Vial Sterilization Tunnel

Product Description

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.

  • Salient Feature
  • Add On Feature
  • Applicable Industries

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
  • 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.
  • Pharmaceuticals
  • Injectable

Notes:

  • Right Of Technical Enhancement & Modifications Reserved.
  • All Illustrations & Dimensions Are Described For Information Only
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