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Temperature & Humidity Validation

Temperature & Relative Humidity Mapping perform as per standard guideline.

The Reporting formats consist of Diagram Indicating Sensor Locations, Mini. & Max. Temperature at all locations, Graphical Representation of Temperature Vs Time, Hot & Cold spot, Standard Deviation and Mean Kinetic Temperature (MKT).

Test Includes,

  • Cold Room
  • Clean Room & Production Areas
  • Stability Chambers
  • Cold Chambers / Refrigerator
  • De-progenation Ovens / Lab Ovens
  • Muffle Furnace
  • HPLC/GC Column Oven
  • Temperature & Humidity Chamber

BOD Incubator

deep freezer

Stotage Area

Hot Air Oven

Warehose Area

warehouse

Equipment Validation

CALITECH performed Validation with Latest 21 CFR compliance Data logger with software for F0 value calculation. Validation performed as per EN 285/HTM Guideline. Which includes Empty Chamber , Heat Distribution & Penetration study with and without Load. The Reporting formats consist of F0,Fd,Fh, Mini. & Max. temperature at all locations, Graphical Representation of temperature Vs Time, Hot & Cold spot , and Lag Time.

Test Includes,

  • Dry Heat Sterilizer(DHS)
  • De-Progenation Tunnel
  • Lyophalizer
  • SIP/CIP and Mfg.
  • ETO Sterilizer
  • Tray Dryer

Bung Processor

Double Door Autoclave

tunnel

Vertical Autoclave

HVAC Validation

2i AT Iphotometer

Capture Hood

Particle Counter

TSI Anemometer