ASTM_E_1564_-_00_2014.pdf

Designation:E156400(Reapproved 2014)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 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 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 material 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 procedures 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 measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety problems,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: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Low Temperature Maintenance of Bacteria,Fungi,Protista,Viruses,Genetic Elements,and Animal and PlantTissues(Withdrawn 2011)3E1565 Guide for Inventory Control and Handling of Bio-logical Material Maintained at Low TemperaturesE1566 Guide for Handling Hazardous Biological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 temperaturestemperatures below or equalto 100C.3.1.2 mechanical refrigerationa refrigeration system inwhich cooling is provided by mechanical means such as acompressor.3.1.3 passive refrigerationa refrigeration system in whichcooling is provided by a refrigerant such as liquid nitrogen.4.Significance and Use4.1 The proper design of low-temperature storage facilitiesensures that sensitive biological materials are maintained underconditions providing maximum storage stability.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 provided to prevent un-toward events from compromising the stability of sensitivebiological materials.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.Current edition approved Dec.1,2014.Published January 2015.Originallyapproved in 1993.Last previous edition approved in 2006 as E1564 00(2006).DOI:10.1520/E1564-00R14.2For 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.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 States1 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 Obtain a source of service support for the refrigerationsystems that is reliable and can respond to mechanical prob-lems rapidly.An alternative source should also be available.5.1.5 When selecting mechanical freezers,be sure that thelowest attainable temperature of the unit is cold enough toensure the stability of the biological material to be stored inthem.5.1.6 The temperature of mechanical freezers shall be moni-tored daily to ensure that consistently low temperatures aremaintained.Most units have temperature-sensing devices builtin that allow both control and monitoring of the freezertemperature.These internal units can malfunction and foolalar