ASTM_E_1567_-_93_2001.pdf

Designation:E 1567 93(Reapproved 2001)Standard Guide forBiopharmaceutical Facilities Architectural DesignConsiderations1This standard is issued under the fixed designation E 1567;the number immediately following the designation indicates the year oforiginal adoption or,in the 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.1.Scope1.1 This guide covers architectural design considerations forbuildings and facilities used in the biological processingindustry to make drugs,chemicals,and other products.1.2 These designs are intended to meet current good manu-facturing practices(cGMP)criteria and guidelines publishedby the U.S.Food and DrugAdministration(FDA)for processesand products manufactured under CFR Title 21.1.3 While the guidelines described are general in nature,they are not expected to apply to all of the possible biotechnicalprocesses used in the industry today.Accordingly,the user ofthis guide must exercise good engineering judgment in specificdesign applications to select the proper guidelines that apply.1.4 In addition to the cGMP guidelines provided herein,other regulations and guides should be considered that arepromulgated by other federal agencies such as the Occupa-tional Safety and Health Administration(OSHA),the U.S.Environmental Protection Agency(EPA),the U.S.Drug Ad-ministration(USDA),the National Institute of Health(NIH),and so forth.1.5 While the buildings will be designed to meet specificfunctional requirements and comply with local zoning ordi-nances,building codes,handicapped employee standards,andso forth,these considerations are not included in this guide.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 problems,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 Documents2.1Code of Federal Regulations:CFR Title 21,Parts58,210,211,212,606,809,82022.2Other Document:NIH Guidelines,Containment Area Designations33.Terminology3.1 Definition:3.1.1 cGMPabbreviation for current good manufacturingpractices as defined in CFR Title 21,Parts 210 and 211.4.Significance and Use4.1 This guide is intended for use in designing laboratory,pilot plant,commercial production buildings that will useprocesses involving living organisms to produce products.These products are also manufactured under the FDAand otherfederal agency regulations.4.2 These guidelines include the layout of facilities,designof containment areas,ventilation and air quality,personnelareas,special processing hazards,controlled environment ar-eas,and other items.4.3 This guide is for use by engineers,architects,andowners of biopharmatechnical manufacturing facilities to con-sider the special factors in laying out the facilities to meetcGMP requirements and other good engineering principles.4.4 By using these guidelines along with other designcriteria required by a variety of regulatory agencies,a valida-tion effort can be achieved more easily to meet agencyrequirements and obtain operating permits.4.5 This guide is intended to provide general guidelines forconsideration and application in a variety of plant operationsand processes in which the designers can make specificdecisions concerning the exact architectural design features touse.5.Summary of Guide5.1 This guide provides architectural design principles toconsider when applying federal regulations to biopharmatech-nical plant facilities construction and functions.Check lists forspecific plant operation activity areas presented with criteriafor their design and layout considerations.Environmentalconsiderations are also included for aseptic and special laminarflow zones of operation.Fermenter area layout and spaceconsiderations are presented.When containment and closed1This guide is under the jurisdiction ofASTM Committee E48 on Biotechnologyand is the direct responsibility of Subcommittee E48.03 on Unit Processes andValidation.Current edition approved Aug.15,1993.Published October 1993.2Available from Standardization Documents Order Desk,Bldg.4,Section D,700 Robbins Ave.,Philadelphia,PA 19111-5094,Attn:NPODS.3Available from National Institutes of Health,(NIH),9000 Rockville Pike,Bethesda,MD 20892.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.area operations are necessary,the general criteria to be consid-ered by the designer is presented based on NIH Guidelines andgood engineering practices.5.2 Plant layout considerations are included for all normalsections of a biotechnical operating plant.6.Guidelines6.1 First,establish which regulations apply to the specificproject design.Review 21 CFR,Parts 210,211,212,and soforth;NIH Gui