ASTM_E_1566_-_00_2014.pdf

Designation:E156600(Reapproved 2014)Standard Guide forHandling Hazardous Biological Materials in Liquid Nitrogen1This standard is issued under the fixed designation E1566;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONHazardous biological materials maintained at liquid nitrogen temperatures require special handlingand storage procedures.The penetration of vials by liquid nitrogen during storage can result incontamination of the nitrogen itself2or contamination of personnel resulting from improperly sealedvials exploding.3,4Ensuring safe storage conditions and taking precautions during the retrieval ofcultures from liquid nitrogen can help reduce the potential hazards.To avoid the penetration of vialsby liquid nitrogen and resulting hazards,they should be filled to a point that minimizes the air spacein the vial,and they shall be sealed completely.Vials may be examined for leaks by immersing themin an aqueous methylene blue(0.05%)solution at 4C.1.Scope1.1 This guide covers recommended procedures for main-taining and handling hazardous biological materials at liquidnitrogen temperatures.1.2 This guide covers the safety precautions recommendedwhen handling material stored in liquid nitrogen.1.3 This guide does not cover the maintenance and handlingof hazardous biological materials maintained at cryogenictemperatures in systems other than liquid nitrogen.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:5E1342 Practice for Preservation by Freezing,Freeze-Drying,and Low Temperature Maintenance of Bacteria,Fungi,Protista,Viruses,Genetic Elements,and Animal and PlantTissues(Withdrawn 2011)63.Terminology3.1 Definitions:3.1.1 cryogenic temperaturestemperatures below or equalto 100C.3.1.2 hazardous biological materialsliving biologicalmaterials,and products derived therefrom,that pose a potentialthreat to human health.3.1.3 liquid nitrogen storagestorage directly in liquidnitrogen or in the vapor phase above liquid nitrogen.4.Significance and Use4.1 This guide is intended for use by individuals maintain-ing and handling hazardous biological material in liquidnitrogen freezers.4.2 This guide does not cover all aspects of every situationthat may be encountered in maintaining hazardous biological1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical and Biopharmaceutical Products and is the direct responsibility ofSubcommittee E55.04 on General Biopharmaceutical Standards.Current edition approved Dec.1,2014.Published January 2015.Originallyapproved in 1993.Last previous edition approved in 2006 as E1566 00(2006).DOI:10.1520/E1566-00R14.2Shafer,T.W.,Everett,J.,Silver,G.H.,and Came,P.E.,“Biohazard:Virus-Contaminated Liquid Nitrogen,”Science,Vol 191,1976,pp.2426.3Simione,F.P.,Jr.,Daggett,P.-M.,McGrath,M.S.,and Alexander,M.T.,“TheUse of Plastic Ampoules for Freeze Preservation of Microorganisms,”Cryobiology,Vol 14,1977,pp.500502.4Grieff,D.,Melton,H.,and Rowe,T.W.,“On the Sealing of Gas-Filled GlassAmpoules,”Cryobiology,Vol 12,1975,pp.114.5For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.6The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 material in liquid nitrogen;each situation must therefore beassessed individually using these guidelines.4.3 This guide is not intended for use with systems otherthan liquid nitrogen storage.4.4 This guide does not cover practices for preservation byfreezing which are covered in Practice E1342.5.Procedures5.1 All Liquid Nitrogen Freezers:5.1.1 Liquid nitrogen freezers vary from all-liquid storage,to liquid and vapor storage,to all-vapor storage.Freezers withall-liquid storage present the greatest hazard,and freezers withall-vapor storage present the least hazard.The type of systemin use should be assessed before attempting to apply theseguidelines.5.1.2 When working in freezers with all liquid storage,theoperator shall work in or near the liquid nitrogen wheninserting and retrieving material.5.1.3 Freezers with both liquid and vapor storage reduce theproximity of the operator to the liquid nit