Wijnegem, Belgium, September 14th 2016: Novosanis has built a clean environment at their headquarters in Wijnegem. The installment is divided in two spaces: one clean area grade D for prototyping and manufacturing of VAX-ID™ and Colli-Pee™, and one closed-off laboratory to conduct experiments.
The clean area is installed to reduce the concentration of airborne particles to a minimum by tightly controlling air flow rates, pressurization, temperature and humidity. Contaminants, generated by staff, the production process, the surroundings and tools, are scaled down using overpressure, HEPA filters, and training of staff.
Engineering partner Voxdale defined the area’s lay-out and architecture, and optimized the internal fluid dynamics of the room.
"The expansion of our clean environment will allow us to upscale our medical device assembly. We are committed to offer our customers high quality products, by investing in the latest technologies." says Timothi Van Mulder, Quality Manager.
For more information, please contact:
Koen Beyers, Chief Technology officer, Novosanis
Timothi Van Mulder, Quality Manager Novosanis
+32 3 485 50 16
Novosanis is an innovative developer and producer of medical devices adding value to the accuracy of diagnostics tests, drug delivery and overall patient’s comfort.
We are a Belgian, award-winning, ISO13485 certified medical device company active in the field of infectious diseases and oncology in the areas of prevention, detection and treatment.
Novosanis prospers in user-friendly and clever medical devices meeting all regulatory and quality requirements, solutions that can improve the accuracy and standardization of the diagnostic test and drug delivery while making the handling easier, more consistent and more comfortable for the person.
We have two device platforms in portfolio: VAX-ID™ is a patented and proven platform of injection devices suited for accurate drug delivery of e.g. therapeutic, prophylactic and allergy vaccines in the dermal layer of the skin and Colli-Pee™ is a patented and CE-marked sampling device suited for standardized and volumetric collection of first-void urine (first 20ml of the urine flow) allowing improved detection of infectious diseases and early stage cancer. Colli-Pee™ is in a commercial stage.