Designation:E1287–89(Reapproved1999)StandardPracticeforAsepticSamplingofBiologicalMaterials1ThisstandardisissuedunderthefixeddesignationE1287;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticepresentstheprinciples,state-of-the-artconceptsandgenerallyacceptedmethodsforasepticsamplingofmaterialsinvolvedwithorproducedbybiotechnicalpro-cesseswherecontaminationofeitherthesampleorthesourceofthesamplecannotbeaccepted.Theseprocessescouldinvolvelivingorganismssuchasvirus,bacteria,yeasts,andmammaliancellsorbiologicallyactiveconstituents,suchasenzymesandbiochemicalsthatmustexistinanoncontami-natedstate.1.2Thispracticealsoappliestotheproductsfromthesebioprocessesthatcanbeforhumanconsumption,sterileorparentaldrugapplications,whichalsorequireasepticsamplingtomeetregulatory,currentgoodmanufacturingpractices,orotherqualitycontrolrequirements.1.3Warning—Sincesomebiotechnicalprocessescouldproduceflammableproducts,thissamplingpracticeshouldbeappliedonlyaftertakingintoaccountallofthefactorsthatarepertinenttoanassessmentofthefirehazardofaparticularenduse.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:D1356TerminologyRelatingtoAtmosphericSamplingandAnalysis2D4177PracticeforAutomaticSamplingofPetroleumandPetroleumProducts3E884PracticeforSamplingAirborneMicroorganismsatMunicipalSolid-WasteProcessingFacilities43.Terminology3.1ThedefinitionscoveredinTerminologyD1356,Prac-ticeD4177,andPracticeE884areapplicabletothispractice.3.2Definitions:3.2.1asepticsampling—samplingprocessinwhichnoex-traneousmicroorganismsorsubstancesareintroducedin...
