Aseptic vial filling line
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1 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
2 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
3 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
4 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
5 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
6 Basic concept Basic concept of the vial filling line manufacturer: Optima 6
7 Layout depalletizing robot capper palletizing robot vial washer SHT filling machine 7
8 Clean room concept 8
9 Depalletizing system Depalletizing robot fully automated depalletizing in layers fully automated interlayer-lift-off automated placement of vials 9
10 Vial washing machine Vial washing machine linear transportation system paternoster cleaning and drying of vials 10
11 Sterilization hot-air tunnel 11
12 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
13 Filling machine 13
14 Filling machine 14
15 Product paths emulsion solutions filling machine CIP/SIP path EM path solutions media management system LVP Copyright Fresenius Kabi AG
16 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
17 Filling system 17
18 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
19 100% 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 LoLo-limit HiHi-limit 19
20 Stoppering system two stoppering modules stopper supply 20
21 Stoppering system Details movable stoppering modules redundant CIP/SIP for both modules evacuation and nitrogen gassing for oxygen sensitive products 21
22 Isolator / VHP gloves connector for stopper container 22
23 Isolator / VHP Details VHP cycle: sterilization with H 2 O 2 laminar flow 23
24 Capper Details infeed eight-digit capper product reject caps supply vibration cap sorter outfeed rejected products 24
25 Palletizing robot Details palletizing of vial-rows picker arm fully automated interlayer placement 25
26 Line performance pieces/hour infusion vial WM SHT FM Capper 50ml ml ml ml injection vial WM SHT FM Capper 50H H
27 Any questions? 27
28 Backup 28
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