Implementation of a new Syringe Filling Facility with Isolator Technology

Transcription

1 Implementation of a new Syringe Filling Facility with Isolator Technology BAXTER Bioscience Vienna, Austria Program Manager: Herbert Hrbek Presented by: Ernst Hetzl Menorca 1

2 Synopsis Program goal and structure Building Formulation unit Syringe design Filling line Isolator Timeline Video 2

3 Background Currently plasma derived immunoglobulines and vaccines are filled into syringes in the Vienna facility Due to increased market demand an extension of the syringe filling capacity is required Planning project for the conceptual design of a new syringe filling facility started mid 2007 Management decided early 2008 to start the project and approved the investment Due to the complexity of the project and impact to the existing facilities, the tasks are assigned to several projects and managed as a program 3

4 Program Goal Construction and implementation of a licensed production area for formulation and filling of liquid products in syringes to meet the communicated market demands Consolidation of primary packaging materials Manufacturing capacity of syringes/h Investment approximately 40 Mio Start routine operation by mid 2011 Authority approval of the new facility and products in EU and US 4

5 Program Structure 5

6 Layout New Facility 6

7 Sectionial View New Building 7

8 Layout Ground Floor Truck loading ramps Logistic zone (general area) Lockers (material, personnel) Production area (Iso 8 / EU D) o Cold storage area o Bulk-Formulation o Syringe filling in isolator (Iso 5 / EU A) o Washing and sterilization Connection to existing facility (general and production area) 8

9 Formulation Unit Formulation in closed system Mobile tanks (up to 1000 l) Separate boxes for 4 tanks CIP/SIP of tanks and piping Connection to filling line via hard pipe or hoses In-line sterilization and testing of filters PCS 7 process control system 9

10 Syringe Design Syringe with Readyject needle Syringe with tip cap 10

11 Filling Line - Overview Fully automatic filling line for 1-3 ml standard glass syringes ( ml liquid filled) Filling capacity: Unpacking Washing machine Sterilzation tunnel Isolator (filling and closing) Tray loading syringes/h Isolator technology with VHP sterilization SCADA control system 11

12 Syringe Filling Line - Unpacking Unpacking of syringe glass barrels from trays Conveying single glass barrels to washing machine 12

13 Syringe Filling Line - Washing Cleaning inside and outside with PW Last rinse with WFI Blow-drying inside and outside with filtered compressed air Silicone station to coat the container interior Automatic transfer to depyrogenation tunnel 13

14 Filling Line - Sterilization 3 Zones: drying, sterilization, cooling Dry heat for sterilization, depyrogenation and bake in of silicone Sterilizable cooling zone Continuous and stress free transport of the glass barrels through the tunnel. Tunnel is loaded and unloaded automatically row by row with special insertion and removal units 14

15 Filling Line Isolator Isolator with VHP sterilization Integrated design adapted to filling machine Situation of glove ports developed in mock up studies RTP ports for transfer of pre-sterilized Readyject needles, tip caps and stoppers VHP lock for transfer of equipment 15

16 Filling Line Filling and Closing Application of Readyject needle or tip-cap 8 positions filling with rotary piston pump Closing the syringe with the stopper Linear transport of syringes through working area Automatic rejects In process control samples for weighing CIP/SIP of filling system 16

17 Filling Line Tray Loading Conveying single prefilled syringes to tray loading Stacking prefilled syringes into trays for further storage 17

18 Timelines Start construction of the building Mar 2008 Start installation equipment Feb 2009 Start qualifications Jun 2009 Start media fills Feb 2010 Start conformance lot production Apr 2010 Process validation finished Sep 2010 Application for Manufacturing Authorization Apr 2010 Submission of variation 1 st product Q

19 Thank you very much for your attention Questions? 19

20 Clean Utilities Softening Unit (13,5 m³/h) Reversed Osmosis and EDI (5 m³/h) WFI Still (1,1 m³/h) Clean steam generator PW storage tank (20 m³) and loop WFI storage tank (10 m³) and loop Oil free and dry compressed air 20

21 Cleaning and Sterilization Washing machine for small equipment Autoclave CIP System: NaOH (2%, hot) and HNO 3 (1%) circulating in loops In-line sterilization of all formulation and filling tanks and piping 21