Medical & Paramedical
Directly related to medicine, care, technical assistance or equipment, these two sectors have particular requirements for the manufacture of plastic parts.
EMI participates in the co-development of medical devices, fulfills design request for parts and tooling and carries out functional validation. Produced in a controlled environment, or totally under ISO 8 supervision, these parts can be directly assembled in the workshop and then packaged according to a strict protocol.
CUSTOMER CASE STUDY
Our customer develops specialised products and solutions in the fields of healthcare, life sciences and high-performance materials.
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01 CHALLENGE
For its new medical project, our customer was looking for an injection moulding partner who could guarantee the high manufacturing and traceability requirements in a medical environment.
Its needs also involved the assembly of the complete product, quality testing and packaging in a controlled particulate environment.
02 APPROACH & SOLUTION
The injection moulding of the two parts was carried out within a grey area under a laminar flow process. The 50 t injection moulding machine used is directly connected to a clean room via a robotic system, with the whole system operating under ISO 8 laminar flow.
Both tools, one of which is equipped with an automatic unscrewing unit, have been manufactured in stainless steel to meet the medical and technical specifications of the parts.
To complete the process, operators trained to meet medical requirements carry out visual inspection, assembly, leak testing, tamper evident labelling and double bagging of products in an ISO 8 controlled environment after they have been moulded.
Our 350m² grey area allows the implementation of good practices in a medical environment with, in particular, an operator's airlock, an equipment airlock, specific areas for the entry of components and the exit of finished products. The safety of the parts is therefore guaranteed from their injection moulding to their final packaging.
- ISO 8 process under laminar flow
- 50 t injection moulding machine
- Stainless steel tools
- Automatic unscrewing unit
- Non-destructive leak test
- Assembly in ISO 8 controlled environment
- Operators trained according to medical requirements
- Safety and traceability of plastic components guaranteed
- ISO 13485:2016 standard