NOVUS has invested in building and maintaining our own production sites in Hong Kong and Shenzhen. Our production sites meet cleanroom standard as high as ISO 14644 ISO 5 or Class 100 with most of the process room reaching ISO 14644 ISO 6 or Class 1,000. Throughout the years, NOVUS has gained valuable experiences in running projects involving medical devices, cosmetics and biotechnology. The infrastructures have empowered us to speedup standardized production processes.
Both our Hong Kong and China manufacturing site has met the ISO requirements.
ISO 14644 “Cleanrooms and Associated Controlled Environments”
ISO 13485 “Medical devices — Quality management systems — Requirements for regulatory purposes”
#picture: a HEPA airshower in NOVUS's cleanroom
NOVUS's scientists and engineers are experienced in synthesis of biomaterials. A successful synthesis of a new material always starts in the laboratory. However, it is another challenge in turning experimental protocols into production standard operating procedure (SOP).
Walking from the laboratory to producing a successful product, NOVUS is equipped with the necessary research and production equipment under the same umbrella. This helps our scientists and engineers to accelerate the transition from R&D innovations into successful products on the market.
#picture: an industrial scale pharmaceutical grade freeze dryer in NOVUS's cleanroom
NOVUS has advanced production lines in Hong Kong and Shenzhen. In each of the site, high quality medical product production and packaging can be done in a one-stop-shop. Quality assurance is met according to industry standards. As simple as a Tyvek cover, peel test is performed in-house as a QC process to make sure that the product can survive transportation, shipping, and storage.
#picture: a medical device blistering machine in NOVUS's cleanroo
Sterilization is a key process of medical device manufacturing. NOVUS is equipped with industry standard sterilization system - ethylene oxide (EtO) in order to safeguard the safety of our products. In-house sterilization is part of our productio SOP to lower the risk of contamination.
#picture: an ethylene oxide (EtO) sterilization equipment in NOVUS's sterilization room