HM VFill Series Aseptic Vial Filler  Sterile Injectable Vial Filling & Sealing Monoblock Machine
HM VFill Series Aseptic Vial Filler Sterile Injectable Vial Filling & Sealing Monoblock Machine
Submit the product Inquiry list

Product details

HM VFill Series Aseptic Vial Filler

Sterile Injectable Vial Filling & Sealing Monoblock Machine

  


This machine is Advanced automatic injectable vial sterile liquid filling,  stoppering and cap sealing monoblock machine,  especially for injectable aseptic liquid products in glass or plastic vial 2-100ml, or custom made 50-500ml.  It has advanced aseptic design and compact mono-block structure, comply with international cGMP and European CE standard, also USA FDA 21CFR part 11 compliance available.


                                  

Main Salient Features:

Aseptic sanitary design,  rational structure, easy for operation and cleaning,  meet the requirement of cGMP regulation.


All in one mono-block machine with liquid filling, stopper plugging and cap crimping.

Loading vial, star-wheel to feed bottle, filling liquid, stopper hopper for feeding stopper, plugging stoppers, cap hopper for feeding cap, crimp capping and discharge to tray loading will be done by one machine, high efficient working.

The application of this machine is wide range, and it is suitable for different sizes of vials, such as 2-100ml vial size.

Fast change over design. Vial size parts change over are easily and conveniently done.

 Stopper size parts and cap size parts are also easily change over and adjustable.

Using servo motor driving to feed bottle in the filling, stoppering and capping station, the high precise index controls the bottle in proper position. No gears, chains, driving belt etc transmission system, no pollution at all for the sterile zone.

Can setup speed and regulation through the HMI friendly.

Mono-block vial filling, stoppering and capping machine, combine the capping machine into the filling and stoppering machine together to save the clean room space.

European CE standard with safety guard cover.

Control system with High configuration SIEMENS PLC and touch screen HMI.

     Servo motor driving for filling in high precision.

     User friend interface for automatic operation.

Working parameters can be set and stored in the PLC.

     Regulation easy: input digital quantity to HMI setting directly, controls the filling dosage.

     Parameters and recipe will be saved and load on next startup.

High filling accuracy: filling liquid by high precision peristaltic pump with high precision servo motor controlling, suitable for filling injectable liquid in a high accuracy and reliability.

for better filling accuracy and easy filling volume change

 Filling with Diving nozzles, the nozzles will come inside vial for filling, filling is smooth without spill over and avoid foaming.

No vial no filling, no stoppering and no capping

Lack of vials, stoppers and cap, automatic alarms.

Meet with GMP regulation:  

MOC: Contact parts are high stainless steel 316L and food grade silicon-gel tube.

Non contact cover is stainless steel ss304 or other corrosion-resistant alloy.

Machine are in Full close working conditions. No pollution to the product or to the environment.  

      Easy Dismounting: modular peristaltic pump construction, soft tube and filling heads is sterile  and can be dismounted easily for cleaning.  

Easy Cleaning: working table-board parts are installed by high column and have sealing ring, which can be washed directly with water.

Suitable for lyophilized product half stoppering, and liquid vial full stoppering.

Adopt sanitary jaw type or single-blade crimp sealing system, suitable for both  alu cap and  alu-plastic flip-off cap.

Also avoid alu particle generation and flying.

                                                                                

Automatic Counting the output quantity.

 It can work independently for sterile packed vials, also can be optional linked with vial washing machine, de-pyrogen sterilization tunnel, form a complete vial filling line.


General Description of the machines

Operation height: 850+/-20 mm

Electricity Connection 380V, 50Hz, 3phases

Cable Wiring: Cable marking is included with identifier characters

Material: stainless steel, anodized aluminum and appropriate plastic materials, if not mentioned otherwise if possible

Electrical cabinet: electrical cabinet in Stainless steel (SS304)

Human Machine Interface: SIEMENS Touch Screen

Control system SIEMENS PLC

Language :  All documents are in English language, if not mentioned

Design concept

Adopts the high standards of design concept, the independent structure is more suitable for modular ergonomic criteria, satisfied with the rationality of operator interface and user.

The main parts contact liquid material are made of 316L stainless steel and food grade silicon tube, other non-contact parts are made from sus304 stainless steel or POM or other material can satisfy the requirements of sterile and cleaning.

Using high precision peristaltic pump with servo motor controlling for filling sterile liquid, or piston pump etc filling system, it can dose of liquid constant in the containers with high accuracy.

Structural description

The frame covered by stainless steel.  The sides of protective plate used SS304.    

Cabinet is made of 304 stainless steel, connecting with the equipment.

The operating height is 850mm and regulating range is ±20mm.

Vials transmission

Vials in-feed from tray loader to the turntable, then come into the filling station by the star wheel, after it filled liquid and stoppering, it will go to the capping station and then go to the out-feed by the star wheel and pusher.

Filling system

The filling system has precision peristaltic pump, using servo-motor controlling. It can set and adjust the dosing volume by the HMI. The parts contact with medicine are made of 316L stainless steel or food grade silicon-gel tube which satisfy the sterile requirements.

The silicon-gel tube and filling nozzles can be removed cleaning and sterilization.

Stoppering system

The rubber stopper can automatically go into stoppering station after the vibration hopper.

Automatic manipulator Pick & Place system and Inserting the stopper into the bottle mouth to seal it smoothly.

