About 3 to 6% of all newborns require manual ventilation support to start breathing. Monivent has developed Neo100, a medical device providing continuous feedback on the volumes of air given to the baby during manual ventilation.
Cenova is a full-service contract manufacturer for medical device and single-use products used in the healthcare industry.
We are experts in taking care of the full process for our customers, from product design and development to the distribution of products globally.
Production takes place at our facility in Sweden in one or several of our 22 International Organisation of Standardisation (ISO) classified cleanrooms. Clients, both small innovative companies and large multinational companies, are found across Sweden and in the international market.
Cenova is certified according to ISO 9001, ISO 14001, ISO 13485, and the quality system meet the requirements of the Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 820 QSReg.
Design and development of medical device and single-use products
Cenova is usually involved already at a concept phase of product development. It assures an effective and well serial adopted design, but it also adds more than 40 years of experience in product development.
Cenova can take full responsibility for product development or act as advisers. With capabilities such as 3D printing, mould flow analysis and a fully equipped mechanical workshop, there is a high degree of flexibility in prototype development. From an administration and regulatory perspective, Cenova also assists in the European Conformity (CE)-marking process.
Cenova works according to a standardised industrialisation process called production part approval process (PPAP), assuring that the production process is ready to repeatedly produce serial parts, all meeting customer and market expectations.
A fully equipped mechanical workshop creates necessary tools, fixtures and production aids and automation projects run to scale up production. Cenova’s experience is covering most techniques such as pneumatics, electronics, fibre optics and vision systems.
Plastics as a core competence
Cenova has 11 injection moulding machines ranging from 35t to 300t, placed in a classified cleanroom environment. Cenova also uses thermoforming machines to create blister packs, sealed with materials such as Tyvek.
For plastic components, Cenova can offer all setups ranging from bulk deliveries to complex assemblies. All with the aspect of being produced in cleanrooms. With the fully equipped tool shop, Cenova also offers design and manufacturing of moulds.
Assembly and packaging
While producing plastics components is a core competence, assembly is the largest. During assembly, there is a mix of manual, semi-automatic and fully automatic assembly lines. Cenova works with many standardised assembly processes such as ultra-sonic welding, heat sealing and gluing.
With 16 dedicated cleanrooms for assembly, each room is optimised to fit the customer’s needs. The cleanrooms are individually and continuously monitored both regarding microbiological and particulates contamination.
Packaging of medical device and single-use products
Packaging, packing components or assembled products to retain cleanliness, is a significant part of the Cenova business, with products often sent for sterilisation after production.
Cenova works with many different techniques; most of the time, components in the form of a blister from Cenova’s vacuum forming process is used to create a functional, secure and aesthetically appealing product.
Assuring a sterile barrier over many years is one of the core competences at Cenova, covering seal strength testing and accelerated ageing. Cenova works closely with some of the most recognised sterilisation firms on the market, and most techniques such as E-beam, Gamma, ethylene oxide (EtO) and X-ray is currently part of the responsibility of Cenova.
Logistics and purchasing
Cenova takes full responsibility from order to distribution. Each customer is unique and Cenova adopts the set-up to match each customer need.
Cenova also takes responsibility for the supply chain, since many of the supplied components such as cannulas, needles and tubing are critical for the product, working with a wide range of suppliers worldwide.
Cenova belongs to the Gepe Group. The group is active in five business units: skincare at work, medical devices, plastic components, photographic accessories and animal identification.