Thermal validation

We are submitting Reports and Protocols which are complies maximum regulatory bodies like USFDA, TGA, MHRA, WHO, 21CFR etc..

Validation Protocol Includes Procedure/Pass Criteria/Lethality & Fo and Fh Calculations, Color Graphical representation/ Min.& Max for each point Temperature, Hot & Cold Spot, Conclusion and result.

Our reports includes Graphical Representation, Lethality and F value calculation and Summary Reports.

We also Provide Temperature Mapping Report with Mean Kinetic Temperature (MKT).

4a. Equipment Validation

Why Validation is required for Equipments?

Sterilization (or sterilisation) is a term referring to any process that eliminates (removes) or kills (deactivates) all forms of life and other biological agents (such as viruses which some do not consider to be alive but are biological pathogens nonetheless), excluding prions which cannot be killed, including transmissible agents (such as fungi, bacteria, viruses, prions, spore forms, unicellular eukaryotic organisms such as Plasmodium, etc.) present in a specified region, such as a surface, a volume of fluid, medication, or in a compound such as biological culture media. Sterilization can be achieved with one or more of the following: heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization in that sterilization kills, deactivates, or eliminates all forms of life and other biological agents.

For Sterilization Below Temperature is required for Kill/Remove Micro organism.

1) 121.1oC for 15 minutes

2) 131.0oC for 3 minutes

Mapping is required to check whether above temperatures is achieved through out cycle or specific time periods.

Following various equipments and Ares are validated by us:

  • Autoclave/Terminal Sterilizer (Sterilization process)
  • Sterilizing Tunnels (Depyrogenation Process)
  • Steam In Place (Manufacturing & Holding vessel and fermantors sterilization process)
  • Dry Heat Sterilizer (Dry heat sterilization process)
  • Lyphilizer (Chamber sterilization and Freeze drying process temperature distribution)
  • Bung Washer and Sterilizer

4b. Temperature and % RH Mapping:

Why Temperature and % RH Mapping Requirment in warehouses (Storage Areas) and Classified Clean-rooms ?

All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before the installation is commissioned and handed over by the installer. Until this has been done, it is not safe to store TTSPPs in such areas. The temperature mapping procedures should:

  • Demonstrate the air temperature profile throughout the storage area, when empty and in a normal loaded condition;
  • Define zones which should not be used for storage of Time and Temperature – Sensitive Pharmaceutical Products (TTSPPs) (for example areas in close proximity to cooling coils, cold air streams or heat sources); and
  • Demonstrate the time taken for temperatures to exceed the designated limits in the event of power failure. Subsequent mapping exercises must also be carried out on a periodic basis – for example, every three years – in order to demonstrate continuing compliance. In addition mapping should be carried out whenever significant modifications are made to the store. Examples include changes in the pattern of use that may increase loading or affect air circulation, or changes to the refrigeration equipment, such as an alteration to the set point. All mapping exercises should be fully documented in order to demonstrate compliance to management, clients and the regulatory authorities.

Following various equipments and Ares are validated by us:

Temperature / Humidity Mapping of Equipment Temperature / Humidity Mapping of Area
  • Stability Chamber
  • BOD Incubator
  • Vacuum Oven
  • Drying Ovens
  • Cooling Chamber
  • Walk in Cold Room
  • Deep Freezers
  • Cryogenic Freezers
  • Glassware ovens
  • Raw Material Storage Area
  • Packing Material Storage Area
  • Capsule Storage Area
  • Retain Storage Room
  • In-process Material Storage Area
  • Production Processing Area

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