Medical plastic production
We assure you the best facilities for medical plastic production and a high standard of quality.
Medical plastic production
We have for many years served the medical industry with prototypes for medical devices. Responding to a growing customer demand for more parts for development, and later for clinical runs and initial quantities for market, ML made the decision to expand in this area and develop a comprehensive medical production capacity. This expansion started in 2017 and today we have a whiteroom with 9 injection moulding machines, supported by a significant quality department. This decision prompted a focus on quality control and a management system, followed by equipment for measuring parts.
The 9 injection moulding machines are supported by 7 robots, 4 box exchanger systems, multiple tool water heaters up to 180º C and multiple material dryers. Each machine can be equipped with a screw ranging from Ø15mm to Ø35mm, providing substantial flexibility, where we can cover shot weights from micro components up to 110 grams. We have 2 machines with 2-shot capability as well as extensive experience in building tools for 2-shot moulding.
The whiteroom is equipped with an air lock with gowning, a ventilation system providing filtered and cooled air, and overpressure. It is expected that this facility will be Class 9 cleanroom certified by the end of 2023.
The plastic production is prepared for ISO 13485 certification, which we expect to have in place by the end of 2022.
We have extensive experience in conducting validations of different complexities for different customers, so we work with our customers to meet their specific needs. For customers who don’t have their own templates or specific requirements, we have developed our own templates for the Validation Plan, IQ report, OQ report and PQ report. These templates adhere to the stringent standards for comprehensive medical validation while minimising paperwork through efficient use. Included in the OQ report is an SRI (Systematic Running In) and development of a process window, to best secure and define allowable changes during running production.
Typically, our validation processes focus on multi-cavity production tools, however where needed, we can also validate 1-2 cavity tools in the ML Mould Base System, which means that we can provide validated parts for clinical runs with significantly shorter lead times and lower costs than a production tool.
We also have the capacity to generate the FAI report, which can either be included in the validation or done separately.
In terms of documentation, our plastic production follows a stringent flow of requirements; line clearance when changing production in the machine, labelling with batch numbers for material drying, documented start up control, documented control during running production, reference parts stored, machine program saved, process data saved as pdf, and production log saved as pdf. All this documentation is saved on our server under a folder for each production batch. All parts are labelled, no matter where in the production flow they are, and there is never any doubt of which stage they are at, whether they are parts for control, parts controlled, or packed and ready for shipment.
Upon request, we provide a CoA and CoC with the batches when shipped.