• INTERTECH TECHNOLOGIES PVT. LTD.
Engineers to Healthcare Industry®
Vial washing, sterilization, filling, stoppering, and capping line
   

INTERTECH offers customized plant construction for the pharmaceutical injectable industry demand of Washing, Sterilizing , Filling & Closing line. A set of machineries are synchronized for the processing of vials. Compact installations are particularly economical and flexible in respect of format and product change over. The space saving and energy saving compact installation are clearly laid out and easy to operate with saving in number of operators, less personnel movement in the classified area.  The equipment specification conform to quality guidelines GAMP4 and supports 21 CFR PART 11 requirements.

 


 

We offer following Compact Sterile DrY Powder Vials Processing Line:

Dry Powder Vial Compact line 300
Dry Powder Vial Compact line 200
Dry Powder Vial Compact line 150

The entire line consists of linkage of Vertical Washing Machine, Sterilization Tunnel & Filling and Closing  Machine.  All linkage accessories along with filtration skid for water, Laminar Air Flow are also supplied along with complete line.


VIAL WASHING MACHINE



Vials Washing Process: Vials Working Description:
  • Ultrasonic treatment (optional)
  • Recycled water (internal and external)
  • Compressed air (internal)
  • Purified water (internal)
  • Compressed air (internal)
  • WF1 (internal)
  • Compressed air (internal)
Vials can be fed on to an in feed conveyor or alternatively a turntable from where they are fed to a star-wheel and delivered to a revolving conveying system consisting of 40 or 60 grippers equally spaced. V-grippers are mounted o the circumference of the gripper ring, which rotates around a vertical axis. The horizontal rotation of the vial through 180˚ during the in feed as well as the opening and closing of the grippers is cam-controlled. Vials are passed through the cleaning station upside down. At the individual stations, spray tubes travel is synchronized with vials, then enter the vials whose orifices are exactly centered. The spray tubes follow the continuously moving grippers from the start to the finish of a working station and retract.


  Max diameter
Nos./min
Max height Capacity Grippers
Vials sizes 25 45 300 60
38 61 200 60
25 45 200 40
53 97 120 40
25 60 120 26
44 73 80 26

SALIENT FEATURES

  • All parts that come in contact with the internal surface of the ampoule/ vial and wash media are made of AISI SS 316L stainless steel.
  • Other parts are made from engineering plastics, FDA approved or AISI SS 304 stainless steel.
  •  The washing process can be customized to your requirement. Each vial or ampoule is guided through a series of process steps.
  • Short set up time, fast & simple size change ensures versatility of use for different ampoule/vial
  • All electronically controlled features of machine can be equipped through PLC with operational data logging system for the documentation of all data relevant to the production
VIAL STERILIZATION & DE-PYROGENTAION TUNNEL


De-pyrogenation tunnels designed to sterilize and de-pyrogenate glass containers with a continuous process maintaining an ISO 5 environment along the whole length and width of the conveyor belt complying with ISO 14644-1 requirements.
Designed to allow higher outputs in a more compact body and with better control of the process. INTERTECH tunnels are equipped with

  • Cooling system for the cooling zone.
  • Sterilizing of the cooling zone.
  • Automatic air balancing between aseptic and non-aseptic area of the tunnel.
  • Shutter positioning monitoring and automatic adjustment are some of the options available to meet specific customer requirements.

TECHNICAL PARAMETERS

  • Sterilizing Temperature – 350 Deg C
  • Sterilizing Time – 5min to 7 min
  • Net stripe speed – 50-250 mm/min
  • Cleanness grade & method – 100 class with vertical laminar flow
  • Speed – 100 to 300 Ampoules /min.
Technical Specifications
  DST 300 DST 400 DST 450 DST 600 DST 900 DST 1200
Length 2700 3315 2800 2800 3900 4200
Height 2400 2400 2400 2400 2400 2400
Width 1300 1400 1400 1450 1550 2150
Belt width 300 400 400 450 600 1200
Exhaust Air-m3/hr 1347 1845 1845 1244 4448 8227
Installed Power(kw) 38 45 45 29 55 95

SALIENT FEATURES

  • Each independent filter plenum is provided with filter integrity sample ports.
  • The equipment’s conveyor net is monitored and alarm status is activated if it operates outside the belt speed set points.
  • Provision for ports to allow introduction of validation thermocouples in each zone
  • The tunnel is provided with fully integrated vial flow control logic to allow automatic stops and restarts of the equipment.
  • All filter modules have differential pressure gauges to monitor pressure. Pressure switches with high and low alarms
  • When the tunnel is not in use it can be operated in night-mode to save energy while preventing contamination.
  • The air quantity in whole machine can be set to auto section frequency- conversion balance.
  • All critical parameters i.e. temp., Fan speed etc. has auto recording facility.
    
