ASTM E1565-2000(2006) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures《低温下保存的生物材料库存量控制与搬运的标准指南》.pdf

1、Designation: E 1565 00 (Reapproved 2006)Standard Guide forInventory Control and Handling of Biological MaterialMaintained at Low Temperatures1This standard is issued under the fixed designation E 1565; the number immediately following the designation indicates the year oforiginal adoption or, in the

2、 case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe stability of biological material stored at low temperatures is dependent on proper

3、 handlingprocedures 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 en

4、sure 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 c

5、overs 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 fo

6、r low-temperature storagewhich are covered in Guide E 1564.1.5 This guide does not cover practices for preservation byfreezing which are covered in Practice E 1342.1.6 The values stated in SI units are to be regarded as thestandard.1.7 This standard does not purport to address all of thesafety conce

7、rns, 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:2E 1342 Practice for Preservation by Free

8、zing, Freeze-Drying, and Low Temperature Maintenance of Bacteria,Fungi, Protista,Viruses, Genetic Elements, andAnimal andPlant TissuesE 1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopre-served Biological MaterialsE 1566 Guide for Handling Hazardous B

9、iological 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 as liquid nitrogen.3.1.3 mechanical freez

10、ersfreezers that operate by a refrig-eration system in which cooling is provided by mechanicalmeans such as a compressor.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 de

11、signed inventory control systems 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

12、low temperatures is not comprisedduring storage, and that if material is lost due to freezer failureor operational problems, replacement material is available (seeGuide E 1566).1This guide is under the jurisdiction ofASTM Committee E48 on Biotechnologyand is the direct responsibility of Subcommittee

13、 E48.02 on Characterization andIdentification of Biological Systems.Current edition approved Nov. 1, 2006. Published December 2006.Originally approved in 1993. Last previous edition approved in 2000 asE 1565 00.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cust

14、omer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5. Procedures5.1 Inventory Control

15、and Handling:5.1.1 Prior to storing frozen material, set up a system oflabeling and tracking vials that ensures proper 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 th

16、e 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

17、 that allows easy accesswith simple locator codes. The best inventory system for largeliquid nitrogen units is one in 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 combinat

18、ion of letters and numbers, and thenassign each lot of material a location code.5.1.4 Maintaining inventory records on 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 wi

19、th new material in order tomaximize storage space.5.1.5 The inventory system should be designed to minimizehandling during stocking and retrieval operations. This will notonly reduce worker exposure to cold temperatures, but it willalso minimize the exposure of other materials when retrievinga parti

20、cular item.5.1.6 The storage of vials on canes ensures that only the vialbeing retrieved is exposed to warmer temperatures. 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 a

21、n easily accessiblelocation, leaving the majority of vials untouched in the colderportion of the freezer.5.1.8 Store 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 st

22、ock or seed material, orboth, separate from the main lot of material for safekeeping.5.2.2 Maintain safekeeping material 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 sho

23、uldbe replaceable and should not be considered any less vulner-able than the working stock it is backing up.5.3 Safety: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 usingglov

24、es. Thin nylon gloves provide some protection whenhandling ampules, but insulated gloves designed for working atcryogenic 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 sh

25、all be sealed completely. Vials may beexamined for leaks by immersing them in an aqueous methyl-ene blue (0.05 %) solution 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

26、, labora-tory coat, and face shield should be mandatory wheneverretrieving vials from liquid nitrogen. In addition, glass 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, especiall

27、y during fill operations. Care shall betaken to ensure the proper ventilation of all areas housingliquid nitrogen freezers, 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 poten

28、tial forleaking and exploding vials (see Guide E 1566).5.3.5 When freezers are no longer used, they should bedecontaminated after warming before removal or reuse.6. Keywords6.1 biological material; inventory control; low temperaturesASTM International takes no position respecting the validity of any

29、 patent rights asserted in connection with any item mentionedin this standard. Users of this standard 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 revi

30、sion at any time by the responsible technical committee and must be reviewed every five years andif not 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

31、comments will receive careful consideration at a meeting of theresponsible technical committee, which 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 copyri

32、ghted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United 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).E 1565 00 (2006)2