Fully Automatic Clean Room Robot Based Pre-Fillable Syringe Filling and Plungering Machines with 100% In Process Check Weighing System. Models: GNXPFS-2H-IPC and GNXPFS-5H-IPC
Fully Automatic Clean Room Robot Based Pre-Fillable Syringe Filling and Plungering Machines with 100% In Process Check Weighing System. Models: GNXPFS-2H-IPC and GNXPFS-5H-IPC
When it comes to filling and plungering of RTU (Ready to use) PFS, it becomes a pivotal operation in case of handling the PFS, maintaining the sterility, filling accuracy and closing precision and thats where clean room robots comes into the picture.
The machine we present is Staubli 6 – Axis Clean Room Robots based PFS filling and plungering machine with 100% In-Process Vial Check Weighing System. Specialised robots performs all vital activities starting from tub opening and tyvek removing to final placement of filled and plungered PFS nest back into the nest.
The filling operation can be propelled by high accuracy rotary piston pumps or peristaltic pumps, depending upon the nature of product and client’s requirement. Servo driven pick and place type plungering operation is done by pipe in – pipe out (tube vent) basis in case of aqueous liquid and vacuum assisted plungering is done when the liquid is viscous.
The machine we offer has Open RABS (Restricted Access Barrier System), we can also provide it in Closed RABS and Isolator along with 21 CFR part 11 compliance SCADA system.
High speed 100/200/300
Servo PLC based Operation
Accurate label placement
No change parts requirement
Very less down time for change over
One Touch Speed Synchronization
No. of Filling and Plungering Heads
2
Tub Opening Mechanism
Clean Room Robot Based
PFS Handling Mechanism
Clean Room Robot Based
Handling Pre-Filled Syringes Size
0.5 ml – 10 ml
Handling Pre-Filled Syringes in Tub – No. / Tub Size
64-100-160 PFS Nest or any other specific
Handling Rubber Stoppers Size / Type
Siliconized, butyl in bagged form
Filling Range
0.1 ml – 10 ml
Machine Dimensions
2300 mm (L) X 3550 mm (W) X 1900 mm (H) (Approx.)
No. of Filling and Plungering Heads
5
Tub Opening Mechanism
Clean Room Robot Based
PFS Handling Mechanism
Clean Room Robot Based
Handling Pre-Filled Syringes Size
0.5 ml – 10 ml
Handling Pre-Filled Syringes in Tub – No. / Tub Size
64-100-160 PFS Nest or any other specific
Handling Rubber Stoppers Size / Type
Siliconized, butyl in bagged form
Filling Range
0.1 ml – 10 ml
Machine Dimensions
2300 mm (L) X 3550 mm (W) X 1900 mm (H) (Approx.)
Salient Features
- Staubli 6 – Axis Clean Room Robot based tub opening and tyvek paper removing system
- Staubli 6 – Axis Clean Room Robot for PFS handling during filling, weighing and plungering operation
- Statistical or 100% In-process vial check weighing system
- High precision imported SS 316L or ceramic rotary piston pumps for filling can be offered as per customer’s requirement
- FDA 21 CFR Part 11 compliance SCADA system with high end industrial PC
- Optional vacuum assisted plungering for viscous liquid
- Simple stand-alone design ensures laminar air flow and maintains sterility during tub opening, filling and stoppering process
- USFDA and CGMP compliant
- All direct contact parts with filling & stoppering processes are made of SS316L material
- All non-contact of SS304
- Filling & Stoppering components are 100% autoclavable
- Filling with high precision SS 316L seal-less rotary piston pumps
- Complete servo driven system for high accuracy
- Heavy duty structured frame to avoid any vibrations
- SS cabinet with toughened glass doors fitted with high precision enclosure. (ORABS)
- Glove ports placed ergonomically and customizable at different positions as per the lay-out approved by the end users, before assembly process
- Inbuilt vacuum pump
- Security interlocks for all opening doors for machine stop system.
Optional Accessories
- Laminar air flow system
- Loadcell based buffer tank