Thermal Validation

You spent years developing the product ……………….

You can’t afford to wait that long to VALIDATE

Whether you are subjected to regulatory body audits such as WHO (Schedule M),WHO (Geneva), TGA, USFDA, MHRA, MCC, ENVISA, we can help you with your entire validation requirements for complying with GMP, cGMP, GAMP 5, 21 CFR Part 11 Software Validation and achieve the right level of validation and traceability to National and International Standards.

The Industry refers to VALIDATION as “Establishing documented evidence that a process or system when operated within established parameters can perform effectively and reproducibly to produce a product which meets its pre-determined specifications and quality attributes”. We offer a full range of validation services which includes;

STERILISERS	We perform precise Temperature Mapping Analysis of AUTOCLAVES, DRY HEAT STERILISERS, ETO STERILISERS & TUNNELS which includes empty chamber heat distribution study, load pattern distribution and penetration study. F0, Fd, Fh, min. & max. Temperature, graphical presentation of Temperature V/s Time, Standard Deviation, Lag Time Calculation, Identification of Hot & Cold spots are some of the features of our reports generated through our specially designed software.
QA/QC EQUIPMENTS	Incubators, BOD Incubators, CO2 Incubators, Stability Chambers, Orbital Shakers, Refrigerators, Deep Freezers, Ultra Low Deep Freezers, Water Baths, Hot Air Ovens, Muffle Furnace, Vacuum & LOD Ovens, Cold Chambers, HPLC, GC, Air sampler. The reporting format consists of diagram indicating sensor location, min. & max. Temperature for all locations, graphical presentation of Temperature V/s Time, Hot & Cold spots identification. Reporting MEAN KINETIC TEMPERATURE CALCULATION is our speciality
Ware house Mapping	Autocal offers a complete Temperature & RH mapping service for any warehouse facility in compliance to regulatory guidelines. To comply with current guidelines, mapping of a warehouse must be conducted seasonally. We use small telemetry sensors which have the capabilities of monitoring temperature and RH simultaneously. Due to the size of these sensors, routine operation of the warehouse is not affected during the mapping study.