DESIGN AND DEVELOPMENT

INDUSTRIALIZATION

PLASTICS

ASSEMBLY

PACKAGING

LOGISTICS AND PURCHASING

Let our team help you
with your ideas

Cenova is a full-service contract manufacturer. We take care of the whole process, from product design and development to sterilization and distribution of your products. Either you have a finished product and need help with the manufacturing, or an idea that our team develop together with you. Either way, we can be your partner in all steps towards realizing your ideas.

Design and development

  • Product Design and Development
  • Prototypes
  • 3D-printing
  • Optical and probe measurements
  • Tool design and manufacturing
  • Regulatory documentation
  • CE-marking

Involving Cenova early in the development of a new product is the best way to instantly add 50 years of experience of design of sterile products and packaging. Cenova has a history with own patents and own products and is therefore a perfect partner in realizing a new product.

With a standardized way of working we ensure that the development project delivers the outputs that are required regardless of intended market. Cenova is working according to design control as defined in ISO 13485 and 21 CFR 820 and can support in creating required documentation e.g. for a technical file.

Our project managers are used to working closely with the customer. Working closely together creates the foundation to create a product that fulfils market expectations and requirements.

With a large mechanical workshop, we can quickly create mock-ups, prototypes and tooling, a benefit that shortens lead times and results in efficiency when working with concept design and design solutions.

Industrialization / Design transfer

  • Process flow chart analysis
  • Process risk assessment
  • Tools, Fixtures and Equipment’s
  • Vision systems
  • Automation and Optimization
  • Qualification and Validation

Since 2015 Cenova has worked according to the standardized PPAP-process, since many years the standard in the automotive industry. It stands for Production Part Approval Process and includes defined steps to prepare a product to be launched into production.

Working according to PPAP assures that the production process is ready to repeatedly produce serial parts, all meeting customer and market expectations.

Together with a formalized process to introduce new products to production, Cenova have 50 years of experience in reviewing designs to optimize them for an efficient production.

Above is accompanied by technicians with competence in pneumatics, electronics, fibre optics and vision systems, which creates a solid background and foundation to in-house create the fixtures, tools, test equipment’s etc. needed to run an efficient production line.

It is all about plastics

  • Tool design and manufacturing
  • Mold flow analysis
  • Injection moulding, 35 tons to 300 tons
  • Thermo formed components/blisters
  • Tool design for thermo forming and injection moulding
  • Full care service of tools

Even though Cenova is a full-service contract manufacturer it is still all about plastics. This is where it all began, and injection moulding and thermo forming are still considered as core processes at Cenova.

Cenova have 14 injection moulding machines ranging from 35 tons to 300 tons, varying between horizontal/vertical and hydraulic/electrical, all placed in a classified clean room environment. In line with a focus on efficiency and lean manufacturing robotics is often used to automate our processes.

Cenova is also one of few companies in Sweden which offers thermo formed blisters from a classified clean room environment. Products which vary from being used as sterile barrier together with a Tyvek lid to transportation plates for cannulas and mixing plates for in-vitro diagnostic devices.

Cenova also possesses a large mechanical workshop which is used to service and maintain all tools. Cenova can also repair or adjust existing tools e.g. because of a design change and can manufacturing new tools.

Involving Cenova early in the component development will secure a fast and efficient road to the final design. We can support with the whole spectrum from mold flow analysis to Luer design and testing according to ISO 80369-7.

Assembly

  • Manual and semi-automatic assembly
  • Collaborative robots
  • Quality testing
  • Heat sealing
  • Gluing
  • Ultra-sonic welding
  • Visual control
  • Labelling

We love adding value to our customers. That is why we not only want to produce plastic components but also add assembly, labelling and packaging of complete products.

Cenova has 16 ISO class 7 classified clean rooms and offers a variety of different processes. From manual and semi-automatic to fully automatic assembly processes in which the products are also tested and quality assured.

A variety of critical sub processes are also operated. Ultra-sonic welding is used to weld two plastic components together by ultra-sonic sound. Gluing in different forms is used in many different applications. With the capacity of separate clean rooms, we can optimize each room to fit our customer’s needs. The clean rooms are individually and continuously monitored both regarding microbiological and particular contamination. All monitoring is documented in room specifications enabling full control of each room.

Cenova has implemented lean manufacturing (under the name Clean) and we are constantly driving our processes to become more efficient. By having an in-house work shop Cenova has the capacity to design and manufacture fixtures and equipment to automate our production processes. Together these strengths enable us to make our customer’s products competitive and ready for new and increasing market shares.

Packaging and sterilization

  • Packaging solutions
  • Sterile barriers
  • Seal testing, pull force strength testing etc.
  • Ageing testing (accelerated and real time)
  • Sterilization services – Ethylene oxide EO / gamma / E-beam (beta) and X-ray
  • Dose mapping and Dose audits
  • Microbiological control
  • Particulates / Particles control
  • Endotoxin control
  • ISO 14644 and ISO 14698

Many of Cenovas customers have specific requirements on cleanliness on the product released to the market. Often it is linked to a requirement on sterility. Cenova therefore have established partnership with many of the biggest actors when it comes to sterilization. In order to secure sterility a sterile barrier in form of av primary packaging is needed. Cenova is working with many different techniques and most of the times components in form of a blister from Cenovas vacuum forming process is used to create a functional, secure and aesthetically appealing product.

Welding is a core process at Cenova where it is as important to create a seal as to keep the function of being easy to open. Cenova has long experience in designing a qualifying packaging and sterile barriers. This is done by working with several international standards such as ASTM F1886, F1929, F1980, F2096, F88 as well as ISO 11607-1, ISO 15378, EN 868-X etc.

Since a couple of years Cenova is also working close with STERIS – a leading provider of infection prevention and other procedural products and services. Cenova use STERIS for laboratory services and sterilization. (www.steris.com)

Cenova also have long experience when it comes to secondary packaging. The packaging pattern must comply with the chosen sterilization method as well as fulfilling requirements linked to transportation. With a large scale of standardized packaging solutions we make sure that this part of the product design is not forgotten and that it is done right from the beginning.

Logistics and Purchasing

  • A wide range of suppliers worldwide
  • Established cooperation’s with leading sterilization and microbiological services
  • Supplier assessment and evaluation
  • Transport of your product to any destination
  • Storage and shipment of your sterile product to end user

Cenova will make sure to manage suppliers and ensure that our customer’s products include components and material that are compliant with regulations and meet your specifications. Cenovas also applies a general code of conduct for our suppliers. Found here.

We take full responsibility from order to distribution and will make a unique setup depending on the customer needs.

We have a wide range of suppliers and partners for sterilization, components and everything else needed to produce and deliver your product.