Validation

Thermal /Equipment Validation

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.

We provide high quality Qualification Services for Equipment & Facilities. Our experience in Temperature / Humidity Mapping allows us to offer our customers a wide range of services. We can help our customers to established methods & Protocol based on current GMP Trends and best practices followed in Industry.

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.

Our range of Services in Thermal Validations,

  •  Autoclave, DHS, Depyrogenation Tunnels, Ovens
  • Warehouse , RM Stores, Labs, Production Area
  •  Stability Chambers, Refrigerators, Freezers, Incubators, Cold Chambers
  •  Vessels, Tanks, Filters, Fermentors
  •  Water Baths, Muffle Furnace, Vacuum & LOD Oven, Other QC Equipments.