Fully Automatic Clean Room Robot Based Pre Fillable Syringe Filling and Plungering Machine with 100% In Process Checkweighing System

Fully Automatic Clean Room Robot Based Pre Fillable Syringe Filling and Plungering Machine with 100% In Process Checkweighing System

Models: APFS-2H-IPC and APFS-5H-IPC

When it comes to filling and plungering of RTU (Ready to use) PFS, it becomes a pivotal operation in case of 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 Checkweighing System. Specialised Robots performs all handling activities starting from Tub opening and Tyvek removing to final placement of filled and plungered PFS nest back into the Tub.

The filling operation can be propelled by imported high accuracy rotary syringes 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 system along with 21 CFR part 11 Scada system.
 

Product Details

Technical Specifications

Salient Features

  • 100% In-Process Checkweighing with imported High Precision Load Cells.
  • Staubli Clean Room Robot for Filling, Weighing and Plungering Operation.
  • Fully Automatic Staubli Cean Room Robot based Tub Opener system with Tyvek Remover.
  • Simple stand-alone design ensures Laminar Air Flow and Maintains Sterility during filling and stoppering process.
  • CGMP and USFDA Compliant.
  • All direct contact parts with Filling & Stoppering processes made of SS316L material.
  • All non-contact of SS304. (structure of the machine)
  • Filling & Stoppering components are 100% “AUTOCLAVABLE”.
  • Suitable for 64 / 100 / 160 nested pre fill syringes & bagged plungers.
  • Filling with high precision seal-less ROTARY PISTON SYRINGE PUMP.
  • No NEST – No Filling interlock arrangement.
  • Complete Servo driven systems 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 for Nest transfer.
  • Security interlocks for all opening doors for machine stop system.

Optional Accessories

  • Load Cell based Buffer Tank.
  • Industrial PC with 21CFR part 11 compliance. (SCADA System)
  • Laminar Air Flow System for sterile atmosphere used for processing according to clean room Class-100 area.