Cleanroom plastic injection moulding is a specialist process that is used to produce precision manufactured plastic components in a clean and controlled environment. Cleanrooms are designed to prevent contamination that could negatively impact performance or safety. They are used for manufacturing in industries where processes and products are susceptible and sensitive to contamination from airborne particles such as medical devices, healthcare, electronics and aerospace.
Plastic injection moulders that produce components, sub-assemblies and final assemblies for medical device manufacturing will need an ISO 7 Cleanroom, also referred to as a class 10,000 cleanroom. In an ISO 7 cleanroom, the air should contain no more than 2,930 particles equal to or greater than five microns per cubic metre (5 µm).
Cleanroom moulding for medical devices
With medical injection moulding, the entire medical moulding, assembly and packing process can take place within the cleanroom. Injection moulding machinery and equipment is modified to satisfy cleanroom requirements, with additional filters and enclosures to prevent contamination. Air that flows into the cleanroom has to pass through a HEPA (High Efficiency Particulate Air) filter in order to prevent particles that could cause contamination entering the cleanroom.
Plastic injection moulders experienced in moulding components for medical devices, like OGM, work within set guidelines to meet ISO 13485 regulations. ISO 13485 is the international quality management standard for the design and manufacture of medical devices. This includes strict hygiene practices and monitoring and testing of particle and microbe levels.
Injection moulded medical devices
Cleanroom injection moulding is essential for precision components used in the manufacture of medical devices that have to meet strict regulatory compliance and require sterility. Some typical devices and applications include:
- Surgical instruments and implantable devices such as forceps, clamps, orthopaedic implants and stents that will come into direct contact with body tissue need to be made from medical grade and biocompatible polymers.
- Diagnostic devices – housings for monitoring and testing devices and laser scanners
- Drug delivery systems – plastic tubing, connectors, syringe parts, casings for autoinjectors and components for nebulisers and inhalers
- Prosthetics and orthotics – components for limb replacements or support braces
- Wearable medical devices – housings for wearable devices that monitor heart rate, oxygen and glucose levels or provide relief for conditions such as tinnitus and Tourette syndrome.
Choosing a medical injection moulding company
Due to the very specific requirements of components for medical devices and surgical instruments in terms of precision, quality and compliance, it is essential that you are confident in your choice of moulding partner. Here are some key points to consider when choosing plastic injection moulders in the UK.
- Medical industry experience and scope
Choose a moulder that has worked with different types of medical companies and on a range of different applications. Injection moulders that have a good reputation will have worked on a variety of projects and have lots of very specific expertise. They will also have an expansive and efficient cleanroom and technical knowledge about the manufacturing process, material choice, validation procedures and compliance that will save you time and money. - Clean room capabilities
Ask your shortlist of moulders what equipment they have in their cleanroom and the processes they can carry out under cleanroom conditions. If your project will involve lots of manual work, ask about the injection moulding team’s skills and experience. - Certifications
Ensure your partner of choice is certified to ISO 13485 and therefore has a quality management system that is tailored to the medical device industry and, to complement this, ISO 9001 for general manufacturing. In addition, to ensure consistent production quality, ensure they follow IQ, OQ and PQ validation procedures. - Design and customisation
Ask your injection moulder about the design process, the types of intricate or complex designs they have worked on, what the challenges were and how they overcame them. Also, what equipment they have to support rapid prototyping. The answers to these questions will show how innovative and flexible the moulder is at problem solving to meet your design specification, or to improve upon it. - The materials they work with
Check that the material suppliers your medical injection moulder uses quality suppliers that they have a good relationship with so you can be confident they will have the range and availability of medical grade and biocompatible plastics you will need for your project. - Project management and support
Finally, find out how your chosen injection moulder manages its customers projects. How do they assign a team, who will be involved when, what additional services do they offer, what will the timeline look like, how much technical support can you expect and how do they ensure cost, time and waste efficiencies? - Made in Britain
If you are an international business looking for a UK based medical injection moulder, it makes sense to find one that has experience of working with export businesses. In addition to the expertise they will have for producing medical components and assemblies, they will understand your requirements more easily and have systems already in place in terms of logistics and deliveries.
Once you have considered all of the information to satisfy these key factors, you will be in a strong position to choose the best injection moulding company for manufacturing your medical device components.
Looking for a reliable medical plastic moulder in the UK?
OGM is a leading UK plastic injection moulder of medical components. Located in Oxford, a city renowned for its expertise in medical science, OGM has a rich history of working with medical device manufacturers and currently provides plastic injection moulding for leading global brands as well as innovative start-up businesses.
OGM’s ISO 7 cleanroom is equipped with the latest technology including a mix of seven injection moulding machines ranging from 50 ton to 160 ton. OGM has experience of plastic injection moulding components for surgical instruments, laser scanning devices, housings for monitoring devices, syringes and drug delivery systems, connectors, implants and orthopedics. You can find out more about our services by visiting the following URL – https://ogm.uk.com/injection-moulding-services/ or by contacting us directly on 01865 844300.