1、Designation: E1565 00 (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 c
2、ase 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.INTRODUCTIONThe stability of biological material stored at low temperatures is dependent on proper ha
3、ndlingprocedures 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 ensur
4、e bothadequate 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 cove
5、rs recommendations 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 l
6、ow-temperature 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
7、 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
8、Standards:2E1342 Practice for Preservation by Freezing, Freeze-Drying,and Low Temperature Maintenance of Bacteria, Fungi,Protista, Viruses, Genetic Elements, andAnimal and PlantTissues (Withdrawn 2011)3E1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryop
9、re-served Biological MaterialsE1566 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 provide
10、d by a refrig-erant such 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 Products and is the d
11、irect responsibility of Subcommittee E55.04on 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 AS
12、TM 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 Intern
13、ational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14. 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 sys
14、tems ensure themaximum 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 comp
15、risedduring storage, and 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 prope
16、r identification,location, and 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
17、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. The best inventory system for largeliquid nitrogen units is one in
18、 which vials are attached to metalcanes in a vertical array. Boxes can be used for smaller units.Designate each freezer, box or cane, and location within a box,using a unique combination of letters and numbers, and thenassign each lot of material a location code.5.1.4 Maintaining inventory records o
19、n a computer simpli-fies access and allows cross referencing locations and vial labelinformation. The inventory system should be designed to allowvacated locations to be re-stocked with new material in order tomaximize storage space.5.1.5 The inventory system should be designed to minimizehandling d
20、uring stocking and retrieval operations. This will notonly reduce worker exposure to cold temperatures, but it willalso minimize the exposure of other materials when retrievinga particular item.5.1.6 The storage of vials on canes ensures that only the vialbeing retrieved is exposed to warmer tempera
21、tures. Canes alsoprovide an inventory system that allows easy access to allmaterial.5.1.7 When boxes are used for storage in liquid nitrogen,place a small number of working vials in an easily accessiblelocation, leaving the majority of vials untouched in the colderportion of the freezer.5.1.8 Store
22、seed material in a separate freezer to ensure thatit is not compromised by repeated handling during the retrievalof working stocks.5.2 Safekeeping:5.2.1 Store some vials of working stock or seed material, orboth, separate from the main lot of material for safekeeping.5.2.2 Maintain safekeeping mater
23、ial in a separate freezerand in a remote location, if possible.5.2.3 Do not rely on seed material alone for safekeeping, asit is irreplaceable. Material designated for safekeeping shouldbe replaceable and should not be considered any less vulner-able than the working stock it is backing up.5.3 Safet
24、y:5.3.1 Precautions shall be taken to provide personnel pro-tection from the extreme cold encountered at cryogenic tem-peratures. Extremities shall be protected at all times usinggloves. Thin nylon gloves provide some protection whenhandling ampules, but insulated gloves designed for working atcryog
25、enic temperatures should be used when possible.5.3.2 When vials are stored directly in the liquid, theyshould be filled to a point that minimizes the air space in thevial, and they shall be sealed completely. Vials may beexamined for leaks by immersing them in an aqueous methyl-ene blue (0.05 %) sol
26、ution at 4C.5.3.2.1 Because of the potential for exploding vials whenretrieving from liquid nitrogen, precautions shall be taken toprotect the operator from glass shards. Heavy gloves, labora-tory coat, and face shield should be mandatory wheneverretrieving vials from liquid nitrogen. In addition, g
27、lass vialsshould be placed inside a metal canister before removing thevial to warmer temperatures.5.3.3 Nitrogen will displace oxygen in confined areas withpoor ventilation, especially during fill operations. Care shall betaken to ensure the proper ventilation of all areas housingliquid nitrogen fre
28、ezers, and an oxygen monitor with alarmshould be installed in the area.5.3.4 Hazardous biological materials should not be main-tained directly in liquid nitrogen, because of the potential forleaking and exploding vials (see Guide E1566).5.3.5 When freezers are no longer used, they should bedecontami
29、nated after warming before removal or reuse.6. Keywords6.1 biological material; inventory control; low temperaturesE1565 00 (2014)2ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard
30、are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif no
31、t revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which
32、you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,Unit
33、ed States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 00 (2014)3
