Unit 10 Ampoule line

Ampoule Washing Machine

Ampoule Filling-sealing Machine

Sterilizing/depyrogenation tunnels

Ultrasonic Rotary Ampoule Washing Machine

超声旋转安瓿清洗机

Cleaning stationUltrasonic cleaningInternal and external

cleaning by spraying with recirculated waterInternal blow-dry

with compressed airSpraying with

purified waterInternal blow-dry

with compressed airSprayable with WFI

(water for injectable)Internal and external

blow dry with compressed air

Vertical Rotary Ampoule/Vial Washing Machine直立旋转式安瓿 /药水瓶清洗机

Washing processUltrasonic treatmentRecycle water

(Internal and External)Compressed air

(Internal)Purified water

(Internal)Compressed air

(Internal)WFI-water for

injectable (Internal)Compressed air

(Internal and External)

Ampoule Filling-sealing Machine

Filling-sealing process

Sterilizing/depyrogenation Sterilizing/depyrogenation tunnelstunnels

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.

Two types1) Radiant heat tunnels 2) Laminar Air Flow (LAF) tunnels

Advantages of Hot Air tunnels Advantages of Hot Air tunnels over Radiant heat tunnelsover Radiant heat tunnels

Heat transfer by convection is faster than by Heat transfer by convection is faster than by radiation.radiation.

Particulates generated by the vials and the Particulates generated by the vials and the tunnel itself (transport belt) are continuously tunnel itself (transport belt) are continuously removed by HEPA filters. Hot Air tunnels are removed by HEPA filters. Hot Air tunnels are “cleaner” than Radiant heat tunnels. “cleaner” than Radiant heat tunnels.

Better control of air over-pressure in the clean Better control of air over-pressure in the clean room by balancing the air pressures in the room by balancing the air pressures in the three sections of the tunnel. three sections of the tunnel.

Better process control by automatically Better process control by automatically adjusting the air pressure and air velocity per adjusting the air pressure and air velocity per section. section.

Sterilizing/Depyrogenation tunnels Sterilizing/Depyrogenation tunnels consist of three chambersconsist 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

Ampoules Entry (HEPA Filtered zone)

Ampoules Washing

Ampoules Heating 250°C(sterilization +

depyrogenation)

Entry zone Cool zoneHot zone

AIR

Ampoules Zone @ 250°

Tunnel Tunnel in the linein the line

Sterilizable Cooling Chamber

Cooling Chamber, Heating Elements

The depyrogenating tunnels with sterilizable coolingchamber 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.

Automatic Tight Door

Automatic Discharge Of Final Vials

Automatic Discharge Bar

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.