ADC项目的生命周期管理

Lin Manyang2025.09.18 Agenda Life Cycle Model – ASTM 2500 Life Cycle Model - ISPE GEP this Guide is to Supports andEnables the design, delivery, and operation of engineered systems in regulated industry. Life Cycle Model-Innovent Life Cycle Execution Blueprint - Innovent Project Philosophy Knowledge of Life Cycle Management CQV Life Cycle Map – ISPE C&Q Life Cycle Risk Management-Base On ICH Q9 Agenda 1Life Cycle Management of Projrct Samsung ADC Plant Study Samsung ADC Plant Study Reference on Containment Strategy Pontent Compounds OEL & OEB OEB/OEL Containment Guide HVAC systems serving areas processing these toxic and high potency materials must be designed with risk-based consideration of the appropriate degree ofAHU sharing and filtered recirculation or 100% outside air. It may be necessary to employ “safe-change” filters to capture contaminants. ADC Process andPrimaryContainment ADC Containment Strategy ADC DP Filling Line Consideration Agenda 1Life Cycle Management of Projrct 2Containment & Safety Requirements ADC 4Layout and HVAC 5Isolator System 6Filtration and PUPSIT EU GMP Annex1 and CCS üHarmonization of global pharmaceuticalstandards(EMA, WHO, PIC/S jointly drafted) üChina's NMPA will also release a new version ofSterile Drugs Annex 1 in 2025 (a draft forcomments was released in March) üThe most comprehensive, detailed, technical,and the current version üInitiate hardware, software, and documentationupgrades for sterile product (include Greenfieldproject, or existing plant) Facilities is Critical Elements of a CCS I.Design of both the plant and processesII.Premises and equipmentIII.Utilities.IV.Raw material controlsV.Product containers and closuresVI.Vendor approvalVII.Management of outsourceVIII.Process risk managementIX.Process validationX.Validation ofsterilisationprocessesXI.Preventative maintenanceXII.Cleaning and disinfectionXIII.Monitoring systemsXIV.Prevention mechanismsXV.Continuous improvement Elements to be considered within a CCS(EU GMP Annex1) CCS of Low-Bioburden Drug Substance CCS of Sterile Drug Product CCS of Cleaning and Disinfection Agenda 1Life Cycle Management of Projrct 2Containment & Safety Requirements ADC 3EU GMP Annex1 and CCS 5Isolator System Layout Design -Sources of Contamination Boundary for Open and Clouse System ISPE : Open System with Isolators Plant P & M Flow Personnel: semi unidirectionalMaterial : unidirectionalAdvantage: reuse of CNC/D garments Personnel: unidirectionalMaterial : unidirectionalAdvantage: less No. of AL, no dedicated personnel return corridor Airlock Configurations-C/D to B Agenda 1Life Cycle Management of Projrct 2Containment & Safety Requirements ADC 3EU GMP Annex1 and CCS 4Layout and HVAC 5Isolator System 6Filtration and PUPSIT Open Isolators Vs. Close Isolator EU Annex1 2022 Version NMPA Annex 2025 Draft EU GMP Annex1 Vs. PDA TR34 Annex1 2022 Version PDA TR34 2001 Version 2.0 TYPES OF ISOLATORS 2.1 Closed Isolators2.1.1 Closed Isolators Intended for Aseptic Applications(positive pressure)2.1.2 Closed Isolators Intended for Containment Applications(negative pressure)2.1.3 Closed Isolators Intended for Asepsis and Containment(positive pressure,negative pressure airlocks 2.2 Open Isolators2.2.1 Open Isolators Intended for Aseptic Applications((positive pressure)2.2.2 Open Isolators Intended for Asepsis and Containment Isolator Classification- ISPE Closed isolatorsare typicallyused for batch processes that do not require a high number of components to be processed. Material is placed inside theisolator before a decontamination cycle is performed, or material is transferred in via decontamination airlocks. Typical applications for a closedisolator are for a formulation process or for sterility testing. Open isolatorsareused in continuous process applications. Material is continuously transferred into the isolator via appropriate decontamination orsterilization devices. A differential pressure zoning concept guarantees a continuous airflow towards the surrounding environment to preventparticulate or microbiological ingress through transfer openings Type Open Isolator for ADC Filling line Decontamination for Isolators Annex1-4.22 Design for Qualification Annex1 4.25 4.23 Cleanrooms and clean air equipment such asunidirectional airflow units (UDAFs), RABS and isolators,used for the manufacture of sterile products,should be qualified according to the required characteristics of the environment. Aseptic Vs. Aseptic Filling of ADC Aseptic Vs. Aseptic Filling of ADC ADC Isolator HVAC Systems FIPA Cartridge Filter Vs.BIBO Filter lNo extra space for BIBO filter in technical area neededlReturn air ducts protected with cartridge filters(no wash down required）lSafe change filter (FIPA) system located next to filling arealManual Spray guns for wetting and cleaning FIPA cartridge filter System BIBO Filter Vs. FIPA Cartridge Filter FIPA Cartridge Filter Agenda 1Life Cycle M