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:
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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:
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.
EMI is aiming for ISO 13485 certification of its quality management system by 2023.