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DRY POWDER VIAL  FILLING, STOPPERING & CLOSING MACHINE


VIALS FILLING & STOPPERING MACHINE MONO BLOCK DESIGN - AUGER FILLER
 

All Parts in contact with filling media are of SS316 L AISI 316L material A turntable and a one to two lane in feed belt feed the containers into the conveying system.

PRINCIPLE OF OPERATION 
The product on the powder supply chamber is kept in constant motion with the help of an individual agitator, with programmable speed. The powder is transferred to an intermediate chamber also with its own agitator. The powder is taken by vacuum into the dosing wheel, which indexes and dosed with sterile compressed air into the container. After each dosage, the dosing chamber is purged with additional sterile compressed air. Filled vials are carried to the stoppering station. As with all parts that come into contact with the product, the dosing wheel can be easily cleaned and sterilized.

CONTINUOUS AUTOMATIC DOSING ADJUSTMENT
Dosing port are automatically adjusted during operation in accordance with feedback from the weighing cells. The dosing ports can be adjusted from the control panel without opening the machine cabinet. After automatic check weighing system and 100% at start up, monitors the dosing weight at individual stations and adjusts the weights of trend in weight change is determined. The whole process is data logged. Containers with weights out of range and unstopped vials are rejected out of the system by a vacuum assisted star wheel.

STOPPERING STATION
To minimize the risks of particles, the rubber stoppers are picked-up by vacuum from a vertical plane away from the containers and with a rocker arm plunger, placed onto the vial. This system operates by vacuum / compressed air principle. The system processes an extraordinarily broad spectrum of powders, dust free and with great precision, owing to the very small and easily manageable design changeover.

Filling volumes
Filling Vial Vial opening D=8 mm Vial opening D=12.5 mm Vial opening D=20mm
Filling Shot
  5.9 mm 10 mm 18 mm
Range of Filling in 1 filling 0.07-0.43 0.40-3.0 3.0-9.6
Cubic centimeter 2 filling 0.14-0.86 0.80-6.0 6.0-19.20
  3 filling 0.21-1.29 1.20-9.0 9.0-28.8
  4 filling 0.28-1.72 1.60-12.0 12.0-38.4


TECHNICAL DETAILS

Technical data IET 150 IET 300
Output 150/min (1 dosing wheel) 300/min (2 dosing wheel)
Vial dimensions D=20-52 mm, H=35-120 mm  
Min dosage 50 mg  
Max dosage 8 (manual drive) Infinite (servo drive)
Pistons/ wheel 12  
Weight Control Inline- statistical weight control and 100 %  
  Weight control during start up  
Plug Size 20 mm  
Installed power 4 Kw 6 Kw
Compressed Air 120 ht/min (7 kg/cm2) 240 ht/min (7 kg/cm2)
Dry vacuum 40 m3/hr 80 m3/hr
Net weight 1 200 kg 1 800 kg
Gross Weight 1 400 kg 2 100 kg



VIALS FILLING & STOPPERING MACHINE MONO BLOCK DESIGN - VACUUM FILLER
 

DESCRIPTIONS
INTERTECH Converted proven concept of vacuum drawing & flushing of powder by compressed air from Semi Automatic & Fully Automatic to avoid manual handling of Container and achieving higher speed without loosing conceptual high degree of accuracy for uniform density injectable powders.

PRINCIPLE OF OPERATION
This sterile powder of granules placed in the Powder is thoroughly agitated by a pair of Agitators of maintain uniform bulk density of powder before it is drawn by vacuum   into of Powder wheel. The Powder Wheel having total sixteen ports i.e. Eight ports in two rows. During the vacuum port of the rotating Powder Wheels draw the correct volume of powder in indexes further where the excess powder is doctored off. The powder remains in the due to the vacuum till the indexed port of the powder wheel reaches in the vertical position.

