
1.5 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.
1.6 The values stated in SI units are to be regarded as the
3.1.2 liquid nitrogen freezers—freezers that operate by a
standard.
refrigeration system in which cooling is provided by a refrig-
1.7 This standard does not purport to address all of the
erant such as liquid nitrogen.
safety concerns, if any, associated with its use. It is the
3.1.3 mechanical freezers—freezersthatoperatebyarefrig-
responsibility of the user of this standard to establish appro-
eration system in which cooling is provided by mechanical
priate safety and health practices and determine the applica-
means such as a compressor.
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
of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.04 contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
on General Biopharmaceutical Standards. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 1, 2006. Published December 2006. the ASTM website.
Originally approved in 1993. Last previous edition approved in 2000 as The last approved version of this historical standard is referenced on
E1565–00. DOI: 10.1520/E1565-00R06. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1565 − 00 (2006)
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.
5.2.2 Maintain safekeeping material in a separate freezer
that material stored at low temperatures is not comprised
during storage, and that if material is lost due to freezer failure and in a remote location, if possible.
5.2.3 Do not rely on seed material alone for safekeeping, as
or oper
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