Operator has to keep a nest (tray) of 100 pre filled syringes over the SS jig. Then he has to put a jig to filling magazine and start the machine to filled syringes.
Automatic filling cycle start in 10 steps with at a time 10 syringe will fill with help of perisatalistic pump or ‘valve lees syringe ‘.
Operator has to keep a nest (tray) of 100 pre-filled syringes over the SS jig. Then he has to put a plug tray with suitable stoppers over the SS-316 plug tray. Then after he has to close the evacuation and Stoppering chambers. Now he can start the machine.
Automatic Stoppering cycle start one by one as per the programmed Stoppering cycle mentioned as under. 100 stoppers are plugged into the pre-filled syringes precisely after vacuum hold cycle. Now last cycle of nitrogen flushing with vacuum break completes the Stoppering operation.
Program cycle for evacuation and Stoppering.
Pre Evacuation in the chamber
Vacuum Evacuation in the chamber
Vacuum Evacuation repeats.
Nitrogen flushing repeats.
Vacuum creation with hold.
Plunging of stoppers inside the pre-filled syringes
Nitrogen purging cycle with Vacuum break.
Specifications of Pre Filled Syringe Filling & Stoppering Machine
Volumetric dosing with valvess rotary piston pumps
All product contacting parts are made out of AISI36L
Word station of the filling and closing machine with semi automatic nest loading
Filling and stopper insertion station. The Plunger Stoppers are positioned precisely without exerting pressure on the product.
Syringe Filling Machine Model: PFS-SA-10 is a compact, elegant and Matt-finished encompassed with stainless Steel (SS-304)
Perfect synchronization of PLC based cycle, filling stroke valve less Syringes to fill volume for 0.2 ml to 5ml. (With help of change parts.)
Filling accuracy will be 0.02 ml in case of 0.2 ml & for others it will depend upon fill material & fill volume.
Compact and feather-touch MMI control panel for easy control of the machine Operation.
The machine is equipped with easily adjustable leveling legs so foundation is not required.
Nitrogen filter is provided pre-filter 0.5u. And final filter is 0.2u. Air ex. Is 0.2u?
Vacuum pump is to be provide by BHAGWATI Technopride Engg.
Utilities (To be Provided by Buyer)
Sterile air and nitrogen.
Vacuum pump is to be installed outside the sterile area.
Silicon tubes are under the scope of customer.
Water line is required for cooling of vacuum pump chambers.
Note: Laminar flow is required 1. 5 Meters. X 1. 0 meter. For filling and Stoppering M/C.
A company producing a lyophilized product packaged with reconstitution fluid for intramuscular injection considers marketing a prefilled syringe for the same indication, in the management of rheumatoid arthritis. The company must reformulate the molecule to a stable liquid. The route of administration will remain the same.
The container–closure device, however, will change, which means that some materials and the functionality of the system will be different. In addition, long-term storage conditions may change because of the new formulation.