The verification phase of the effectiveness of glove box decontamination produced by CSV Containment is meticulously carried out, thanks to the experience gained by our teams in cleaning validation and monitoring the containment level according to SMEPAC standards.
It involves a qualitative and quantitative verification of glove box decontamination effectiveness. The two verification procedures, SMEPAC monitoring and cleaning validation, provide us with useful data to assess the proper functioning of decontamination and identify any critical issues, especially during the washing phase.
This approach allows us to objectively and repeatably determine if there are any residual substances inside a glove box after an adequate washing cycle. Although the testing operations are conducted using surrogate active ingredients, the derived data is essential for understanding how to protect operators and products during subsequent production activities following the decontamination of the isolators, thus avoiding compromising the quality of each batch produced.
What is the purpose of cleaning validation?
Cleaning validation aims to ascertain and document the elimination of contamination sources. It considers machine components, washing procedures, products processed in the glove box, as well as detergents and solvents used as cleaning agents. Typically, this activity is carried out at the end customer’s facility, where we collaborate to devise the most effective strategy for the system. Undoubtedly, the tests previously conducted at CSV Containment are crucial to proceed correctly. The operations performed in the factory (sometimes on-site) serve to determine the effectiveness of decontamination and washing, as well as identifying the “WORST” sampling points where potential contaminant residues may be found. Usually, the focus is on entry ports, surfaces that are more challenging to clean or inaccessible to washing/decontamination agents, valves, or drain points where product or processed material residues may be detected.
This procedure helps determine the most difficult-to-clean areas, and the use of tracer liquids is a very useful methodology to identify them. Riboflavin, essentially vitamin B diluted in water, is commonly used. It is sprayed on the isolator walls and the most challenging places to reach (e.g., between glove fingers or behind filters). Why? Because riboflavin exposed to UV light becomes fluorescent. Once the solution is sprayed, the UV lamp is used to verify that all significant surfaces for washing have been covered and, more importantly, to trace the interesting areas that are more difficult to decontaminate/wash. Subsequently, a new washing is performed, and the UV lamp is used again to check for traces indicating incomplete washing. During qualification, this type of test is also documented with a video. Therefore, it is a crucial test to help determine the ideal points for cleaning validation.
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: firstname.lastname@example.org