Class 7 Certified Injection Moulding Capability
Our dedicated Class 7 Injection Moulding Cleanroom provides the optimum environment to produce complex, high quality, clean medical and biomedical components to meet the needs of our pharmaceutical, drug-delivery, medical, surgical, laboratory and healthcare customers.
Our class 7 injection moulding environment differs in several ways from our main moulding machinery factory floor. Machine operators and engineers enter the room fully covered in body gowns, shoe covers, masks and hair covers. To maintain a strict particulate matter count and guarantee air purity the cleanroom uses positive air flow. Packaging materials are also controlled in the cleanroom to avoid the introduction of additional particles, plastic packaging and specialist coated cardboard is commonly used to manage this.
We design, tool, manufacture, assemble and pack, assisting at every production process stage from prototype and tooling through to small batch runs or full manufacture.
Commitment to Investment
Continual investment in a clean, controlled environment with advanced medical device manufacturing equipment and tooling enables us to remain highly competitive and demonstrates our commitment to improving standards and technology.
Strict quality standards are at the heart of our company ethos
The cleanroom is validated against BS EN ISO 14644 Class 7 specification, HEPA filtered and air conditioned. We are certified to BS EN ISO 13485 for medical and bio-medical device manufacturing and medical assembly.
- BS EN ISO 9001
- BS EN ISO 13485
- BS EN ISO 14001
- Class 7 cleanroom validated to BS EN ISO 14644
- Axiom 900 (Co-ordinate Measuring Machine) for precise and accurate quality batch sampling
Our class 7 cleanroom is an enclosed injection moulding area separated from the rest of the shop floor by hard walls. The air is constantly being replaced, cleaned, and metered to keep particulates in line with the BS EN ISO 14644-1 standard:
- There can be 352,000 particulates >= .5 microns per cubic meter of air.
- There can be 83,200 particulates >= 1 micron per cubic meter of air.
- There can be 2,930 particulates >= 5 microns per cubic meter of air.
The class 7 injection moulding cleanroom is examined and calibrated regularly by a third-party agency to keep its grade.
With strict process controls and robust quality management systems, we offer;
- State-of the-art moulding machines
- Statistical process control (SPC)
- With fully automated machinery, we operate 24hrs/day, 7 day/week for maximum production and efficiency
Our Class 7 Injection Moulding Capability includes;
- A well-established reputation built on solving complex and innovative challenges
- Experienced CAD engineers provide design, prototype and tooling services
- Small batch runs through to full manufacture
- Trained and experienced quality engineers and inspectors
- Dedicated technical team to assist with every project