ASTM E1566-00(2006)

Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

SIGNIFICANCE AND USE
This guide is intended for use by individuals maintaining and handling hazardous biological material in liquid nitrogen freezers.
This guide does not cover all aspects of every situation that may be encountered in maintaining hazardous biological material in liquid nitrogen; each situation must therefore be assessed individually using these guidelines.
This guide is not intended for use with systems other than liquid nitrogen storage.
This guide does not cover practices for preservation by freezing which are covered in Practice E 1342.
SCOPE
1.1 This guide covers recommended procedures for maintaining and handling hazardous biological materials at liquid nitrogen temperatures.
1.2 This guide covers the safety precautions recommended when handling material stored in liquid nitrogen.
1.3 This guide does not cover the maintenance and handling of hazardous biological materials maintained at cryogenic temperatures in systems other than liquid nitrogen.
1.4 The values stated in SI units are to be regarded as the standard.
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.

General Information

• Status: Historical
• Publication Date: 31-Oct-2006
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 27.200 - Refrigerating technology
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.04 - General Biopharmaceutical Standards

Relations

• Replaces: ASTM E1566-00 - Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
• Effective Date: 01-Nov-2006
• Replaced By: ASTM E1566-00(2014) - Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
• Effective Date: 01-Dec-2014
• Referred By: ASTM E2363-23 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
• Effective Date: 01-Nov-2006
• Referred By: ASTM E1565-00(2019) - Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
• Effective Date: 01-Nov-2006
• Referred By: ASTM E1564-00(2019) - Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
• Effective Date: 01-Nov-2006

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: E1566 − 00(Reapproved 2006)
Standard Guide for
Handling Hazardous Biological Materials in Liquid Nitrogen
This standard is issued under the fixed designation E1566; 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
Hazardous biological materials maintained at liquid nitrogen temperatures require special handling
and storage procedures. The penetration of vials by liquid nitrogen during storage can result in
contamination of the nitrogen itself or contamination of personnel resulting from improperly sealed
3,4
vials exploding. Ensuring safe storage conditions and taking precautions during the retrieval of
cultures from liquid nitrogen can help reduce the potential hazards. To avoid the penetration of vials
by liquid nitrogen and resulting hazards, they should be filled to a point that minimizes the air space
in the vial, and they shall be sealed completely. Vials may be examined for leaks by immersing them
in an aqueous methylene blue (0.05%) solution at 4°C.
1. Scope 2. Referenced Documents
1.1 This guide covers recommended procedures for main- 2.1 ASTM Standards:
taining and handling hazardous biological materials at liquid E1342PracticeforPreservationbyFreezing,Freeze-Drying,
nitrogen temperatures. and Low Temperature Maintenance of Bacteria, Fungi,
Protista,Viruses, Genetic Elements, andAnimal and Plant
1.2 This guide covers the safety precautions recommended
Tissues (Withdrawn 2011)
when handling material stored in liquid nitrogen.
3. Terminology
1.3 Thisguidedoesnotcoverthemaintenanceandhandling
of hazardous biological materials maintained at cryogenic
3.1 Definitions:
temperatures in systems other than liquid nitrogen.
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 the
standard.
3.1.2 hazardous biological materials—living biological
materials,andproductsderivedtherefrom,thatposeapotential
1.5 This standard does not purport to address all of the
threat to human health.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.1.3 liquid nitrogen storage—storage directly in liquid
priate safety and health practices and determine the applica-
nitrogen or in the vapor phase above liquid nitrogen.
bility of regulatory limitations prior to use.
4. Significance and Use
4.1 This guide is intended for use by individuals maintain-
This guide is under the jurisdiction ofASTM Committee E55 on Manufacture
ing and handling hazardous biological material in liquid
of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.04
nitrogen freezers.
on General Biopharmaceutical Standards.
Current edition approved Nov. 1, 2006. Published December 2006.
4.2 This guide does not cover all aspects of every situation
Originally approved in 1993. Last previous edition approved in 2000 as
that may be encountered in maintaining hazardous biological
E1566–00. DOI: 10.1520/E1566-00R06.
Shafer, T.W., Everett, J., Silver, G.H., and Came, P.E., “Biohazard: Virus-
Contaminated Liquid Nitrogen,” Science, Vol 191, 1976, pp. 24–26. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Simione, F.P., Jr., Daggett, P.-M., McGrath, M.S., and Alexander, M.T., “The contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Use of PlasticAmpoules for Freeze Preservation of Microorganisms,” Cryobiology, Standards volume information, refer to the standard’s Document Summary page on
Vol 14, 1977, pp. 500–502. the ASTM website.
4 6
Grieff, D., Melton, H., and Rowe, T. W., “On the Sealing of Gas-Filled Glass The last approved version of this historical standard is referenced on
Ampoules,” Cryobiology, Vol 12, 1975, pp. 1–14. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1566 − 00 (2006)
material in liquid nitrogen; each situation must therefore be 5.3 Liquid/Vapor Storage Freezers:
assessed individually using these guidelines.
5.3.1 Protective clothing should include a laboratory coat
and surgical gloves. A face shield should be worn when
4.3 This guide is not intended for use with sys
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