“Ambica®” Fully Automatic Pre – Fillable Syringe Filling And Fully Automatic Plungering (Stoppering) Machine Model: APFS-5H Machine Operation: The Fully Automatic Pre – Fillable Syringe Filling And Fully Automatic Plungering (Stoppering) Machine is designed to Fill Injectable liquid with small fill volume in different sizes of Glass Syringes and stoppered the same with the help of servo driven pick and place system, in X, Y and Z axis operation. Input Specifications : Handling Pre Filled Syringes in Tub – Nos. / Tub 42-64-100-160 PFS Nest or any other specific Handling Rubber Stoppers Size / Type Siliconized, Butyl as per the suitability of the PFS Basic Machine Suitable for 1 ml to 3 ml standard length and Diameter Pre Filled Syringes with the help of Change parts. Filling Range 0.2 ml – 10 ml. Output Capacity (Speed) Upto 75 PFS/min @ 1ml *Actual Speed Subject to Product to be filled and size and quality of the container to be filled Basic Machine Preset with:  cGMP Model  PLC with 10” Colour Touch Screen HMI  Multi Axis Servo driven controls  Servo Driven Pick and Place System for Plungers  Completely Multi Axis Servo Control through Motion Controller  Vacuum Pump for nest transfer  Change Parts Suitable for 1 ml to 3 ml standard Pre – Fill Syringe  Change Parts Suitable for 1 ml to 3 ml standard Stoppers.  1 ml to 3 ml Fill Capacity High Precision Rotary Piston Pumps(#12)  Toughened Glass Safety Cabinet with 5 Nos. Glove port with Gloves Salient Features:  Simple stand-alone design ensures Laminar Air Flow and Maintains Sterility during filling and stoppering process.  CGMP Compliant.  5 Heads Filling with 5 Heads Plungering.  Synchronized Operation through PLC and HMI.  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 42 / 64 / 100 / 160 nested pre fill syringes & bagged plungers with the help of change parts.  Filling with high precision seal-less ROTARY PISTON PUMPS.  Fully automatic PFS holding tray from filling to stoppering station  No NEST – No Filling interlock arrangement.  Tube Vent (Pipe in – Pipe out) Stoppering system as a standard viscosity liquids.  Pre and Post Nitrogen Purging system.  Complete Servo driven systems for high accuracy.  Multi Axis Motion Controller with Touch Screen enabled operational system.  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.  Dedicated Stoppers Loading station with linear and rotary vibrator bowl and elegantly placed stopper loading system.  Inbuilt vacuum pump for Nest transfer  Robotic type tub Pick & Place System prior to filling & after filling process.  Security interlocks for all opening doors for machine stop system.  High precision “X-Y” table for accurate filling and stoppering operation  Laminar Air Flow System for sterile atmosphere used for processing according to clean room Class-100 area. (Optional)  Load Cell based Liquid tank for Level control of Liquid (optional) Interlocks & Alarms:  Low Air – Machine Stop System.  Low Vacuum – Machine Stop System.  Cabinet Door Open – Machine Stop System.  No Tub – No Filling – No Stoppering System.  Low Level of Rubber Stoppers – Machine Stop System.  Servo Overload – Machine Stop System.  Low Level of Liquid in Load Cell based Tank – Machine Stop System (Optional)  SCADA system - 21CFR part 11 (optional)  Tub Opener System (optional)  Automatic Tyvek paper Remover (optional)  LAF Pressure Low interlock – Machine Stop System. (Optional) Machine Dimensional Details:  2200mm (L) X 1200mm (W) X 1950mm (H) ± 50mm Utilities Required:  Power: 8kw, 1 Phase, 230V AC at 50Hz for machine & 1kw, 3 Phase, 415V AC at 50Hz for Vacuum Pump.  Compressed Air : 5BAR, 4-5CFM (STERILE)  Vacuum : 300 LPM  Nitrogen : 2BAR, 1-2 LPM(IF NEEDED)