Dual Chamber Syringe. Design and Development of a

Transcription

1 Dual Chamber Syringe Design and Development of a customized Syringe Filling Line Herbert Hrbek, Anes Halilovic Pharma Forum Schwaebisch Hall, Sep 26 th

2 Agenda Introduction Baxter BioScience in Austria Project Scope Building and Infrastructure Syringe design Equipment Project management Challenges Lessons Learned 2

3 Introduction Baxter BioScience in Austria 3

4 Baxter Inc. Baxter is a global, diversified healthcare company applying innovative science to develop specialty therapeutics and medical products that save and sustain patients lives. Every day, our products and services help treat thousands of people around the world with some of the most complex conditions from hemophilia to immune disorders to kidney disease. 4

5 Company Snapshot More than 75 years of market leadership driven by a well-recognized global brand $14.2 billion global market leader $1.5 billion invested in R&D in 2012 Nearly 60% of sales outside the United States 5

6 Global Presence Approximately 50,800 employees in more than 65 countries Manufacturing facilities in 27 countries Products sold in more than 100 countries More than half of sales and earnings come from outside the United States 6

7 Baxter BioScience in Austria Largest Baxter location ~ 80% of the BioScience product portfolio in the area of Plasma Proteins, BioSurgery, Recombinant Products and Vaccines More than 4,000 employees Manufacturing facilities Plasma fractionation, purification and filling & finishing the broadest product portfolio in industry Vaccines production Recombinant products filling Plasma collection and control BioScience R&D headquarter 7

8 Austria Manufacturing Sites 6 Manufacturing sites Licensed by U.S. FDA and EU regulatory authorities Manufacturing Employees: ~ 2,200 Products: 22 Biologics Final product units: ~ 20 MM in 2009 Dispatch: in more than 94 countries Operations: 24 hours per day, year-round 88

9 Fibrin Sealant Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. 9

10 Fibrin Sealant About ARTISS ARTISS [Fibrin Sealant (Human)], Vapor Heated, Solvent Detergent Treated, (ARTISS) is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein (Human) and Thrombin (Human), mimic the final stage of the blood coagulation cascade. 10

11 Project Scope 11

12 Project Scope - Fibrin Sealant Supply Capacity Project Developing an improved syringe that meets customer ease-of-use expectations Build a new building next the current production site Implement a new filling line based on proven technology Implement associated supporting equipment Increasing the production capacity to meet the expected demand Increase reliability and performance of production process for Fibrin Sealants 12

13 Building and Infrastructure 13

14 Filling Building Project scope: Build modular expandable manufacturing building to fill Fibrint Sealant. Project time line: Start construction: Feb 2012 Building construction finished: Mar 2013 All equipment delivered: Jun 2013 Commissioning and start up: Dec 2013 Technical data: 4 Floors (basement, production floor and 2 Technical floors) Foot print: apx. 500 m² Production area: apx. 380 m² Technical area: apx. 800 m²

15 Side View of Filling Building 15

16 Layout 16

17 Building 17

18 Syringe Design 18

19 Syringe Design Design developed in cooperation with Raumedic, which will also be the supplier of the syringes Dual chamber syringe Two syringe sizes 2/4ml and 10ml Delivered assembled in tubs and gamma pre-sterilized One of proposed syringe designs 19

20 Syringe Design Syringe assembly Filled syringe Filled and pouched syringe 20

21 Tub / Nest Tub ready for process Syringe layout in the nest 21

22 Equipment 22

23 Filling Line Design Requirements: Using proven existing technology as much as possible Filling and pouching in grade A Single use technology as much as possible to avoid CIP/SIP process of the filling line Robust process 23

24 3D Design Review Filling Tub unloading Pouch loading Pouching De-Lidding 24

25 Line Components Filling line components: De-bagging De-lidding Filling Pouching 25

26 De-Bagging Semi automatic de-bagging station with vacuum used to support the bag opening and manual pusher to push the tub on to the slide without direct tub contact. 26

27 De-Lidding De-lidding with optional manual delidding, due to the uncertainty of the process at the supplier of the tubs. 27

28 Filling Bottom filling by puling product Connection to the product tank via sterile connectors and silicon tubing prepared for a single use and assembled prior to sterilization Cleaning and assembling in class D and sterilized via autoclave 28

29 Syringe Transfer Two Staubli robots used for precise handling of syringes during the process First robot is used to transfer syringes from the nest to to the oval transport, after Lasering and camera inspection station. 29

30 Pouching Second Staubli robot is used to transfer syringes from filling area to the pouching station 30

31 Pouching Pouch transport, preparation for syringe insertion and welding station 31

32 Autoclave Steam Autoclave 1m 3 chamber size Double door pass-through from grade D to grade B Used for direct product contact parts and other size parts 32

33 Decontamination Chamber VHP Decontamination Chamber Chamber size 5m 3 Cart loading and unloading Pass through from D to B Used for supporting material, product tanks, pouches and machine size parts 33

34 Project Management, Challenges and Lessons Learned 34

35 Project management pass way to success Started engineering study, January Filling test at Optima with buffer solution and in Vienna with original product using pilot filling unit, to prove filling process, September Contract signed in Vienna, March Kickoff meeting SHA / risk assessment, April 2012 Filling test DQ SHA, August D walk through design of the line Meeting with Optima in Wien, August 2012 Layout / interface discussion together with clean room supplier (walls, air handling units, ceiling) De-lidding test with Raumedic, December D design review 35

36 Project management pass way to success Raumedic's involvement during the process: Kick off meeting with Raumedic, Optima, Baxter and R&A (sub supplier of syringe assembly machine). Present during filling test. Present during de-lidding test. Pre-FAT to define length of the bag and discus potential optimization. Discussions and meetings between Raumedic and Optima as needed. Baxter engineering visits approximately every 6 weeks until the FAT. Follow up with all suppliers on the schedule and update the suppliers on any design changes, packaging material or equipment. Dec Feb

37 Project management pass way to success Pre-FAT, April 2013 Assessing the line prior to FAT, Testing new pouch material with Sengewald. FAT, Jun 2013 Post-FAT, Jun 2013 Follow up on pouch handling challenges April 2013 Delivery and installation, Jun Commissioning, engineering runs and SAT, July & August Engineering runs performed to evaluate the line prior to validation. Currently in validation phase. July

38 Challenges Finding machine supplier for complete process Transporting syringes in to the grade A Designing of the syringe to meet both costumers expectations: users (doctors and nurses) manufacturing Working with many different suppliers: clean room filling and pouching line manual pouching syringe supplier and sub-suppliers (assembling machine, stoppers, tub) pouch supplier 38

39 Lessons learned Involve syringe and pouch suppliers in machine design Involve machine supplier in syringe and pouch design Perform engineering study prior to choosing the supplier Adopt your device design to the current technology as much as possible (e.g. tub/nest) 39

40 Thank you for your Attention Questions? 40