1、Designation:E209700(Reapproved 2014)Standard Guide forDetermining the Impact of Extractables from Non-MetallicMaterials on the Safety of Biotechnology Products1This standard is issued under the fixed designation E2097;the number immediately following the designation indicates the year oforiginal ado
2、ption 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.1.Scope1.1 This guide covers procedures and test methods forprocess component qualificati
3、on by the end user.The goal is toassess the safety impact of extractables from non-metallicprocess components used in contact with bioprocessing solu-tions.This encompasses the impact of extractables on thesafety of the final product as it passes through the variousstages of the manufacturing proces
4、s.This guide is not designedfor evaluation of metallic materials,final product container/closures or those components intentionally added to the prod-uct or production streams during the manufacturing process.Testing of solids and extracts is specified in other ASTMstandards.Materials must be qualif
5、ied by specific use.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 There is no companion guide available.1.4 Safety/Fire Hazards:Extractions with organic solventswill be infrequent under this guide,but,when used must bet
6、reated as potential fire/explosion hazards.1.5 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 appro-priate safety and health practices and determine the applica-bility of regulatory
7、limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D4951 Test Method for Determination of Additive Elementsin Lubricating Oils by Inductively Coupled PlasmaAtomic Emission SpectrometryF619 Practice for Extraction of Medical Plastics3.Terminology3.1 See the Dictionary of Engineering S
8、cience and Technol-ogy.Review with Subcommittee E48.91 on Terminology.SeeSection A7 on Terminology and Part E on Terminology inASTM Standards in Form and Style for ASTM Standards fordetails.3.2 Definitions:3.2.1 biopharmaceuticalany drug product produced fromliving organisms.3.2.2 biotechnology solu
9、tiona solution containing or pro-ducing products from living microbial,animal or plant cells orby the enzymes from those cells.3.2.3 biotechnology producta discrete chemical entityproduced by growing single cell organisms with unique geneticinformation.3.2.4 elution cytotoxicitysee USP.3.2.5 emissio
10、n spectrographic analysis(ESA)an analyti-cal technique for determining metals in a sample vaporized ina plasma arc.3.2.6 extractablesresidues from solid process componentsnot intentionally part of the product process stream.3.2.7 fermentationthe biochemical reaction process wheremicroorganisms in a
11、nutrient medium convert a feedstock to aproduct.3.2.8 inductively coupled plasma(ICP)an analytical tech-nique designed to quantitate chemical elements.3.2.9 materials of constructionhigh molecular weight orsolid materials,used in biopharmaceutical process equipmentwhich contact process solutions and
12、 can potentially releaseextractable residues.3.2.10 non-volatile residue(NVR)non-volatile materialremaining after evaporating a solvent into which the residuehas been extracted(see USP).3.2.11 oxidizable substances(OS)chemical compoundswhich may be oxidized by potassium permanganate underspecified c
13、onditions(see USP).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.Origi
14、nallyapproved in 2000.Last previous edition approved in 2006 as E2097 00(2006).DOI:10.1520/E2097-00R14.2For 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 Docu
15、ment Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.12 product contact materiala material which physi-cally contacts a solution containing the chemical entity desig-nated the product.3.2.13 process mat
16、erialshigh molecular weight or solidmaterials which contact process solutions potentially releasingextractable residues.3.2.14 purificationthe process by which the desired prod-uct is separated from the production process solution.3.2.15 residue on ignition(ROI)the residue remainingafter ashing a material at high temperature.3.2.16 total organic carbon(TOC)an analytical techniquefor measuring the carbon associated with organic molecules ina solution.4.Significance and Use4.1 This guide applies t
