ASTM_E_1287_-_89_1999.pdf

Designation:E 1287 89(Reapproved 1999)Standard Practice forAseptic Sampling of Biological Materials1This standard is issued under the fixed designation E 1287;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 practice presents the principles,state-of-the-artconcepts and generally accepted methods for aseptic samplingof materials involved with or produced by biotechnical pro-cesses where contamination of either the sample or the sourceof the sample cannot be accepted.These processes couldinvolve living organisms such as virus,bacteria,yeasts,andmammalian cells or biologically active constituents,such asenzymes and biochemicals that must exist in a noncontami-nated state.1.2 This practice also applies to the products from thesebioprocesses that can be for human consumption,sterile orparental drug applications,which also require aseptic samplingto meet regulatory,current good manufacturing practices,orother quality control requirements.1.3 WarningSince some biotechnical processes couldproduce flammable products,this sampling practice should beapplied only after taking into account all of the factors that arepertinent to an assessment of the fire hazard of a particular enduse.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 appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:D 1356 Terminology Relating to Atmospheric Samplingand Analysis2D 4177 Practice for Automatic Sampling of Petroleum andPetroleum Products3E 884 Practice for Sampling Airborne Microorganisms atMunicipal Solid-Waste Processing Facilities43.Terminology3.1 The definitions covered in Terminology D 1356,Prac-tice D 4177,and Practice E 884 are applicable to this practice.3.2 Definitions:3.2.1 aseptic samplingsampling process in which no ex-traneous microorganisms or substances are introduced into thesample or its original bulk material as a result of the samplingsystem and activity.3.2.2 current good manufacturing practices(CGMP)current regulations published by the United States Food andDrugAdministration(FDA)regarding manufacturing,process-ing,packaging and storing of drug and biological products.3.2.3 dead legany inactive,trapped or stagnant zone of abiological fluid that is to be sampled aseptically where thisliquid zone would not be representative of the bulk fluid that isto be sampled.This 88dead leg zone could deviate from thebulk system in oxygen content,nutrients levels,materialcomposition,temperature,bacterial contamination,and otherprocess variables that would prevent any sample drawnthrough this system from representating the bulk fluid qualityto be tested.3.2.3.1 DiscussionThis definition may be more restrictivethan the FDA definition which is any unused pipe greater inlength than six of its internal diameters.Since valve designsand presence of other devices in the sampling system must beconsidered in this aseptic sampling procedure,the entiresampling system from bulk fluid to sample container should bevalidated by using proper biological challenges to show thatthe intended sterility and sample quality objective can be metand reproduced within the prescribed limits of the specificprocess.3.2.4 pathogenicdisease causing.3.2.5 sterilefree of any living organism.3.2.6 validationthe quality assurance evaluation of anitem of equipment or overall process wherein the equipment orprocess,or both,is challenged to perform under the“worstcase”conditions of process variables and applicable micro-organism contamination to meet preestablished acceptancecriteria.4.Summary of Practice4.1 Ageneral description of aseptic sampling-system designguidelines is included either to remove a representative sampleof the bulk fluid for external testing,or to directly measure thefluid properties in-situ.Validation of sampling equipment andmethods is also described.Suggested sample system designsare presented for consideration and application as appropriateto specific processes.Where possible,the advantages and1This practice is under the jurisdiction of ASTM Committee E-48 on Biotech-nology and is the direct responsibility of Subcommittee E48.03 on Unit Processesand Their Control.Current edition approved Feb.24,1989.Published April 1989.2Annual Book of ASTM Standards,Vol 11.03.3Annual Book of ASTM Standards,Vol 05.02.4Annual Book of ASTM Standards,Vol 11.05.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.disadvantages of different sample removal designs are pre-sented.Fabrication and maintenance considerations are alsodiscussed.The Appendix includes general