Validation

Today’s working environments must adhere to strict regulation for biodecontamination. A single ‘proving cycle’ is not enough to show a functioning system. Whether for airflow check and particle counts or full cycle development, our validation team can provide you with complete documentation and reporting for your regulatory requirements.

Ensuring lasting and efficient system operation requires a solid starting knowledge base. Through practical exercises, in-person training and e-learning options, we equip you with the skills you need to run and maintain your system at optimal levels. Our technical team also supports you as needed after you have finished your training.

Bioquell’s experts install your decontamination system correctly within your production timeline. From standard to more-complex systems, we move you from new boxed unit to fully configured set-up. IQ confirms all the required components are present, correct and in good condition; this includes key documents and calibration certificates.

Once you’ve configured your system parameters, verifying your decontamination system is meeting them is vital. Bioquell’s validation team tests and reviews your system to authenticate proper functionality and operation within specification.

We develop rapid and efficient Hydrogen Peroxide Vapor cycles that fit your process requirements. This creates optimal settings by adjusting the parameters of a series of live cycles in a desired target area through various proven techniques to achieve a 6-log kill. The validation engineer’s expertise and Bioquell’s established methodologies help provide you with the best fit for your area.

Your system is set up and operating as it should. Now we challenge the system by confirming that the developed cycle parameters remain consistent under a defined changed set of circumstances. Biological and chemical indicators are used to help ascertain the results.

In this comprehensive option, we confirm that the developed Hydrogen Peroxide Vapor cycle parameters showcasing a full kill in a designated space are capable of being reproduced. As always, extensive documentation will be provided as support.

We offer Requalification Cycles as often as your protocols or regulatory needs require. We take the steps needed to confirm that previously established cycle parameters set from a GCD are still effective and valid.