Fully Automatic Multi-Axis Servo Driven Pre – Fillable Syringe Filling and Plungering (Stoppering) Machines

Fully Automatic Multi-Axis Servo Driven Pre – Fillable Syringe Filling and Plungering (Stoppering) Machines

Models: APFS-2H and APFS-5H

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. The machine we present is advance motion controller based filling and plungering machine with servo drives. 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

  • 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)
  • Fully automatic Servo Driven Tub opener system and Tyvek paper remover Machine.
  • Semi-Automatic PFS tub bag cutting and manual loading system with SS frame Structure and fixed glass doors.
  • Laminar Air Flow System for sterile atmosphere used for processing according to clean room Class-100 area.