1、Designation:F238311Standard Guide forAssessment of Adventitious Agents in Tissue EngineeredMedical Products(TEMPs)1This standard is issued under the fixed designation F2383;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of
2、last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is intended as a resource for individuals andorganizations involved in the production,delivery,and regula-tion o
3、f tissue engineered medical products(TEMPs).Thesafety from contamination by potentially infectious adventi-tious agents is important in the development of all TEMPs aswell as their components.This guide addresses how to assesssafety risks associated with adventitious agents and theirbyproducts.These
4、 agents currently include bacteria,fungi,mycoplasma,viruses,endotoxins,transmissible spongiformencephalopathies(TSEs),and parasitic organisms.This guidedoes not address TEMPs with live animal cells,tissues ororgans,or human cells,including stem cells,grown on anyanimal feeder cells.Also excluded is
5、patient follow-up testing.1.2 This guide does not apply to any medical products ofhuman origin regulated by the U.S.Food and Drug Adminis-tration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207,807 and 1271.This guide does apply to cellular therapiesregulated under the PHS(Public Health Service)
6、act.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 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 appr
7、o-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E1873 Guide for Detection of Nucleic Acid Sequences bythe Polymerase Chain Reaction TechniqueF2210 Guide for Processing Cells,Tissues,and Organs for
8、Use in Tissue Engineered Medical ProductsF2211 Classification for Tissue Engineered Medical Prod-ucts(TEMPs)F2312 Terminology Relating to Tissue Engineered MedicalProductsF2386 Guide for Preservation of Tissue Engineered MedicalProducts(TEMPs)2.2 ANSI/AAMI Standard:ST72 Bacterial EndotoxinTest Metho
9、dologies,RoutineMonitoring and Alternatives to Batch Testing32.3 Federal Regulations:49 CFR Animals and Animal Products21 CFR 210 Current Good Manufacturing Practice inManufacturing,Processing,Packing,or Holding of Drugs,General21 CFR 211 Current Good Manufacturing Practice for Fin-ished Pharmaceuti
10、cals21 CFR 610.12 General Biological Products StandardsSterility21 CFR 610.13(b)General Biological Products StandardsPurity Test for Pyrogenic Substances21 CFR 820 Quality System Regulation21 CFR 1270 Human Tissue Intended for Transplantation21 CFR 1271 Human Cells,Tissues,and Cellular andTissue-Bas
11、ed Products2.4 MDA Standard:Code of Practice for the Production of Human-DerivedTherapeutic Products52.5 U.S.Pharmacopeia Document:United States Pharmacopeia(USP),Edition XXIV(24)63.Terminology3.1 Definitions:1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Material
12、s and Devices and is the direct responsibility of SubcommitteeF04.45 on Adventitious Agents Safety.Current edition approved March 1,2011.Published March 2011.Originallyapproved in 2005.Last previous edition approved in 2005 as F2383 05.DOI:10.1520/F2383-11.2For referenced ASTM standards,visit the AS
13、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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/w
14、ww.ansi.org.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.5Available from Medicines and Healthcare Products Regulatory Agency(MHRA),Hannibal House,Elephant&Castle,London SE1 6TQ,U.K.6Availabl
15、e from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 adventitious agents,nunintentionally introduced mi-crobiological or other infectious contam
16、inant.In the produc-tion of TEMPs,these agents may be unintentionally introducedinto the manufacturing process or into the final product or both.(See Terminology F2312.)3.1.1.1 DiscussionIn this guide,adventitious agents alsoinclude microbiological or other infectious contaminants thatmay be endogenous to the starting cells or tissue.3.1.2 endotoxin,npyrogenic high molar mass lipopolysac-charide(LPS)complex associated with the cell wall ofgram-negative bacteria.3.1.2.1 DiscussionThough endotoxin
