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An ISO 9001:2000 Company
 
 
Manufacturer and Exporter of Injectable Dry Powder Filling with Vial Liquid Filling Rubber Stoppering Machine.
 

Liquid Filling Section
 

Automatic pre filled Syringe filling and Stoppering machine- PFS-SA-10
 
Injectable Dry Powder Filling with Vial Liquid Filling Rubber Stoppering Machine
 
Model –PFS-SA-10 is very compact and elegant PLC. Based cGMP model for automatic filling and Stoppering operation of pre filled syringe.
 
Operation :
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 ‘.

THEN
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
 
Cycle Operation
  • Pre  Evacuation in the chamber
  • Nitrogen flushing.
  • Vacuum  Evacuation in the chamber
  • Nitrogen flushing.
  • Vacuum Evacuation repeats.
  • Nitrogen flushing repeats.
  • Vacuum creation with hold.
  • Plunging of stoppers inside the pre-filled syringes
  • Nitrogen purging cycle with Vacuum break.
 
Salientfeatures
  • 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.
 
IMPORTANT REQUIREMENTS.
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.
 
Machine Specifications
Model No. PFS-SA-10.
Out put 2600 to 7200 Syringe/hours.
Filling ht. 775 – 825mm adjustable.
Electrical rating: 4.1.   230v. 50 Hz 4.2.  2HP, 3 Phases, 440V. 50Hz.
Overall dimensions: 5.1 length : 1200mm
5.2 Width : 750mm
5.3. Height : 1200mm
   
 
       
Volumetric dosing with valvess rotary piston pumps   processing vials   Word station of the filling and closing machine with semi automatic nest loading   All product contacting parts are made out of AISI36L   Filling and stopper insertion station. The Plunger Stoppers are positioned precisely without exerting pressure on the product.
 

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.
 
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Liquid Filling Machine MODELS
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Automatic Four Head Liquid Filling with Rubber Stoppering Machine for Vials SBVFS 120
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Automatic Eight Head Twin Track Liquid Filling with Rubber Stoppering Machine for Vials SBVFS 250
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Automatic Four Head Liquid Filling Machine for Vials SBVFS 120
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Automatic pre filled Syringe filling and Stoppering machine PFS-SA-10
 
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