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Equipment Validation

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Place of Origin:
Maharashtra, India

Specifications

TISPL provide high quality Qualification Services for Equipment Thermal Facilities.

Temperature / Humidity Mapping are Very Critical Step in the Validation of any Pharmaceutical Process. To ensure the Safety and Efficacy of Life Science Products. , all Storage and Manufacturing Facilities (From Raw Material to Finished Goods) must be Temperature / Humidity Mapped to show that Storage and Transportation conditions are good for your Products & meeting all Regulatory Requirements.

 

Our range of Services in Thermal Validations.

 

Autoclave, DHS, DehydrogenationTunnels, Ovens

• Warehouse, RM Stores, Labs, Production Area 

• Stability Chambers, Refrigerators, Freezers, Incubators, Cold Chambers

• Vessels, Tanks, Filters, Fomenters

• Water Baths, Muffle Furnace, Vacuum & LOD Oven, Other QC Equipments.

 

We have proper Documentation methods meeting Current Regulatory requirements. Our Documents consist of-

  • Basic Temperature Mapping Data,


  • Calculations like F0, Fh, Min. & Max. Temperature,
  • Standard Deviation,

  • Lag Time Calculation,

  • Identification of Hot & Cold spots,

  • we also provide Graphical Presentation of Temperature V/s Time,

  • Diagram Indicating Sensor location & Validation Summary / Certificate etc.

 

 

 

 

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