1、Designation:E305116Standard Guide forSpecification,Design,Verification,and Application ofSingle-Use Systems in Pharmaceutical andBiopharmaceutical Manufacturing1This standard is issued under the fixed designation E3051;the number immediately following the designation indicates the year oforiginal ad
2、option 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 is intended as a complement to Guide E2500.1.2 This guide is appli
3、cable to the range of manufacturingsystems described in Guide E2500,specifically all elements ofsingle-use systems,or hybrids of single-use and traditionalcomponents,used for the manufacturing of pharmaceutical andbiopharmaceuticalproducts,including:materialsofconstruction,components,assembly,manifo
4、lds,supportingutilities,associated process monitoring and control systems,automation systems,and controlled environment that have thepotential to affect product quality and patient safety.1.3 This guide is applicable for the implementation ofchanges to manufacturing system design for existing system
5、s.It may be used for continuous improvement and changes inoperation from clinical through to commercial scale.1.4 For brevity,single-use systems are referred to as SUSthroughout the rest of this guide.1.5 The approach may be applied by the end user,thesupplier of SUS,and raw materials sub-suppliers
6、further backin the supply chain.1.6 This guide is not intended to apply to the use ofsingle-use technology for packaging,primary containers,com-bination products(products composed of any combination of adrug,device,or biological product)or devices.1.7 This guide does not address specific local requi
7、rements,which remain the responsibility of the end user.1.8 This guide does not address employee health and safety,environmental,nor other good engineering and manufacturingpractices(GXP)requirements.This standard does not purportto address all of the safety concerns,if any,associated with itsuse.It
8、 is the responsibility of the user of this standard toestablish appropriate safety and health practices and deter-mine the applicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D4169 Practice for Performance Testing of Shipping Con-tainers and SystemsE2363 Te
9、rminology Relating to Process Analytical Technol-ogy in the Pharmaceutical IndustryE2500 Guide for Specification,Design,and Verification ofPharmaceutical and Biopharmaceutical ManufacturingSystems and Equipment2.2 United States Pharmacopeia:3USP Particulate Matter in InjectionsUSP Visible Particulat
10、es in Injections2.3 International Conference on Harmonization of Techni-cal Requirements for Registration of Pharmaceuticals forHuman Use(ICH):4ICH Q7 Good Manufacturing Practice Guide for ActivePharmaceutical IngredientsICH Q8(R2)Pharmaceutical DevelopmentICH Q9 Quality Risk ManagementICH Q10 Pharm
11、aceutical Quality System2.4 ISO Standards:5ISO 13485:2003 Medical DevicesQuality ManagementSystemsRequirements for Regulatory PurposesISO 14644 Cleanrooms and Associated Controlled Environ-mentsISTA 3A General Simulation Performance tests2.5 U.S.Food and Drug Administration(USFDA):6Guidance for Indu
12、stry Process Validation:General Prin-ciples and Practices1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical and Biopharmaceutical Products and is the direct responsibility ofSubcommittee E55.03 on General Pharmaceutical Standards.Current edition approved Feb.
13、1,2016.Published March 2016.DOI:10.1520/E3051-16.2For 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 Document Summary page onthe ASTM website.3Available from U
14、.S.Pharmacopeial Convention(USP),12601 TwinbrookPkwy.,Rockville,MD 20852-1790,http:/www.usp.org.4Available from International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use(ICH),ICHSecretariat,9,chemin des Mines,P.O.Box 195,1211 Geneva 20,Switz
15、erland,http:/www.ich.org.5Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.6Available from U.S.Food and Drug Administration(FDA),10903 NewHampshire Ave.,Silver Spring,MD 20993,http:/www.fda.gov.Copyright ASTM International,100 Ba
16、rr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Pharmaceutical cGMPs for the 21st Century,A Risk-BasedApproach2.6 European Medicine Agency:Commission Directive 2003/94/EC of 8 October 20032.7 Other Publications:PDA Technical Report No.66 Application of Single-UseSystems in Pharmaceutical ManufacturingConsensus QualityAgreement Template for Single-Use Bio-pharmaceutical Manufacturing Products BioProcess Sys-tems Alliance7TAPPI Standard Practice T 564 sp-113.Terminology3
