Unit 10 Ampoule line

1. Unit 10Ampoule line

2. Ampoule Washing Machine • Ampoule Filling-sealing Machine • Sterilizing/depyrogenation tunnels

3. Ultrasonic Rotary Ampoule Washing Machine • Cleaning station • Ultrasonic cleaning • Internal and external cleaning by spraying with recirculated water • Internal blow-dry with compressed air • Spraying with purified water • Internal blow-dry with compressed air • Sprayable with WFI (water for injectable) • Internal and external blow dry with compressed air 超声旋转安瓿清洗机

4. Ampoule Washing Machine • Washing process • Ultrasonic treatment • Recycle water (Internal and External) • Compressed air (Internal) • Purified water (Internal) • Compressed air (Internal) • WFI-water for injectable (Internal) • Compressed air (Internal and External) Vertical Rotary Ampoule/Vial Washing Machine 直立旋转式安瓿/药水瓶清洗机

5. Ampoule Filling-sealing Machine Filling-sealing process

6. Sterilizing/depyrogenation tunnels Two types 1) Radiant heat tunnels 2) Laminar Air Flow (LAF) tunnels Radiant heat tunnels use Infrared heating elements to heat vials by radiation. Laminar Air Flow tunnels apply heated and filtered air to heat vials by convection. The term “Laminar” is actually incorrect. There is little if any laminarity of air in a LAF tunnel. It would be more appropriate to speak of “Hot Air” tunnels.

7. Advantages of Hot Air tunnels over Radiant heat tunnels • Heat transfer by convection is faster than by radiation. • Particulates generated by the vials and the tunnel itself (transport belt) are continuously removed by HEPA filters. Hot Air tunnels are “cleaner” than Radiant heat tunnels. • Better control of air over-pressure in the clean room by balancing the air pressures in the three sections of the tunnel. • Better process control by automatically adjusting the air pressure and air velocity per section.

8. Sterilizing/Depyrogenation tunnels consist of three chambers 1) The infeed chamber 2) The sterilizing chamber 3) The cooling chamber 1) The infeed chamber 2) The sterilizing chamber 3) The cooling chamber

9. Entry zone Hot zone Cool zone Tunnel in the line Process Process Process Ampoules Entry (HEPA Filtered zone) AIR Ampoules Heating 250°C (sterilization + depyrogenation) Ampoules Zone @ 250° Ampoules Washing

11. Sterilizable Cooling Chamber • The depyrogenating tunnels with sterilizable cooling • chamber have the following features: • Heating elements for sterilizing the cooling chamber by means of dry heat; • Cooling chamber insulation to provide protection at temperatures up to 230°C; • Insulated airtight door at the tunnel exit, equipped with high temperature resistant inflatable gaskets, to protect the isolator during the cooling chamber sterilization and to enable the isolator to be sterilized without any leak of Vhp into the tunnel. Cooling Chamber, Heating Elements Automatic Tight Door

12. Automatic Discharge Of Final Vials In presence of isolator it is difficult for the operator to manually remove the remaining vials at the end of the batch. Therefore the depyrogenating tunnels are equipped with the automatic discharge bar to fully discharge the glassware at the end of the process. Automatic Discharge Bar

13. Thank you!