Pharma Forum - Schwäbisch Hall September 26, 2013 Aseptic vial filling line implementation of two separated filling paths including inline CIP/SIP Contact information Dr. Alexander Hohl Fresenius Kabi Austria Graz Copyright Fresenius Kabi AG
Project targets Development of a fully automated vial filling line aseptic and non-aseptic filling two separated filling paths automated inline connection to two separated preparation systems two time-pressure filling systems inline CIP/SIP for both filling paths 100% IPC at maximum line speed Isolator/cRABS and VHP-cycle Extension of existing building 2
Key features Aseptic filling line for infusion/injection vials depalletizing robot linear vial washer sterilization hot-air tunnel filling and closing machine capper palletizing robot Additional components isolator / crabs media management system particle monitoring, microbial air sampler clean room stopper autoclave peripheral components (e.g. HVAC) 3
Format overview infusion vial 50ml 100ml 250ml 500ml neck size Form A (32mm) Form A (32mm) Form A (32mm) Form A (32mm) injection vial 50H 100H 4
Timeline Timeline Order (October 2011) FAT (January 2013) Implementation (January - April 2013) Qualification (April/May 2013) SAT (May 2013) Start of production (End of May 2013) 5
Basic concept Basic concept of the vial filling line manufacturer: Optima 6
Layout depalletizing robot capper palletizing robot vial washer SHT filling machine 7
Clean room concept 8
Depalletizing system Depalletizing robot fully automated depalletizing in layers fully automated interlayer-lift-off automated placement of vials 9
Vial washing machine Vial washing machine linear transportation system paternoster cleaning and drying of vials 10
Sterilization hot-air tunnel 11
Filling machine Vial filling machine intermittent motion filler redundant filling systems and stoppering systems both aseptic and non aseptic filling isolator with VHP-cycle media management system (in-house engineering) Filling system separated filling paths for emulsion and solution nitrogen gassing while filling fractionated vacuum process for oxygen sensitive products two time-pressure filling devices one for each filling path 12
Filling machine 13
Filling machine 14
Product paths emulsion solutions filling machine CIP/SIP path EM path solutions media management system LVP Copyright Fresenius Kabi AG
Filling system emulsion section two time-pressure filling devices eight connectors (emulsion) solution section infeed turn table eight connectors (solution) segment wheel 8 nozzels per filling path 16
Filling system 17
CIP/SIP-system Details CIP/SIP washing position (emulsion path) simultaneous CIP/SIP and vial filling media management system CIP/SIP washing position (solution path) 8 nozzels per filling path 18
100% IPC Details continuous control of filling weight for each vial/bottle measurement of weight before filling and after filling calculation of netto weight and filling volume - four weight cells for netto weight measurement - four weight cells for brutto weight measurement 1 2 3 4 5 6 7 8 LoLo-limit HiHi-limit 19
Stoppering system two stoppering modules stopper supply 20
Stoppering system Details movable stoppering modules redundant CIP/SIP for both modules evacuation and nitrogen gassing for oxygen sensitive products 21
Isolator / VHP gloves connector for stopper container 22
Isolator / VHP Details VHP cycle: sterilization with H 2 O 2 laminar flow 23
Capper Details infeed eight-digit capper product reject caps supply vibration cap sorter outfeed rejected products 24
Palletizing robot Details palletizing of vial-rows picker arm fully automated interlayer placement 25
Line performance pieces/hour infusion vial WM SHT FM Capper 50ml 6.500 6.860 6.800 7.200 100ml 6.500 6.860 6.800 6.600 250ml 3.470 3.470 4.400 4.800 500ml 2.000 2.395 2.400 2.400 injection vial WM SHT FM Capper 50H 6.800 6.860 6.800 7.200 100H 6.500 6.860 6.800 6.600 26
Any questions? 27
Backup 28