Automatic Pre Filled Syringe Filling & Stoppering Machine – PFS-SA-10
Pre Filled Syringe Filling & 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.
We have developed machine model PFS-SA-10 for meeting constantly increasing production requirements of pre-filled syringes. This high-tech filling and stoppering machine for syringes is not only compact and flexible, but also delivers required production speed up to 12000 pieces/hour. Besides, it also offers high precision in dosing operations and a complete protection of syringes.
This modular machine can be equipped with 2 to 5 stoppering/filling stations, hence it is suitable for low speed as well as high speed. Moreover, it is possible to modify these features with further transformations.
As a result of its special design of the work areas, this machine can be easily integrated in different possible layouts. We have given special attention to design moving parts, preferring the usage of linear drive shafts or rotary drive shafts with open wheel to ensure the cleanliness of the machine and for the integration of RABS or isolators.
It offers perfect machine ergonomics and controls arrangement to easily integrate the material dispensing and handling systems in compliance with the directives concerning the assembly of parts in contact with the product.
We offer an advanced machine program for the filing and packaging of sterile liquids and powders. The filling can be in vials, infusion bottles, disposable syringes and carpules. Moreover, the isolators for sterile filling of liquids, powders along with the freeze dry systems to extend the shelf life supports the portfolio.
Functions and feature of Prefilled Syringe Loading Machine & Light Inspection Machine
- Load syringe tubs by hand, automatically den-ester with syringe from the tub,Automatically loading the filled and closed syringes to the machine.
- The filled and closed syringes rotate automatically, the visual inspection is to be Done under a magnifying glass, the unqualified syringes is to be kicked out.
- It can equip with LAF hood.
- This machine can be used as a individual machine, and can also form a multi functional production line. In the production line, before this machine is
- pre-filling syringes filling and capping machine, after this machine is pre-filling syringe rod screwing labeling machine.
Application : Visual inspection of ampoules, vials, pre-filled syringes, infusion bottles, etc.
Main technical parameter
|Compressed air||0.55-0.75 Mpa 20L/S|
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
- 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.
- 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.
- 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.