ASTM E1566-00(2014)

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: E1566 − 00 (Reapproved 2006) E1566 − 00 (Reapproved 2014)
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
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. 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 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)
3. Terminology
3.1 Definitions:
3.1.1 cryogenic temperatures—temperatures below or equal to −100°C.
3.1.2 hazardous biological materials—living biological materials, and products derived therefrom, that pose a potential threat
to human health.
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 E1566 – 00.E1566 – 00
(2006). DOI: 10.1520/E1566-00R06.10.1520/E1566-00R14.
Shafer, T.W., Everett, J., Silver, G.H., and Came, P.E., “Biohazard: Virus-Contaminated Liquid Nitrogen,” Science, Vol 191, 1976, pp. 24–26.
Simione, F.P., Jr., Daggett, P.-M., McGrath, M.S., and Alexander, M.T., “The Use of Plastic Ampoules for Freeze Preservation of Microorganisms,” Cryobiology, Vol
14, 1977, pp. 500–502.
Grieff, D., Melton, H., and Rowe, T. W., “On the Sealing of Gas-Filled Glass Ampoules,” Cryobiology, Vol 12, 1975, pp. 1–14.
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
E1566 − 00 (2014)
3.1.3 liquid nitrogen storage—storage directly in liquid nitrogen or in the vapor phase above liquid nitrogen.
4. 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 oth
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