Mi3’s purpose built assembly clean-room facility is validated and approved to Class 7. This room is designed for precision assembly, manual and automated packaging and in-line testing of critical medical devices.
In addition we have a second clean room where we can provide extrusion of medical grade plastic tubes, injection moulding of components and devices and ultrasonic welding.
Our processes are validated to provide maximum possible assurance of repeatable quality, and we continuously strive to improve these processes with regular training programmes. The manufacture of your critical products could not be in safer hands.
The Mi3 clean rooms are continually monitored to ensure they meet or exceed the requirements of ISO 13485. Particulate counts and Bioburden tests are applied to ensure that the conditions are fully compliant with the manufacture of class I, IIa and IIb sterile medical devices.
Mi3 has the capability to injection mould plastic components within a clean room adjacent to the main assembly clean room. This allows for greater control over the quality and performance of medical device assemblies. In house moulding also gives better control over the cost of critical components. Mi3’s Development and Engineering Teams work with external tool makers to ensure high quality mould tools at appropriate cost.
Mi3 carries out cleanroom extrusion of medical grade thermoplastic tubing. We utilize the best medical grade materials and can tailor the material, size, hardness and colour to your device needs. Our tubing production is housed within our Mach II cleanroom, offering superb levels of hygiene. All our tubing is measured in line, using sophisticated laser systems, and we can print, cut or coil your tubes according to your needs.
Mi3 has invested in Ultrasonic Welding equipment to allow components to be securely welded in a clean room environment. A variety of other welding and assembly processes are also offered, in line with the particular requirements for your device. Our material and process expertise will help us to design quality in and design cost out.
Terminal packaging solutions are critical for your sterile devices, and Mi3 can tailor the right solution to meet your product needs. We can offer a wide range of packaging solutions, from simple peel pouches to fully automated Form Fill Seal lines. Not only will we recommend the most appropriate pack, but we’ll help you design your packaging and transit validations to meet the requirements of ISO 11607 parts 1 & 2.
Our team of experts can help you identify the most appropriate sterilisation method, for your product and our depth of knowledge can fast-track your route to selection of your sterilisation validation pathway. We have a number of live validations which provide us with significant data to assist this process.
Our sterilisation processes include:
– Gamma Irradiation [R]
– Ethylene Oxide [EO]