Products and Chemicals traceability at the European R&D Center

1. Products and Chemicals traceability at the European R&D Center Gilles DE LANGHE Friday 18th June 2010

2. Baxter International Inc. At Baxter, one of our primary goals is to save and sustain lives worldwide. • A leader in health care for more than 75 years. Baxter assists healthcare professionals and their patients with treatment of complex medical conditions including haemophilia, immune disorders, kidney disease, cancer, trauma and other conditions. • More than 45,000 employees around the world in more than 250 facilities • Manufacturing facilities worldwide • Local expertise drives competitive advantagein more than 100 countries

3. European R&D Center Alliance Park – Braine l’Alleud • More than 400 employees located in our new buildings gathering Business departments and R&D departments. • The Center focuses its activities on new product and process developments essentially for Renal, Medication Delivery and BioScience Businesses and ensures technical support for products currently on the market.

4. European R&D Center Warehouse Figures • Warehouse capacity > 1000 m³ • 1 000 locations • 15 000 boxes stored • 160 000 samples stored • 100 000 received samples per year • 1 500 samples prepared per week • Location Types : • Climatic rooms (monitored) • Fridges • Chemicals storage rooms

5. SIMSStock Inventory Management System • Purpose : Management and tracking of the deliveries for the laboratory to be received and managed in Baxter Alliance Park. It comprises the following deliveries: • Laboratory samples pallets • Laboratory samples boxes • Laboratory chemicals • Laboratory supplies • Tasks : • - Reception of the pallets in the warehouse • Identification and storage of the cardboard boxes in the • climatic chambers • - Preparation and identification of the samples for the laboratory • Tracking of the use in the laboratory by the analysts ; from the • opening of the bag until its destruction • Tasks : • Reception of chemicals • Identification and storage of the chemicals in dedicated storage • Tracking of the use in the laboratory by the analysts ; from the • opening of the container until its destruction Solution : Custom-built application (GAMP5) using RFID technology

6. B13245 Bag 1 25C/40%RH 12 M S1 Batch : Lot AA W12 Glucose 10% Single Container NOT FOR HUMAN USE SIMSTechnology and Equipment RFID Tag Tag HF 13.56 MHz ISO 15693 Chip Philips ICODE SLI Chemical Title # 1 Chemical type Reception date : 18 jun 2010 by: User Opening date: dd mm yyyy by: User 2 Primary expiry date : 18 aug 2011 Lot number Storage condition Purity Label date: dd mm yyyy

7. SIMSTechnology and Equipment Wallmount • Reading of tag in laboratories • Linked to a Touchscreen with • dedicated application • - 1 RFID antenna

8. SIMSTechnology and Equipment Tunnel • Reading of tags in laboratories • Linked to a Touchscreen with • dedicated application • - Set of 4 RFID antennas

9. SIMSTechnology and Equipment PDA • Use by Logistic Team members • Reading of RFID tags and CodeBar Reader for pallets • - Use with cradled mode or directly connected to server by Wifi

10. SIMSTechnology and Equipment RFID Printer Labels Printer • Generation of RFID tags after reception tasks • - Use by Logistic Team members • Use by chemicals users • Generation of label after opening • of a chemical container

11. SIMSProcess Comparison - Samples management process

12. SIMSProcess Comparison - Chemicals management process

13. SIMSValidation SIMS belongs to ‘GAMP5 category’ Software Main Steps • Baxter documents • User Requirements Specifications • Assessment • Supplier Audit (RFIDEA) • Supplier documents • Functional / Design Specification • Factory Acceptance Testing • Installation on Site • Installation Qualification • Site Acceptance Testing • Operational Qualification • Validation Plan Final Report

14. SIMSAdvantages Space availability • Accurate availabilities for each single storage location • Cardboard boxes volumes defined in the system • # Units/box defined in the system • Location volume defined in the system • Forecast availabilities at the different storage conditions • Dedicated report Samples identification • No double-check required (one by one, sequentially)

15. SIMSAdvantages Laboratory samples and Chemicals tracking • Automated using tunnel & wallmount • Enforced logical workflow • Information more complete • Information can be queried easily • Unique tool for management of laboratories components (samples and chemicals)

16. SIMS Questions?

17. SIMS Thankyou for your attention !