GAMP Group offers Retort Qualification & Retort Validation includes Temperature Distribution, Heat Distribution and Heat Penetration Studies.
Temperature Distribution Tests are designed to ensure that the sterilizer is at a uniform temperature, at the start of the process timing and throughout the cycle in all areas of the sterilizer. TD studies must be designed to locate the slowest heating area in the sterilizer and to determine the parameters required to bring that area of the retort to a minimum uniform temperature throughout the process cycle.
Heat Penetration Study: The purpose of the heat penetration study is to determine the heating and cooling behavior of a product / package combination in a specific retort system for the establishment of safe thermal process and evaluating process deviations. The study must be designed to adequately examine all critical factors associated with the product , package and process which affect heating rates.
Heat Distribution Study: is mandatory for Steam/ Air retorts. HD study is performed to determine a correlation between the retort temperature and the lethality obtained by the product. HD study helps to determine the heating variations due to air pockets. If air pockets are present, the lethality varies amongst the containers significantly, even if the retort temperature remined constant.
For each sensor placed in the cold spot of the container, a corresponding sensor would need to place in the retort immediately outside of the container , in order to determine the correlation between the retort temperature and the lethality obtained by the product. The HD study helps to identify the cold spots within the retort that would not be detected with a temperature distribution study.
It is to be noted that an error of 1 deg C during the sterilization process ( at 121 deg C) changes the Fo value by 26%. So it is important to use reliable and high accurate sensors with proper fittings for the process technology development and regular monitoring applications. It is also important to mount the measuring needles exactly at the cold spots of the containers for heat penetration studies and regular process monitoring applications.
H.P Studies are designed to determine the precise processing technology of a particular product in a particular container. The worst case scenario needs to be simulated during the studies and confirm that the products would be safe during the processing even in the adverse processing conditions
The retort is a closed pressure vessel used for the thermal processing of food products. It can be handled / programmed with time / temperature / pressure profiles as per the user’s requirements. Before using the retort for commercial production, it need to be set up as per user specifications and requirement and make sure that it meet international quality standards and safety norms.
There is no pre-defined fixed processing technology for retort processing of any specific products. But there are proper guidelines for retort processing of various types of products packed in different types of containers. The processor need to follow the guidelines strictly and fine tune the technology based on the type of recipe / ingredients of the product, type of packaging, type of retort and available accessories, type of filling machines, available utilities etc. The temperature / pressure ramping at come up time phase and cooling phase are very critical, when processing in flexible containers like pouches, plastic trays, cups etc.
The food sterilization is normally carried out by obtaining the Fo / Po values achieved by the products packed in hermitically sealed containers ( pouches, cans, bottles, trays, cups etc) during processing. The quality of the finished products depends on how fast the products achieve the target sterilization. The attainment of safety and quality are equally important. During installation time, the user should make sure that the retort settings are optimized properly to archive most optimized output within the safety limits.
A systematic or experimental error of 1 deg C in a temperature measurement system at the sterilization reference temperature of 121.1 deg C, would lead to a corresponding error of 26% in the calculated Fo sterility value of the product. Hence it is very important for the processor to make sure that the retort is installed properly and do the performance qualification testing properly before start using the unit for commercial production. As the retort being a pressure vessel, operated at around 2 to 3 bar pressure inside the chamber, it is very important to make sure that all the safety precautions are taken care properly and the user receives proper training on proper operation, documentation and handling unforeseen emergency situation occurred during production.
For those processors, who are intending to export to foreign countries, make sure that the received retort have proper accessories and facilities to meet the international quality norms, especially meet FDA norms and regulations.
The qualification process for retort is critical in ensuring that these machines operate effectively and meet regulatory standards. This process is divided into three key stages :
Installation Qualification (IQ)
Ensuring Correct Installation - This phase verifies that the retort is installed correctly and that all required components, utilities and equipment are present and meet design specifications.
Operational Qualification (OQ)
Validating Operational Integrity - In this phase, the retort’s operational parameters are tested to ensure it functions consistently within the predefined limits.
Performance Qualification (PQ)
Confirming Sterilization Effectiveness - OQ evaluates the retort‘s performance in actual operational conditions, focusing on load-specific requirements.
The IQ, OQ and PQ need to be performed to confirm that the retort consistently meets the required Sterility Assurance Levels (SAL).
Conducting a comprehensive risk assessment to identify potential operational risks and mitigation strategies is essential.
Documentation Review and Approval
Ensure that all essential documentation is thoroughly reviewed and approved. This includes the Validation Master Plan (VMP), User Requirement Specifications (URS) and Design Qualification (DQ), which outline intended uses, operational parameters, validation strategies, resource allocation, timelines and quality requirements.
Standard Operating Procedures (SOPs)
Develop and validate SOPs covering all operational procedures, safety protocols, maintenance routines and emergency procedures to provide a consistent framework for retort use.
Calibration and Maintenance
Verify that sensors, gauges and other critical instruments are calibrated according to industry standards. Establish regular maintenance schedules to upload operational integrity and compliance
Developing Cycles and Load Patterns
Cycle development is crucial for retort processing applications. The goal is to ensure consistent sterilization of each load. Develop the cycles thoroughly before Performance Qualification (PQ) validation, and test various load patterns for uniform temperature and pressure distribution.
Training of Personal
Ensure operators and maintenance staff are adequately trained on the specific model of the retort, including operational procedures and safety measures. Document and regularly update training materials.
Risk Assessment
Conduct a comprehensive risk assessment to identify potential operational risks and mitigation strategies. Addressing potential failures on non-conformities during qualification is crucial.
Installation Qualification (IQ)
Ensuring Correct Installation: This phase verifies that the retort is installed correctly and that all required components, utilities and equipment are present and meet design specifications.
Confirmation of Equipment Installation
Verify the setup and installation against engineering drawing. Confirm that the required accessories and controllers are provided to meet international quality standards and requirement of FDA.
Utility Connections and Calibration Status
Confirm utility connections and check that all sensors and operational components are calibrated, using either in-house resources or a reliable calibration provider.
Review of Operational Manuals and Safety Procedures
Ensure all operational guidelines and safety protocols are up to date and clearly documented.
Operational Qualification (OQ) : Validating Operational Integrity In this phase, the retort’s operational parameters are tested to ensure it functions consistently within predefined limits.
Testing Controls: Examine the retort controls for temperature, pressure and ramping and cycle times to ensure they operate within specified parameters. High accurate pressure sensors and temperature sensors will be used for this testing.
Validation of Alarms and Safety Features: Ensuring all alarms, safety features and fail-safes are operational and effective.
Evaluation of Cycle Reproducibility: Validate cycle consistency and reproducibility using representative load patterns.
This phase involves extensive testing for heat distribution and penetration to ensure uniform and effective sterilization capabilities. Alarms and control systems are rigorously tested to verify their functionality in detecting and managing operational anomalies.
PQ evaluates the retort's performance in actual operational conditions, focusing on load-specific requirements.
Full-Load Cycles: Running full-load cycles to assess sterilization efficacy and ensure consistent performance.
Monitoring Temperature and Pressure Distribution: Analyze temperature and pressure distribution throughout each cycle to ensure uniformity inside the process chamber.
Verify Cycle Reproducibility and Consistency: Ensure that the retort performs consistency across different load types and conditions.
The retort’s IQ, OQ and PQ tests can be performed using Ellab Thermal Validation System with temperature and pressure sensors. It not only streamline the entire qualification process, but also ensure that the operations meet stringent regulatory standards with greater ease and efficiency.
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+91 9879594538 |
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