Vial Sterilization Tunnel

N.K Industries ‘s ISO class 5 continuous Sterilization Tunnel is basically a fully automated system which utilizes dry heat by means of forced convection of filtered air through high efficiency particulate air filter to achieve sterilization of washed empty pharmaceutical glasswares used for parenterals product packaging. N.K Industries ‘s continuous dry heat Sterilization Tunnel ensures glassware is exposed to depyrogenation temperature for time required for the necessary reduction in endotoxins which at bare minimun is > log 3 at rated output.

N.K Industries continuous dry heat Sterilization Tunnel can be used as a standalone unit or can be supplied configured for easy integration with washing machine at its upstream side and filling - sealing machine at its downstream side thereby forming high speed - high yield parenteral product packaging line.

The forced conventional dry Sterilization Tunnel consists of Drying Zone to evaporate the wash water from glassware. The sterilizing Zone sterilizes the glassware at 300 ⁰c (apprx). And the third section consists of cooling and sterilizing zone to restore the glassware temperature to ambient.

Sailent Feature

DRYING ZONE COMPRISES OF:

The Forced Conventional Dry Sterilizer Consists Of Drying Zone/ Preheat Zone To Evaporate The Wash Water From The Glassware.

The Basic Units In This Zone Are As Follows:

EU – 7 Grade Prefilter
Motor - Blower Assembly
EU – 13 Grade Minipleat Final Filter Utilizing State – Of – Art Hot Melt Technology.
Mechanical Differential Pressure Guage (at Extra Cost) (magnehelic) To Monitor Pressure Drop Across Final Filter With Respect To Ambient As Standard Option Available Is Photohelic Which Gives Impulse To Audio Visual Alarm System When Differential Pressure Drops Below Or Increases The Preset Values Across The Final Filter.
Vapour Extract Motor Blower Underneath Conveyor With Exhaust Duct.
S. S. Drag Shield With Polycarbonate Inspection Window Which Is Integral Part Of Drag
Shield.
Integrated PT 100 (simplex) Temperature Sensor(at Extra Cost) Provided To Monitor Temperature In The Zone For Displaying Purpose.

STERILIZING ZONE COMPRISES OF

The Basic Function Of The Sterilizing Zone Is To Sterilize The Glassware At 300 0c (apprx).It Is A Double wall asbestos free ceramic wool insulated recirculatory module containing The Following Parts :

High Temperature EU – 13 Grade Final HEPA Filter With Suck-back Mechanism Suitable For 350°c Continuous Repeated Cycle.
Turbine Driven By 3ø Induction Motor Through V-belt Drive.
Heating Of The Air Is Through U Type Tubular Heater Encased In S. S. 304.
Sterilization Of Vials / Ampoules Is By Heated Air Which Is Filtered Through High Temperature HEPA Filter.
Hot Filtered Air Is Recirculated In This Zone At A Speed Of Approximately 0.7 M / Sec Which Sweeps Container From Top To Bottom And Temperature Remains Within 5°c Of Its Set Point.
Glass Vials / Ampoules Are Safely Exposed To Temperature Of 350°c.
Integrated Temperature Sensors Are Provided For Monitoring And Controlling Of The Temperature Inside The Sterilizing Zone. For This Purpose One Duplex Sensor Is Placed Above The Hot HEPA Filter And The Other Sensor Is Placed At Entry Side Of The Sterilizing Zone. For Extra Precaution In Case Of Over Heating A Thermostat (0 – 500°c) Is Used For Protection Of Heaters.
The Entry And Exit To The Sterilizing Zone Generally Consists of Manually Adjustable Profile Plates Resulting In Better Control Of Air Pressure And Air Velocity Resulting In Maximum Temperature Uniformity And Ensure Consistent Result For Glassware With Varying Sizes.
Extreme High Temperature Exposure To Vials / Ampoules Should Be Avoided As It Can Result In Change Of External Surface Which May Adversely Affect Downstream Handling. Hence Normal Operating Temperature Is Kept Around 350°c.
Mechanical Differential Pressure Guage(at Extra Cost) (magnehelic) To Monitor Pressure Drop Across Final Filter With Respect To Ambient As Standard Option Available Is Photohelic Which Gives Impulse To Audio Visual Alarm System When Differential Pressure Drops Below Or Increases The Preset Values Across Final Filter.

COOLING / STABILIZING ZONE:

And The Third Section Consists Of Cooling And Stabilizing Zone To Restore The Glassware Temperature To Ambient. It Is A S. S. 304 Modules Containing The Following Parts:

EU – 7 Grade Prefilter.
Motor - Blower Assemblies.
EU – 13 Grade Minipleat Final Filter Utilizing State – Of – Art Hot Melt Technology.
Mechanical Differential Pressure Guage (magnehelic) (at Extra Cost) To Monitor Pressure Drop Across Final Filter With Respect To Ambient As Standard Option Available Is Photohelic Which Gives Impulse To Audio Visual Alarm System When Differential Pressure Drops Below Or Increases The Preset Values Across Final Filter.
Extract Blower Are Provided Underneath Conveyor For Cooling And Stabilizing Zone With Discharge Duct Which Is Integrated With Vapour Extract Exhaust Duct From Drying / Preheat Zone.
S. S. Drag Shield With Polycarbonate Inspection Window Which Is Integral Part Of Drag Shield.
Vials / Ampoules Are Subjected To Significant Thermal Stress As They Move From Sterilizing Zone To Cooling Zone Which May Cause Cracking Or Impulsion. The Air Flow Is Profiled In Such A Way That The Glass Temperature As It Exits Sterilizing Zone Would Be Transitioned In A Nearly Linear Way.

ELECTRICAL AND INSTRUMENT CONTROLS:

PLC Based Operating Panel Is At Extra Cost
Stand Alone AISI 304 Control Panel Containing Allen-Bradley Or Any Other Reputed Make PLC With Panel View Plus Provide Controls Storing And Printing Out Data.
Animation Type Colour Touch Screen Display.
Integrated Temperature Interface Controller And Transmitter
Proximity Sensors And Integrated Temperature Sensors (at Extra Cost) Are Used To Provide
The Control Of In Feed Of Vials / Ampoules Adequate Temperature And Maximum Accumulation Of Out Feed With Conveyor Belt Speed.
A Temperature Interfaced Controlled Is Also Provided In The System For Displaying Sterilizing Zone Temperature.
Epron Facility In Plc Module.
Serial Port In Plc For Interface With Data Logger As Well As Temperature Recorder.
Integration Of Control Panel With Tunnel Is Standard Execution.

Other Features:

Proximity Sensor: If There Is Infeed And Out Feed Overload.
Acrylic Window For Production Observation On Both Sides Of Drying Zone, Cooling Zone And Stabilizing Zones.
Diaphragm For Separation Of Sterile And Non Sterile Area.
In Feed And Out Feed Dead Plate.
Mechanical Spring Loaded For Conveyer Tension Balancing System.
Conveyer Idler Roller Support At Six Different Points For Guiding Of Conveyer.
Turbine Motor Will Stop When The Heater Stops , This Operation Is Carried Out By Microswitch

Addon Features:

An On-line Printer Interface (at Extra Cost) With Plc.
Integrated PT 100 (simplex) Temperature Sensor(at Extra Cost) Provided To Monitor Temperature In The Zone For Displaying Purpose.