The rubber stopper hopper made of polishing treatment stainless steel, can be removed, cleaning and disinfection.

Main Driving system

Main motor driving system, use Servo motor to driving the machine instead of standard motor driving system, speed can be setting and regulated from HMI touch screen.

It is intermittent type of machine,  the range of speed regulation is large, running precisely and stably, no falling vialsno broken vials.

There’s an emergency stop button under the user’s right hand.

 Vial Capping System:

Vial Capping system is suitable for sealing procedure of vial by aluminum cap and flip-off cap.

By single or double capping head with advantages of low damaged and attractive appearance.

The capping station is configured with a star-wheel for vial movement.  When the vial goes to the capping station, the capping head will come down to the vial mouth to complete capping.  

The material of capping heads is made of special alloy, which can increase the abrasion resistance.

Capping head mechanism can adjust the height to suitable for different size of vials.

The star wheel is made of high-quality POM with small friction coefficient.

Electrical  installation

Electrical equipment comply with current Electrical regulations(IEC).

Electrical supply voltage and hertz must be confirmed before.

Control Cabinet including the parts as follows:

One set of programmable logic controller PLCSIEMENS, logic control input and output.

One  touch Screen  SIEMENS or Mitsubishi brand, to display output, speed and fault.

Each motor overload protection and switch.

The sensor used to measure and control.

Monitoring and control system

Use the password’ setting to operate the equipment and set the parameters.

The main menu screen

   Including parameters setting, operating system, alarm records.

Parameters setting screen,

  IncludingWhen the output reached the setting, automatic tips and stop.

Operating system screen

  IncludingVial in-feed switch, stoppering switch, main switch, no vial no filling and no  stoppering switch, cap feeding switch, time display, the number of produced vials display.

Alarm records screen

    Display each failure occurring time and solving methods.

 

High standard Configuration List:

Material of construction MOC:

Contact parts with medicine solution: Filling nozzles is made from S.S. 316L

                                                             pharma and food grade silicon gel tubes.

Non contact parts: Table board, side cover plates, door frame are made from S.S. 304

Transferring chain: POM engineering plastic

Star-wheel:   PE or POM plastics

Safety guard cover door:  safety tempered glass or organic glass.

 High-class components:

        PLC: SIEMENS Germany

HMI touch screen: SIEMENS Germany

Frequency inverter: SIEMENS Germany

Main servo motor:  DELTA Taiwan

Relay, breaker etc low voltagesSchneider France or  Siemens Germany

Main pneumatic components:  SMC Japan.

        Sensors: Omron Japan etc.

 

Optional:

O-1. Extra vial size change parts for different vial

O-2. Extra stopper size change parts for different stopper size.

O-3. Extra cap size change parts for different cap type and cap size.

O-4. USA FDA 21 CFR PART 11 Compliance

Electrical record for production data, alarms.

Electrical signature.

Audit trials of history archives.

O-5. Fully Separate capping system from filling and stoppering station.

Different outlet tray for half stoppered uncapped vial, and full stoppered capped vials.


O-6. Nitrogen flushing for product protection.

Before filling liquid or After filling and before stoppering,

purge with nitrogen air to protect the  special liquid products which is required less oxygen contact.  

With nitrogen purge nozzles, gauges and flow regulator.

O-7. Aluminum particle sucking devices

There is a sucking groove at the capping station.

It  need to connect with the vacuum dust collector, sucking out of aluminum particles from capping.

The device can guarantee the clean environment of capping area.

Vacuum dust collector with 5m flexible hose is included.

O-8. Aseptic buffer stopper/cap hopper and feeding system

 Aseptic buffer stopper  hopper and feeding system,  under the LAF laminar air flow

Aseptic buffer cap hopper and feeding system, under the LAF laminar air flow



O-9. Designed with RABS system for gloves operation

open Restricted Access Barrier system,

Class A Laminar air flow above the filling machine.

The door made of tempered glass or organic glass,  equipped with electronic safety protection device.

LED lighting and switches.

H13/H14 HEPA filters with DOP/PAO test ports.

Pressure gauge display the differential pressure of HEPA filters.

Germany EBM or equality air blower fan

Air speed: 0.45±20%,   With air speed regulator

Air flow speed sensor and display.

With Gloves operation system

Prepare 3 particle counter ports, in order to connect inline particle counter 


O-10.  Automatic Rejection System

     There are sensor checking and rejection system if the vial missed stopper, missed cap, the defective vials will be rejected automatically.

 

O-11. Other user requirement specification URS, such as IQ / OQ validation package.

Liquid buffer storage tank before filling.

Dosing system for CIP / SIP conditions.  

Washing unit and sterilization tunnel for vials supplied in bulk.

Vacuum-assisted insertion of stoppers to reduce the presence of oxygen in headspace.

Monitoring and particle counting, etc according to customer requirement.

Main Technical Parameters:


Notes:  1.    Power supply is based on 3 phases, 380V, 50Hz and 1 phase 220V, 50HZ. 
(If local power supply or plug has any difference, customer should inform before order. We will amend according to customer’s requirements as an option.)
2. The parameters and configuration are basic data for your reference. There may be some difference or change according to customer’s URS or material’s characteristic and HM final design.

 

Online Services

  Tel:+61-3-95790098

   Mob:+61-431088696

 Email:hm.australia@hmbusiness.com

 WhatsApp:+61-431088696