Europlaz provides a complete solution for all your contract manufacturing needs. Medical devices and components are designed, manufactured and assembled to the highest standard in class 10000 cleanrooms. (class 7)
Europlaz have specialised in injection moulding and assembly of high quality medical devices since 1975. Complete, cost effective, manufacturing solutions and are our main priority. We are able to create a tailor made manufacturing process to suit each client and product. All manufacture is compliant with ISO 13485:2003 and BS EN ISO 9001-2008.
Experts at Europlaz are available to discuss new medical device ventures as well as looking at ways to reduce costs/manufacturing time of products you already have in production.
Three class 7 medical device assembly cleanrooms.
We are committed to meeting ISO 13485, FDA and GMP standards at all times and ensure we have a dedicated, proficient team of assembly operators.
A wide range of assembly machines are available within the cleanrooms including Ultra-sonic welding, hot plate welding, Adhesive & UV bonding and packaging machines.
Europlaz has over 30 years medical device assembly experience and can create assembly teams and processes specific to your exacting needs.
Of our 22 injection moulding machines, 12 are located in a Class 10,000 cleanrooms, accredited to ISO 14644-1 Class 7. These machines are used solely for the manufacture of medical and pharmaceutical applications where hygiene is of paramount importance. We also work with partner tool-makers who are able to supply very cost competitive tooling, project managed by Europlaz Technologies to ensure that manufactured parts conform strictly to customer specifications. processes of continuous assesment of your moulding efficiency are in place at Europlaz.
An in-house, custom design and build service provides the design, development and manufacture of medical devices and consumables for pharmaceutical and diagnostic companies. Europlaz will work with you to meet individual requirements for specific drug package or diagnostic test and we will manage design of all tooling and testing as needed.
Design services available include:
1. Component design: full 3D / 2D, part design reflects manufacture and assembly parameters.
2. Polymer selection
3. Mould flow analysis
4. Rapid prototype model manufacture, by means of:
* Steriolithography, SLA & SLS.
* High speed CNC machining.
* Vacuum casting (polyurethane).
* Vacuum forming.
5. Prototype mould tool design, aluminium or steel.
6. Single or multi-cavity mould tool design, including hot runner systems, robotics, where required.
7. Multi-cavity tool design for medical components manufactured in clean rooms
8. Design assessment of existing tools, with suggestions to improve, or extend tool longevity
Quality Control is the foundation of Europlaz Technologies' business. We pride ourselves on our systems and processes. The Europlaz Quality Management Team provide a comprehensive regulatory service and compliance.
ISO 13485: 2003
Class 10,000 cleanrooms accredited to ISO 14644-1 Class 7
As a result of continuous expansion and demand from clients for completely integrated and bespoke medical device manufacturing, Europlaz has expanded cleanroom facilities yet again.
The new cleanroom is 4,000 square foot and contains one of the largest injection moulding machines in a clean room in the UK – a 300 Tonne Krauss Maffei machine. Our cleanrooms are equipped to mould, assemble and package class I and II medical devices.
Our three cleanrooms are accredited to highest standard; all manufacture is compliant with ISO 13485:2003 and BS EN ISO 9001-2008.
Europlaz consistently strives to keep up to date with the most efficient manufacturing processes and facilities. We are able to create a tailor made manufacturing process to suit each client and product.
We love a challenge, so call today and ask us how we can help you.