Azzur Labs has extensive experience in developing and executing cleaning validations and verifications. Our experts can support your team through the duration of your validation project. We have extensive experience in developing Master Validation Plans and the Cleaning Validation Protocol. Our team will execute the protocol, complete the analysis, as well as train your employees and offer support and recommendations for cleaning agents and cleaning procedures. Regulation compliance is a critical component to cleaning validation, and Azzur Labs will work with you to ensure your program is compliant across regulations.
This study is needed to prove that there is no carryover of residue onto the next product. Carryover includes but is not limited to: previously manufactured product, byproducts, products from degradation, lubricants, cleaning agents and solvents.
The study is completed in both the facility, as well as our laboratory. All studies begin in our laboratory to ensure that the method of detection is appropriate. Some of these studies consist of obtaining evidence regarding linearity, accuracy, precision, stability, intermediate precision, percent recovery, limit of detection and limit of quantization.
Once a suitable detection method has been determined, the cleaning validation plan is executed at the facility.
If the study shows that removal techniques were not effective to reduce all compounds of interest to an acceptable level, the user must modify the procedure and repeat the study. Modification may include contact time, changing the scrub time, changing the rinse water temperature or changing the agents, etc.
After the method has been validated, the user will develop a schedule to sample the equipment on a routine basis to verify that the agents and methods are still acceptable.
There are two methods of accomplishing a residue study: Specific and non-specific.
This study is set up to recover only the compound of interest, and will not identify any compounds other than the compound of interest. This study should be used if you have a potent compound, the compound cannot be detected by a non-specific method, or you are having difficulty in removing a specific compound.
Non-specific studies will indicate if the surface is within limits of all compounds of interest without the need to run individual samples. However, if the sample tested is above the acceptable level, the user cannot determine which compound or compounds were present.
Have questions about cleaning validation? See our answers to the most frequently asked questions.