Following List of activities will be carried out for Vertical Autoclave validation Process
- All Temperature data will be collected using a Standard & Reputed make Data Logger.
- Data logger would log the data through premium quality temperature sensors.
- Calibration of each Temperature sensor would be traceable to National Standards.
- The validation process (Thermal Mapping process) would be carried out with the help of 4/8-temperature sensors and 4/8-channel data logger.
- The sensors will be kept at various corners and at the center of the chamber to acquire results from the most favorable area and the least favorable chamber areas, making the average resulting data uniform throughout the chamber.
- All the data logging of the resulted temperature parameters will be done online.
- After completion of VALIDATION PROCESS, EIE will provide a comprehensive validation report package that includes a summary of all test results including deviations, the executed protocol, test data, test equipment calibration data with Nationally traceable calibration certificates. The validation report package is carefully prepared, reviewed and submitted for client approval.
- Mapping will be carried out for one set of temperature parameters for 24 hours. For an example, 27 °C is called one set of Validation parameter. For more than one set of parameter such as 27 °C , 40 °C extra cost will be applicable.
Performance Qualification
- For performance Qualification we will perform empty load and full load thermal mapping, using the same configuration for the sensors as in the empty chamber study. The minimum study time for this requirement is 24 hours.
Note:
- Transportation, loading & boarding charges should be reimbursed as per the mutual agreement.