Injection moulding of medical devices
An injection moulding area to guarantee your clean production…from idea to safety.
Our 350 m² grey zone integrates a complete process under ISO 8 laminar flow, allowing us to reach a level of cleanliness 100 times higher than in a traditional injection moulding workshop.
The objective of the grey zone is to significantly reduce the risk of contamination of injected moulded or assembled products by:
- a physical delimitation of this space from the industrial workshop
- regulation of incoming/outgoing flows thanks to distinct airlocks for personnel and equipment
- access limited to authorised personnel only, duly trained in compliance with cleanliness standards and good manufacturing practices
- restricted access for contaminating materials and equipment (wooden pallets, cardboard, tools from the industrial workshop, etc.)
- adapted and reinforced cleaning of processes
- a specific design of the injection moulding tools as far as the steels and surface treatment are concerned to avoid any grease or impurities
- feeding of raw materials via a dedicated centralised conveying system to avoid contamination by other materials
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Our grey area is also equipped with a complete injection and assembly process in an ISO 8 clean environment. This clean area imposes strict rules on hygiene, dressing of authorised personnel and product input/output, thus cleanliness and classification are regularly checked and standardised in this area.
The installation of the grey zone therefore makes it possible to achieve cleanliness levels and to comply the needs of demanding productions.
From the very beginning of medical device projects, quality management is involved to ensure the safety of these products through:
- the specific design and validation of injection moulding tools
- the qualification protocol for products and manufacturing processes according to IQ/OQ/PQ standards
- the development of test protocols that meet the requirements of the clean environment
- the elaboration of the specific quality documentation related to the batch release
In the context of these demanding productions, the behaviour and commitment of the staff is essential to the success of the projects and to guarantee reliable production. For this purpose, we rely on a comprehensive programme of continuous training and upgrading of our teams on good manufacturing practices , product control practices and in the proper preservation of the production areas.
Since 2024, EMI has been ISO 13485 certified.
- Complete ISO 8 process under laminar flow
- Assembly in a clean, controlled environment
- 4 injection moulding machines including 1 under laminar flow
- Dedicated centralised conveying system of raw material
- Regulated access
- Management of input and output flows
- 1 ISO 8 mobile room