Containers feed on to the Un-Scrambler is continually transferred in two row to the conveyor, where Vial Separators holds the Vial perfectly below the port of the powder wheel. Now the timed dose of the low pressure sterile air/inert gas empties powder in to the automatically positioned container from the port of powder wheel. The Vial separator now released the container on the conveyor. The filled container moves further and submerged in single row for rubber stoppering operation.
 
The stored, sterilized, siliconised and Rubber Stoppers in the Rubber Stopper Hopper are made to pass through mechanical orientation system. The moving container is held firmly by two Timing Belts for correct pick up of rubber stopper from the outlet of the chute. Further container is passed beneath two Pressing Rollers for tight fit fixing of rubber stopper. Moving containers are now transferred and accumulated on the Scrambler
for further operation.

SALIENT FEATURES

  • All the parts and the assemblies coming in the contact with the Powder and the mandatory Sterilization / Autoclaving.
  • The Unit can be easily placed under the Laminar Flow.
  • High degree of accuracy of +1 % can be achieved for most free flowing powders of uniform density at controlled relative humidity level.
  • Multiple Dosing of injectable Powder or change over of container size and different fill size is possible by just changing the container separator or the size of the Piston respectively.
  • The Port of the Powder Wheel i.e. Fill size can be very easily set or changed with the different size of piston.
  • No Container, No Fill system eliminates wastage of costing Powder.
  • The Unit is provided with a neat Control Panel, Gauges and Pressure Adjustment knob for observing smooth standard operation Procedure.
Technical Specifications
OUTPUT Up to 250 fills / minute for single dose (Single powder Wheel)
Up to 250 fills / minute for double dose (Double powder Wheels)
FILL CAPACITY 50 mg. to 6 gms. Single , Double and Triple Dose with the help of different
Powder Wheels and depending on the neck diameter of the container.
ACCURACY ± 1% for uniform density free flowing powder at controlled humidity level
below 30%
POWER RATING 380/440 Volts, 3 Phase ,4 wire system.
1,0 HP for Machine
0.5 HP for Un-Scrambler
0.5 HP for Scrambler
0.5 HP for Rubber Stoppring Unit
0.5 HP Single Phase Gear Motor for Pressing Roller.
Dimension 3515mm (L) x 1115 mm (W) x 1800mm (H)

SPECIFICATION OF INPUT
CONTAINER      

25 mm TO 40 mm

HEIGHT          75 mm Maximum
RUBBER STOPPER DIAMETER  20 mm
PNEUMATIC LINE

Filtered, Oil free sterile Low Pressure Air or Inert Gas at 2 kg.  cm 2
pressure (8x9 cfm)

VACCUM LINE 800 Hg (9/10 CFM)

CAP SEALING MACHINE

WORKING PRINCIPLE

Leading edge technology in compliance with cGMP design criteria. Perfect understanding of the needs of our customer, blossoms in to a product of high quality and performance from engineering and manufacturing to commissioning at customer plants.The time tested principle based on individual self rotating rollers that pivot into each container rim thus creating a low particle high quality seal. Operation of the machine is easy and simple. Accessibility for cleaning and maintenance is excellent.. Size changeover is fast, easy and reproducible with the help of digital position indicators.

CHECK DEVICE

  1. Containers detection of the in feed
  2. No stoppers – no cap
  3. Low level cap feed
  4. Serial fault monitoring display
  5. Torque limiter for in feed and out feed turret

OPERATION

Bunged vials are fed by a turntable or a conveyor to the in-feed slotted wheel. The in-feed wheel feeds the spaced vials to the sealing turret. Simultaneously to this action the vial collects a cap each from the end of a cap feed chute and imparts it in a proper orientation for the sealing. The sealing turret consists of eight sealing heads which are identical. These eight sealing heads skirt, spin and seal the cap onto the neck of the vial.

TECHNICAL DETAILS

  Diameter Height Capacity
IET 4 16-86 mm 35-180 mm 150 (for smallest range)
IET 8 16-52 mm 35- 105 mm 300 (for smallest range)
IET 6 16- 70 mm 35-140 mm 200 9for smallest range)

Vial Sizes D 14.5 mm to 80mm
Cap sizes H 13.20 mm to 30 mm
Output Speed 100 to 300 Vials/min


Voltage 200 V, AC Supply for vibrator
415 / 380 V, 50 Hz, 3 Phase
AC Supply for machine
Main drive 1.5 HP
Dimension 955x1015x1700 (LxWxH)


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