Commonly used for creating high-precision plastic components for medical, electronics, pharmaceutical and aerospace industries, clean room injection moulding is a specialised procedure. This blog will discuss what cleanroom moulding is and why it is critical for medical injection moulding specifically.
What is clean room moulding?
Clean room moulding is the production of plastic components in an environment where contamination from dust, bacteria or other airborne particles is kept to a minimum as the parts are manufactured. The key features of a plastic injection moulding clean room include:
- Creation of a controlled production environment for air quality, humidity and temperature.
- Minimisation of contamination through workers wearing protective clothing and the use of specific air contaminant filters in the production area.
- Ensuring compliance to specific quality, process and environmental industry standards.
- Using specialised equipment to maximise cleanliness during the moulding process.
Why is a clean room important for medical plastic injection moulding?
Although precision is important in any moulding process, when it comes to the medical moulding process, careful control of the surrounding environment is key. To achieve such high levels of control a clean room is used for Injection Moulded Medical Devices. The types of components created in such clean rooms include surgical instruments, implantable and diagnostic devices, drug delivery systems, prosthetics, orthotics and wearable medical solutions.
The use of specialised equipment to ensure compliance – clean room injection moulding machines and production processes are specifically designed to ensure that the cleanliness of the moulding process is put as a priority. Plastic injection moulders need to ensure their clean room processes are compliant with:
- Medical Device regulations 2002 for UKCA Marking
- And for quality compliance (including risk management to ISO 14971 standards, traceability and validation) via ISO 13485 (the international quality management standard for the design and manufacture of medical devices) and GMP for CE-marked medical devices.
The classification of the environment – the cleanliness of the air filtration (HEPA/ULPA), humidity levels and temperature need to be carefully controlled and clean room injection moulding must comply with ISO 14644-1. Different cleanliness levels can be complied with in airborne particle concentration, depending on what is being produced:
- ISO Class 7 (10,000 particles per cubic foot) – This is used as standard for medical device production.
- ISO Class 8 (100,000 particles per cubic foot) – This can be used for less critical applications.
- ISO Class 5 (100 particles per cubic foot) – This is for the production of very sensitive medical components, such as implantable devices.
The correct choice of materials for medical moulding – Medical devices need to be certified with regards to human contact and in some cases able to withstand the sterilisation process.
- ISO 10993 (Biocompatibility Testing) to ensure that the product is safe for human contact.
- Sterilisation standards – for those products that need additional sterilisation, standards such as ISO 11137 for gamma sterilisation and ISO 11135 ethylene oxide sterilisation are important.
Choosing a medical injection moulding company
Choosing the right clean room plastic injection moulder is important to the overall quality and reliability of injection moulded medical devices and surgical instruments. To find out more about the key points to consider when choosing a medical injection moulding company why not read this OGM blog?
Looking for a reliable medical plastic moulder in the UK?
OGM is a leading, UK plastic injection moulder of medical components. 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 – https://ogm.uk.com/contact-us/.