Critical aspects of temperature validation for sterilization equipment

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Sterilization Process

Sterilization is an important process used in the healthcare industry, pharmaceutical companies, and related industries to ensure that medical products/devices and medicines,…. (especially for infusions and injections in the pharmaceutical industry) are free of harmful microorganisms.
To assess and reduce risks, improve product quality to ensure safety for human health and life, helping to maintain and improve the reputation of the manufacturer… Temperature validation for sterilization equipment (e.g. autoclaves, drying cellars, freeze-drying,…) is essential to prove that the temperature values throughout the sterilization process are maintained and controlled within acceptable limits, especially for companies and pharmaceutical factories that have been aiming to meet rigorous standards such as EU-GMP and FDA.

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Temperature validation for sterilization equipment

Temperature Validation

Temperature validation is the process of using temperature sensors arranged throughout the space inside the sterilization equipment to evaluate the accuracy, stability, and uniformity of temperature and time while sterilizing. With only a small deviation value outside the acceptable temperature limit, the risk to products, drugs, and medical devices is extremely large, potentially causing users and manufacturers detriment. Therefore, the temperature value during the sterilization process must be evaluated, controlled, and maintained following the requirements of the sterilization method being used.

Special attention when validating temperature

1. Sensor calibration and verification

Based on the guidelines on Quality Risk Management from the FDA/EMA (such as ICH Q9, etc.), it is essential and must be considered for the calibration and verification of the sensor before and after each temperature validation process. The fact that some pharmaceutical factories rely solely on sensor calibration certificates from the calibration facility and then use those sensors to validate sterilization equipment without the need to re-calibrate and verify the sensors is risky. Because temperature sensors (such as thermocouples) are highly accurate, when operating under the extreme temperature conditions of the sterilization process, they are all susceptible to errors, which can lead to deviations beyond the acceptable limits. Therefore, it is necessary to perform sensor calibration and verification for each sterilizer validation to minimize the risk to the lowest level.

Temperature validation procedure

When performing calibration and verification of temperature sensors, it is necessary to have a standard heat source generator (such as a dry heat well or oil heat tank) that has high stability, uniformity, and accuracy. Besides, a standard temperature sensor (with the accuracy is at least 3-4 times better than the sensors to be calibrated) is required for reference and comparison.

Dry well and standard temperature sensor

2. Traceability, Data Security, and Data Integrity

In accordance with Data Integrity standards such as FDA 21 CFR Part 11 and EU-GMP Annex 11, all paper and electronic data/records, and electronic signatures must be complete, consistent, and accurate throughout the product lifecycle – from initial data generation to processing, reporting, storing, retrieving and using when inspectors come to inspect and assess.

The Audit Trail for all actions taken during the validation process, such as what action is performed (What), who performs the action (Who), why the action is performed (Why) and when the action is performed (When), must be recorded with electronic signatures and cannot be modified to ensure transparent, clear, and accurate data. This makes it easier for pharmaceutical companies and factories to pass the tests from inspections when auditing.

3. Monitor the pressure value when validating the autoclave temperature (Autoclave)

According to HTM2010, besides monitoring and controlling the temperature value during the sterilization process, the pressure value is also a parameter that needs to be monitored and recorded along with the temperature value

4. Statistics analysis, draw trend charts, and make validation reports

The equipment/system used for temperature validation must be able to analyze statistical parameters (such as maximum, minimum, average, standard deviation, etc.) and Lethality values during sterilization. In addition, a function to plot a trend chart (temperature value over time) is required for easy tracking and evaluation.

All reports on the validation process, traceability reports, calibration reports and sensor verification… must be created, exported, stored and backed up by the system in the most optimal way.

Temperature Validation Solution from KAYE

KAYE is one of the industry leaders in temperature validation with products that are popular all over the world. With more than 65 years of experience in the pharmaceutical industry, KAYE has brought an advanced temperature validation solution – KAYE Validator AVS – to meet the requirements when performing temperature validation with outstanding features such as:

  • Address sensor calibration and verification requirements for each validation. Easy integration with standard heat wells/heat tanks and standard sensors to perform calibration and verification automatically.
  • Able to integrate, read, and record data with many different types of sensors (Thermocouple, RTD, Pressure Transducer, 4-20mA or 0-10V signals, etc.).
  • The system has an optimal measurement uncertainty (Uncertainty); Along with the high measurement range and accuracy of the sensors are suitable for a wide variety of applications.
  • The system meets standards such as FDA CFR 21 Part 11, EN285, etc., with an Audit Trail function to help ensure Data Integrity.
  • In addition, the system also has the function of calculating statistics, drawing trend charts, and making validation reports easily.

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