Medical plastic production

Medical Plastic Production

We have for many years served the medical industry with prototypes for medical devices, and with an increasing customer need for more parts for development purposes and later for clinical runs and initial quantities for market, ML made the decision to expand in this area and develop a full blown medical production to serve these needs. This expansion started in 2017 and today we have a whit room with 9 injection moulding machines supported by a significant quality department. With this decision came also a focus on quality control and 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. Every machine can be equipped with a screw ranging from Ø15mm to Ø35mm giving a very large flexibility, where we can cover shot weights from Micro components and up to 110 grams. We have 2 machines with 2-shot capability and also a large experience in building tools for 2-shot moulding.

The white room 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 end of 2023.

The Plastic Production is prepared for ISO 13485 certification, which we expect to have in place by end of 2022.

Validation

We have a large experience doing validations of different complexities for different customers, so we work with our customer to meet their specific needs. For customers who don’t have their own templates or specific requirements, we have developed our own templates for Validation Plan, IQ report, OQ report and PQ report, which meets the requirement for full blown medical validation, but with minimum and efficient use of “paper”. 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.

Normally it is multi cavity production tools which are being validated, 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 within significant shorter lead time and lower cost than a production tool.

We have the ability to make the FAI report, which can be included in the validation or done separately.

Documentation

The Plastic Production has a stringent flow of documentation requirements; Line Clearance when changing production in the machine, Label with batch no. for material drying, documented Start Up Control, documented control during running production, reference parts stored, machine program saved, Process Data saved as pdf, 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 doubt where in the production flow they are; parts for control, parts controlled, parts packed and ready for shipment.

Where required we provide CoA and CoC with the batches when shipped.