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Increasing the reliability of recipe cleaning and instilling confidence in the effectiveness of our cleaning processes is an important lever in improving the effectiveness of validation practices.
Acquiring or modifying a clean process does not necessarily guarantee good results from the first cycle. The industrialist should allow for the risk of cycles with poor performance on soils or residues. The cleaning process design should be defined in terms of contact products, equipment, upstream processes and cleaning steps, and should be done as early as possible in the cleaning process design, working in partnership with the supplier. This step will enable an initial savings in clean process reliability testing.
When defining the design of the cleaning process, tolerances should be defined that are representative of the selected technologies and strong enough to avoid approaching the performance limits of the cleaning process.
It is therefore up to the industrialist to perform reliability checks on cleaning recipes before engaging in the cleaning validation process.
These reliability tests can be conducted in a variety of ways, with or without a product, and before and/or after the equipment is qualified.
By developing cleaning cycles as early as possible, the parameters that contribute to the efficiency of the cleaning process can be clearly established. Critical parameters and process steering parameters are thus defined with associated tolerance values. A risk rating for each stage of the cleaning cycle allows these two types of parameters to be defined. This will result in steering tests on the limit values of each parameter affecting cleaning efficiency.
Any inconsistencies or inconsistencies observed in cleanliness parameters during functional equipment qualification tests must be analyzed and corrected following a quality process. Modifications made to cleaning parameters may affect cleaning cycles created prior to qualification. If this is the case, changes in the cleaning parameters must give rise to more cleaning cycle reliability testing with additional tests to confirm its effectiveness.
Another factor that can be done simultaneously in addition to the cycle is the location of the equipment in the trolley or basket in the washing machine. By testing different loads depending on the type of equipment, a full or partial load may or may not be the worst case.
For reliability testing with products, a theoretical cleanliness matrix must be prepared to determine the worst-case products for testing or use an artificial soil close to the product characteristics. After the reliability test step, it is not impossible to change these theoretical choices because other products that were not selected in theory may appear after this test, depending on all the steps of the cleaning process.
The operating conditions for testing this product must take into account any adverse factors for cleaning, such as heat treatment or any other additional treatment.
Maximum fouling retention times should also be applied as a negative factor. The number of tests performed depends on knowledge of the product, equipment and cleaning process.
“Analytical” tests are also necessary during this cycle optimization phase. A more rapid analysis than that required in validation exercises may be used. They will provide quick results on cycle consistency, for example the absence of protein via rapid-detection swabs, process or remote analysis of TOC (Total Organic Carbon), or responsive feedback on the pH or conductivity of the final wash water.
Acceptance criteria values for analytical measurements can be a factor considered unfavorable for cleaning cycle performance. Cleaning cycles must be developed to achieve those acceptance criteria. This will therefore have a potential impact on fluid injection time, fluid volume, fluid temperature, equipment position and other TACT (Time-Action-Chemical-Temperature) criteria. Reproducibility can also be assessed during this reliability testing phase once the cleaning process is defined and to check its robustness.
This step is an integral part of the cleaning validation process as it prepares the cleaning process not only for its validation but also for its daily use and thus maintaining its validity over time.
Modification and optimization of cleaning recipes and critical or steering parameters must be backed up by documents before cleaning can be validated; This stage can be considered as a preliminary or prerequisite to start validation.
