1、Designation:E156500(Reapproved 2014)Standard Guide forInventory Control and Handling of Biological MaterialMaintained at Low Temperatures1This standard is issued under the fixed designation E1565;the number immediately following the designation indicates the year oforiginal adoption or,in the case o
2、f 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.INTRODUCTIONThe stability of biological material stored at low temperatures is dependent on proper handlingproc
3、edures and the development of adequate safeguards.Because of the sensitivity of many biologicalmaterials,care must be taken that critical temperatures are not compromised during retrieval and otheractivities involving handling of the material.Safeguards must also be established to ensure bothadequat
4、e temperatures at all times during storage and that inventory control provides a mechanism forease of retrieval.1.Scope1.1 This guide covers recommended procedures for han-dling material stored at low temperatures in mechanical freez-ers and liquid nitrogen freezers.1.2 This guide covers recommendat
5、ions for implementingprocedures for ensuring adequate inventory control.1.3 This guide covers recommendations for implementingprocedures for safeguarding material stored at low tempera-tures.1.4 This guide does not cover the development or mainte-nance of equipment and facilities for low-temperature
6、 storagewhich are covered in Guide E1564.1.5 This guide does not cover practices for preservation byfreezing which are covered in Practice E1342.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 This standard does not purpo
7、rt 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:2E1342 Pr
8、actice for Preservation by Freezing,Freeze-Drying,and Low Temperature Maintenance of Bacteria,Fungi,Protista,Viruses,Genetic Elements,and Animal and PlantTissues(Withdrawn 2011)3E1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopre-served Biological Mat
9、erialsE1566 Guide for Handling Hazardous Biological Materialsin Liquid Nitrogen3.Terminology3.1 Definitions:3.1.1 cryogenic temperaturestemperatures below or equalto 100C.3.1.2 liquid nitrogen freezersfreezers that operate by arefrigeration system in which cooling is provided by a refrig-erant such
10、as liquid nitrogen.3.1.3 mechanical freezersfreezers that operate by a refrig-eration system in which cooling is provided by mechanicalmeans such as a compressor.1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical and Biopharmaceutical Products and is the dire
11、ct 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 E1565 00(2006).DOI:10.1520/E1565-00R14.2For referenced ASTM standards,visit the ASTM website,
12、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 Bar
13、r Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Significance and Use4.1 The proper handling of material stored at low tempera-tures ensures that the stability of sensitive biological materialsis not comprised.4.2 Properly designed inventory control systems ensure themaxim
14、um use of freezer space,that all material can be locatedeasily,and that any item is retrieved easily without compro-mising the stability of other items in the freezer.4.3 Properly designed safety and security procedures ensurethat material stored at low temperatures is not comprisedduring storage,an
15、d that if material is lost due to freezer failureor operational problems,replacement material is available(seeGuide E1566).5.Procedures5.1 Inventory Control and Handling:5.1.1 Prior to storing frozen material,set up a system oflabeling and tracking vials that ensures proper identification,location,a
16、nd date of preparation of the vials.The label shouldinclude at least an identification code and lot number for thematerial.5.1.2 Set aside a portion of the initial lot of the materialdesignated as seed or master stock.The seed stock should besegregated from the working stocks,to be used for replenishingworking stocks.A seed stock system ensures that futureworking stocks are close in passage to the original material.5.1.3 Design an inventory system that allows easy accesswith simple locator codes
