案例阶段封面sartorius stedim biotechdphsip exh filt.pdfVIP

PhaseSpecificationCoverSheetSartoriusStedimBiotech

PhaseSpecification

SIP_EXH_FILT

SterilizationofExhaustFiltBioreactor

InstancesinUSPUnits:

BR203:PH104_SIP_EXH_FILT

BR204:PH104_SIP_EXH_FILT

BR207:PH104_SIP_EXH_FILT

BR208:PH104_SIP_EXH_FILT

ProjectNo.SartoriusRevision

PH_PH104_

200LmAbPilotnt(USPDSP)03

SIP_EXH_FILT

Project-No.Sartorius

1306-5018

NameDateSignature

Prepared:SartoriusB.Schäfer17.07.2014

Reviewed:Sartorius

Reviewed:

Approved:

File:PH_PH104_SIP_EXH_FILT_03.xlsPage1of9

PhaseSpecificationInfoSheetSartoriusStedimBiotech

1.Purpose

ThePhaseSpecificationprovidesadescriptionforthephaseexecutionandassociatedinformationfor

thesoftwareimplementation.

SeparatePhaseSpecificationsareavailableforeachindividualMasterPhase.

2.Method

ThePhaseSpecificationissubdividedintothefollowingsections:

-Description

-SFC

-ParameterTable

-StartPermissiveTable

-HoldConditionTable

-ActionTable

-ReportTable

ThesectionDescriptionprovidesabriefdescriptionofthepurposeofthePhase.

Ifapplicable,amarkedupPFDthathasbeenprepare