Services
Risk Analysis
Any change to the process, product or sterilizer must be subject to a risk assessment of the potential impact on the effectiveness of the sterilization process. The results of the assessment, including the justification for the decisions taken, must be documented.
Any change to the process, product or sterilizer must be subject to a risk assessment of the potential impact on the effectiveness of the sterilization process. The results of the assessment, including the justification for the decisions taken, must be documented.
The following (non-exhaustive) list provides some examples of changes that require assessment:
| Event | Example | Measures |
|---|---|---|
| Replacing a part: if doing so could result in a change in a process parameter. | Pressure sensor Temperature sensor Vacuum pump | OQ / PQ |
| Replacing a part if doing so could cause an increase in leakage into the sterilization chamber. | Valve Piping | OQ / PQ |
| Change of location | Reconstruction of the AEMP leads to a new location for the sterilizer | IQ / OQ / PQ |
| A change in the homogeneity in the sterilization chamber / change in the loading configuration not covered by the reference load. | Change in loading (quantity, composition) | RQ |
| New or modified software and/or hardware | Software update Changing the controller | OQ / PQ |
| Any change in a process parameter | Programming a new cycle Parameter changes before or during hold time | PQ |
| Any changes to the sterilizer's operating resources (e.g. water), including after maintenance. | Change in steam supply New water treatment plant | IQ / OQ / PQ |
| Any change in packaging and/or packaging method | Other type of fleece Other type of sterile container | RQ |
If replacing a part could result in a change in a process parameter (e.g. pressure sensor, temperature sensor, vacuum pump), both Operational Qualification (OQ) and Performance Qualification (PQ) must be repeated.
If replacing a part could cause an increase in leakage into the sterilization chamber (e.g. valve, piping), both OQ and PQ are required.
A change of location (e.g. reconstruction of the AEMP leads to a new location for the sterilizer) requires a full IQ/OQ/PQ qualification.
A change in the homogeneity in the sterilization chamber or change in the loading configuration not covered by the reference load (e.g. change in loading quantity or composition) requires a Requalification (RQ).
New or modified software and/or hardware (e.g. software update, changing the controller) requires OQ/PQ to be repeated.
Any change in a process parameter (e.g. programming a new cycle, parameter changes in the area before or during the hold time) requires Performance Qualification (PQ).
Any changes to the sterilizer's operating resources (e.g. water), including after maintenance (e.g. change in steam supply, new water treatment plant) requires a full IQ/OQ/PQ.
Any change in packaging and/or packaging method (e.g. other type of fleece, other type of sterile container) requires a Requalification (RQ).
Qualification Abbreviations
Imtech-Steri is happy to assist with the preparation of the risk assessment. Imtech-Steri also performs validation and requalification after the adjustments. Validation →
Need Help With Risk Assessment?
Trust Imtech-Steri AG to optimize the sterilization process with innovation, reliability and know-how at the forefront of the sector.
Get in Touch