for the bio-sciences sector
We are pleased to announce our newly commissioned Class 10000/ ISO 7 cleanroom at our research facility at Milton Park, Oxfordshire. This level of classification enables us to ensure low air particulate manufacturing that meets the medical device industry’s most stringent production standards. Together with our EN ISO 13485:2012 quality management system, our new cleanroom enables us to manufacture (e.g. single-use) medical devices with reduced and known levels of bio-burden – an essential requirement for successful sterilisation.
Cleanliness of the cleanroom environment is maintained through routine cleaning of all walls, floors and surfaces, together with a HEPA air filtration system. The purpose of the HEPA filter is to drastically reduce levels of dust, airborne microbes and aerosols in the cleanroom atmosphere. The actual level of particulates and microbes in the cleanroom is measured using special equipment and a strict routine of regular monitoring. Anyone wishing to enter the cleanroom is specially trained in hand washing procedures and has to follow a strict code of behaviour. We are also required to change into protective clothing consisting of coveralls, gloves and booties.
Here at Oxford Optronix, one of our key priorities as a company is to deliver quality compliance at every step of the manufacturing process. We believe this Class 10000 Clean Room confirms our commitment to designing, manufacturing and delivering innovative medical devices to our customers that also offer the highest levels of quality assurance.
For a sneak peek inside the cleanroom, and a chance to see some of our employees in their laboratory bests, take a look at the images over on our Facebook page.
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