Applications of cleanroom moulding in critical medical devices and components manufacturing

Without clean room injection moulding, many of the devices we all take for granted wouldn’t exist. This blog will talk through the key applications that benefit from cleanroom moulding when it comes to critical medical devices and components, and why this process is so essential.

Clean room moulding

‘What is clean room moulding?’ Well, cleanroom moulding is used when plastic injection moulders create plastic components and devices that are of a certain level of precision, sterility and biocompatibility. The environment they are produced in complies to a range of industry standards and is primarily free from contaminants such as dust, bacteria and other airborne particles. More details around what clean room moulding is can be found here.

Main applications for cleanroom moulding

Thanks to the precision, high-volume and cost-effective benefits of plastic injection moulding, it is well suited to the creation of components and devices. When combined with a clean room, medical plastic injection moulding spans a wide range of applications:

Medical injection moulding for surgical instruments and tools
Plastic injection moulding is ideal for the creation of surgical instruments and tools because of the processes’ ability to be precise, cost-efficient and versatile. A range of materials can be used, such as medical-grade plastics and high-performance polymers and they can be tailored to suit the end product’s use. From forceps and clamps to endoscopic device components and minimally invasive surgery (MIS) instruments, clean room moulding can be used to create items that are free of particulate contamination.

Creating medical consumables and sterile packaging
Many medical items need to be sterilised, resistant to disinfection and corrosion and meet a wide range of biocomopatibility standards in their daily use. Plastic injection moudling is able to use medical-grade plastics such as PEEK, PPSU, ABS, PC, PP, TPE and Nylon and meet biocompatibility standards such as ISO 10993 and FDA regulations. This is important for items such as test tubes, vials, petri dishes, pipettes and pharmaceutical caps and closures that need to be sterile for patient or laboratory use.

Medical moulding for implantable medical devices
Not surprisingly high precision and consistency are vital in the creation of implantable medical devices. Thanks to the tight tolerances, complex geometries and high volumes of identical parts that are possible with plastic injection moulding, the process is well suited to the creation of pacemaker casings and components, stents, orthopedic implants and drug-delivery systems (eg. insulin pumps).

Producing monitoring and diagnostic equipment
Injection moulded medical devices such as blood glucose monitors and in vitro diagnostic components need to be created in a cleanroom environment, particularly if they are used in microfluidic devices for lab-on-chip diagnostics. Also wearable health sensors benefit from the high-volume, cost-effective consistency that plastic injection moulding brings to production.

Cost-effective fluid management and drug delivery systems
The cost-efficiency benefits of medical injection moulding are also seen in the creation of IV and infusion pumps, syringe components and inhaler and nebuliser parts. Also, by using cleanroom production processes, the risk of contamination is significantly reduced in such drug-dispensing and fluid systems.

Cleanroom moulding is essential

As can be seen, clean room moulding is essential in the creation of medical devices and components because it:
  • Carefully manages microbes, dust and other contaminants that could cause complications in patient care.
  • Ensures that all ISO, FDA and GMP standards are met at all times in the production process and maintains the biocompatibility of medical-grade plastics.
  • Delivers precise and consistent micro-moulded parts at high-volume.

If you are looking for plastic injection moulders in the UK who can deliver high quality injection moulded medical devices and surgical instruments, then talk to OGM. As a leading UK plastic injection moulder of medical components manufacturer, OGM has an ISO 7 cleanroom that is equipped with the latest technology including a mix of seven injection moulding machines ranging from 50 ton to 160 ton and manufactures in accoradance to ISO13485 standards. 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 – https://ogm.uk.com/contact-us/.

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