ASTM E1566-00(2019)

Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

SIGNIFICANCE AND USE
4.1 This guide is intended for use by individuals maintaining and handling hazardous biological material in liquid nitrogen freezers.  
4.2 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.  
4.3 This guide is not intended for use with systems other than liquid nitrogen storage.  
4.4 This guide does not cover practices for preservation by freezing which are covered in Practice E1342.
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 standard. No other units of measurement are included in this standard.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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.

General Information

• Status: Published
• Publication Date: 31-Jan-2019
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 27.200 - Refrigerating technology
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.13 - Process Evaluation and Control

Relations

• Refers: ASTM E1342-97(2002) - Standard 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and Low Temperature Maintenance of Bacteria, Fungi, Protista, Viruses, Genetic Elements, and Animal and Plant Tissues (Withdrawn 2011)
• Effective Date: 10-Oct-1997
• Refers: ASTM E1342-97 - Standard Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria, Fungi, Protista, Viruses, Genetic Elements, and Animal and Plant Tissues
• Effective Date: 01-Jan-1990

Standards Content (Sample)

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: E1566 − 00 (Reapproved 2019)
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. A number 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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This guide covers recommended procedures for main-
Barriers to Trade (TBT) Committee.
taining and handling hazardous biological materials at liquid
nitrogen temperatures.
2. Referenced Documents
1.2 This guide covers the safety precautions recommended
2.1 ASTM Standards:
when handling material stored in liquid nitrogen.
E1342 Practice for Preservation by Freezing, Freeze-Drying,
1.3 This guide does not cover the maintenance and handling
and Low Temperature Maintenance of Bacteria, Fungi,
of hazardous biological materials maintained at cryogenic
Protista, Viruses, Genetic Elements, and Animal and Plant
temperatures in systems other than liquid nitrogen.
Tissues (Withdrawn 2011)
1.4 The values stated in SI units are to be regarded as
3. Terminology
standard. No other units of measurement are included in this
standard.
3.1 Definitions:
3.1.1 cryogenic temperatures, n—temperatures below or
1.5 This standard does not purport to address all of the
equal to −100°C.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.1.2 hazardous biological materials, n—living biological
priate safety, health, and environmental practices and deter-
materials, and products derived therefrom, that pose a potential
mine the applicability of regulatory limitations prior to use.
threat to human health.
1.6 This international standard was developed in accor-
3.1.3 liquid nitrogen storage, n—storage directly in liquid
dance with internationally recognized principles on standard-
nitrogen or in the vapor phase above liquid nitrogen.
ization established in the Decision on Principles for the
4. Significance and Use
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
4.1 This guide is intended for use by individuals maintain-
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
ing and handling hazardous biological material in liquid
Subcommittee E55.13 on Process Evaluation and Control.
Current edition approved Feb. 1, 2019. Published March 2019. Originally
nitrogen freezers.
approved in 1993. Last previous edition approved in 2014 as E1566 – 00 (2014).
DOI: 10.1520/E1566-00R19.
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 Plastic Ampoules 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.
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E1566 − 00 (2019)
4.2 This guide does not cover all aspects of every situation 5.2.7 Immediately place the retrieved material into dry ice
that may be encountered in maintaining hazardous biological for
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