1、Designation:E156400(Reapproved 2019)Standard Guide forDesign and Maintenance of Low-Temperature StorageFacilities for Maintaining Cryopreserved BiologicalMaterials1This standard is issued under the fixed designation E1564;the number immediately following the designation indicates the year oforiginal
2、 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.INTRODUCTIONStorage facilities for maintaining cryopreserved biological materials are
3、 generally comprised of twotypes of low-temperature systems:(1)freezers that are cooled by mechanical refrigeration and(2)freezers that are cooled passively with liquid nitrogen.Either system can be used for the storage offrozen biological materials as long as it meets the criteria specific to the m
4、aterial being stored forensuring stability.Each system has its own unique handling requirements.1.Scope1.1 This guide covers recommended procedures for devel-oping and maintaining low-temperature storage facilities forfreezers with mechanical refrigeration.1.2 This guide covers recommended procedure
5、s for devel-oping and maintaining low-temperature storage facilities forfreezers cooled with liquid nitrogen.1.3 This guide does not cover practices for preservation byfreezing which are covered in Practice E1342.1.4 The values stated in SI units are to be regarded asstandard.No other units of measu
6、rement 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,health,and environmental practices and deter-mine the applicability of regu
7、latory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Or
8、ganization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2E1342 Practice for Preservation by Freezing,Freeze-Drying,and Low Temperature Maintenance of Bacteria,Fungi,Protista,Viruses,Genetic Elements,and Animal and PlantTissues(Withdrawn 2011)3E1565 Guide for Inve
9、ntory Control and Handling of Bio-logical Material Maintained at Low TemperaturesE1566 Guide for Handling Hazardous Biological Materialsin Liquid Nitrogen3.Terminology3.1 Definitions:3.1.1 cryogenic temperatures,ntemperatures below orequal to 100C.3.1.2 mechanical refrigeration,na refrigeration syst
10、em inwhich cooling is provided by mechanical means such as acompressor.3.1.3 passive refrigeration,na refrigeration system inwhich cooling is provided by a refrigerant such as liquidnitrogen.4.Significance and Use4.1 The proper design of low-temperature storage facilitiesensures that sensitive biolo
11、gical materials are maintained underconditions providing maximum storage stability.1This 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.
12、Current edition approved Feb.1,2019.Published March 2019.Originallyapproved in 1993.Last previous edition approved in 2014 as E1564 00(2014).DOI:10.1520/E1564-00R19.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book o
13、f ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The 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 StatesThis inte
14、rnational standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Commi
15、ttee.1 4.2 Properly designed and operated low-temperature storagefacilities ensure that the handling of sensitive biologicalmaterials at low temperatures does not compromise stability(see Guide E1565).4.3 Properly designed low-temperature storage facilitiesensure that adequate safeguards are provide
16、d to prevent un-toward events from compromising the stability of sensitivebiological materials.5.Procedure5.1 Low-Temperature Mechanical Freezers:5.1.1 Ensure that adequate dedicated electrical power isavailable to support the number of mechanical freezers re-quired in the facility.5.1.2 Provide for emergency electrical power to maintainthe freezers when commercial power disruptions occur.5.1.3 Place the freezers in a temperature-and humidity-controlled area with adequate ventilation.5.1.4 Obtai