What makes a retort FDA compliant?
A retort qualifies under US FDA norms when it meets seven basic requirements, each of them a piece of control or recording equipment. Meeting them makes the retort ready for validation. The validation is what qualifies the process and the products.
The basic requirements
- Automatic control of the process
- Every critical parameter, including temperature, pressure, flow rate and water level, is controlled as programmed for each product. The retort must run the set parameters fully automatically. No manual controls are allowed.
- Recorder
- A recorder logs temperature, pressure, flow rate and the other crucial parameters of every process, and the records are kept for evaluation. The recorder itself must comply with FDA regulations.
- Retort control sensor
- A reliable, high-quality control sensor with good accuracy. This is the sensor the controller acts on, so every process the retort runs is only as good as this reading.
- Reference sensor and data output
- A high-quality, internationally approved temperature indicating device (TID) verifies the control sensor, confirming there is no deviation between the two readings during processing. It needs a data output so the readings can be printed. A good-quality mercury-in-glass thermometer (MIG) can serve as the TID, but then a chart recorder is needed for the printout.
- PID controller
- Process parameters must repeat the set program run after run. A PID controller is advised to confirm that repeatability, and it controls the temperature and pressure ramps.
- Flow meter and water level
- A proper flow meter with its controller, plus a water level indicator for water spray retorts.
- Handling process deviations
- The retort should have facility to monitor the processing properly and should be able to apply additional protection program in case of unforeseen deviation of the performance of the supply sources.
How the retort and products get US FDA approval
The Retort Processing will be qualified for US FDA only after doing the proper validation of the retort and products based on the utilities ( steam, air, water supply sources), loading pattern, loading capacity, container orientation, container protection process ( proper over pressure control setting ), product characteristics and performance etc. The validation expert ( Process Source Authority) should study and analyze the retort conditions and product characteristics and performance and establish the proper processing parameters for each type of products to meet FDA norms.. The Heat Penetration Study (product validation) should be performed using proper reliable high accurate sensors and fittings to simulate actual production conditions. The sensor geometry should confirm that it measures the temperature from the cold spot of the containers and also the temperature of the hardest product piece. This ensure to set the control program for 100% safety to the product in the containers.
The retort should have proper repeatability of the process and confirms that the products placed at every part of the retort ( even at Cold Spots) achieve proper sterilization effect, to confirm safety to the full load . The established process control program should optimize the processing and take care of adverse / unforeseen processing conditions and ensure 100% safety and highest possible quality to the finished products. The retort should have proper additional program to protect the batch , in case of unforeseen deviation of the performance from the supply source.
The established control program should optimise the process, take care of adverse or unforeseen conditions, and deliver 100% safety with the highest possible quality in the finished product. It should also carry an additional program that protects the batch if a supply source deviates from its expected performance.
For how the heat penetration study is done, see conducting the perfect retort validation. For testing the retort itself, see retort qualification testing.
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