Qualifications and personalised projects
IQ, OQ and Qualifications
You have just received your Phileas® devices and are eager to start using them? Let Devea help you to perform Installation Qualifications (IQ) & Operational Qualifications (OQ), cycle developments and Performance Qualifications (PQ), according to GMP Annex 15. They will bring their expertise and professional support to get you started with the best protocols matching your requirements!
IQ & OQ: documents are reviewed and approved ahead of the qualifications. On the qualifications day, all parties are present to perform the tests and sign to validate each test compliance. IQ compliance leads to OQ tests. Once operational compliance is validated, performance tests can start: testing protocols with H2O2 in the room or equipment, with chemical and biological indicators to validate the efficacy. Whether you want to optimise your protocol with cycle development, or want to go straight to performance qualifications, Devea will help from protocols, test to final report signature.
IQ, OQ, PQ, the Devea teams will give you the benefit of their DSVA experience in various sectors. An expert view, so that you can ensure effective disinfection according to your specifications.
The Devea teams are also available for any particular project or support. Do not hesitate to contact them to benefit from their cross-sectoral and international experience!
Paule Nowicki, Project Quality Coordinator, Fareva Mirabel, 2025
We developed the Airborne Surface Disinfection cycles with Devea and Phileas® Control² equipment. As we had no experience with biodecontamination, this stage enabled us to test different cycles / protocols to optimise the process and test the entire process in real conditions (not just the diffusion of H2O2and its effectiveness).
Brian McBride, Quality Assurance Pharmacist at Altnagelvin Hospital in Ireland
Devea collaborated with Brian McBride to identify the most suitable protocol for disinfecting isolators in the hospital pharmacy, ensuring safe and reliable 6-log₁₀ disinfection. Thanks to Phileas® centrifugal technology, there was no need to retrofit or replace costly and complex isolators. In this article, Brian McBride explains how he validated the disinfection method: performance qualification through three consecutive cycles using biological indicators (Geobacillus stearothermophilus). Today, he uses several Phileas® Genius devices for the different isolators within the hospital.
Brian McBride, Quality Assurance Pharmacist at Altnagelvin Hospital in Ireland, published his disinfection validation work in the peer-reviewed journal EJPPS in January 2023. He also presented his findings at the French congress ContaminExpo in Paris in March 2023.
Initial or periodic support, training, qualification, validation, requalification, auditing, etc.
Whatever your initial needs, the Devea Biodecontamination Services team conducts an in-depth analysis of your technical and environmental requirements, working directly with you to develop customized solutions that guarantee full compliance with your specifications and regulations.
The documentation accompanying these projects is clear, comprehensive, and compliant.
The diversity of situations encountered with our equipment allows our team to support you and recommend protocols, processes, and specific points that will make all the difference!
