Guidance on PDA 468 Validation Processes:
Moist-heat sterilization is a widely used method for ensuring the safety and sterility of medical devices and pharmaceutical products. To ensure that these processes are effective, it is essential to validate them through a rigorous testing program. One important standard for validating moist-heat sterilization processes is PDA Technical Report No. 68 (PDA TR 68).
PDA 468 Validation provides guidance on the validation of moist-heat sterilization processes using steam. The report outlines the critical parameters that must be considered when developing a validation program, including the type of product being sterilized, the intended use of the product, the sterilization method, and the process conditions.
Establishing Temperature Distribution:
One of the key aspects of PDA TR 68 is the requirement for establishing a temperature distribution within the sterilization chamber. This involves conducting temperature mapping studies to ensure that the sterilization process achieves the desired temperature throughout the entire load. This is critical for ensuring that all microorganisms present within the load are effectively killed.
Monitoring and Control:
The report also emphasizes the importance of developing a robust monitoring and control system for the sterilization process. This includes monitoring critical process parameters such as temperature, pressure, and exposure time, as well as implementing process controls such as alarms and automatic shut-off systems to prevent deviations from the established process parameters.
Comprehensive Validation Protocol:
In addition, PDA TR 68 highlights the importance of developing a comprehensive validation protocol that includes a detailed description of the sterilization process, the testing methods used, and the acceptance criteria for validating the process. The protocol should also outline the qualification and training requirements for personnel involved in the validation process.
Overall, PDA TR 68 provides a comprehensive framework for validating moist-heat sterilization processes using steam. By following the guidance outlined in this report, manufacturers can ensure that their sterilization processes are effective and that their products are safe for use. The importance of this validation process cannot be overstated, as it is crucial for maintaining the integrity and safety of medical devices and pharmaceutical products.
From 23rd to 25th of March, PDA will organize a training course about the Validation of Moist-Heat Sterilization Process.
It will be held in person, at the Fedegari facility in Sellersville, PA. It is a unique occasion to build a strong hands-on understanding of sterilization science and ongoing process control.
It will be inspiring and very interactive, including brainstorming and practical example.
You can bring your own load items to have a practical example of sterilization processes.
If you want to discuss PDA 468 Validation, please feel free to write to us by filling out this contact form