First of its kind at VDU
ICMI is a multidisciplinary team that conducts research on the development and validation of radioactive and fluorescently tagged proteins (mainly nanobodies) that are subsequently used for imaging and therapy. The core business of VDU is producing nanobodies at GMP level for outsourcing in academic clinical studies.
The Steelco autoclave is the first apparatus of its kind within the newly constructed clean room, however similar equipment has been used at the VUB for many years in the field of animalaria projects, where high-level animal experiments are conducted.
Experience and agility
“We already knew about eyetec from previous professional exchanges”, explains Celine Coelis, Operational Manager and QA Assistant of the research group Medical IMAging (MIMA) at VDU. VDU decided to work with eyetec for the installation and follow-up of the autoclave for their new laboratory because of their outstanding reputation. “The fact that they are a Belgian company definitely influenced the decision processes, as this helps with swift follow-up and short reaction time” Celine explains.
eyetec has a proven track-record and vast experience in different fields of QA/QP. eyetec is also very knowledgeable in validation and IOQ execution. Celine agrees that eyetec’s diligent, transparent, and thorough way of working has saved VDU a lot of time. “Other suppliers often just send their IOQ by mail, which makes the execution long and laborious. The fact that eyetec is very responsive, transparent about testing and diligent in their documentation and administration really sets them apart from previous suppliers we’ve worked with”.
eyetec also took care of the validation process, which is usually quite tedious. It requires temperature mapping because it needs to stay constant throughout the different locations. Furthermore, a calibration of nine points is required. eyetec is able to conduct these types of processes independently, resulting in lower operating time for partners. “Because eyetec took charge of the validation process, we didn't have to buy or provide any calibrated equipment to perform mapping”, says Celine.
Testing, maintenance, and other projects
The VDU-autoclave will be fully operational by Q4 of this year. It’s important to test the equipment first and learn how to work with it. Currently the eyetec experts are teaching the operators how to operate the different machine components. The production will start at a later stage.
“Given this positively reliable experience, and the added convenience, we will also work with eyetec for the machine maintenance. We know that if any issues arise, we will be able to count on them to come up with a swift solution. It was the first time working with eyetec, but it won’t be the last. Because the entire process ran so smoothly, we’re already checking if they can help us install freezers and fridges too”, Celine concludes.
Support from A to Z
eyetec always provides full support from A to Z at the customer’s facility, ranging from delivery, installation, set-up and start-up, operational qualification, calibration, performance qualification and training.
If you have questions and are interested in working together, feel free to contact us for more information.