The ability to manufacture medical devices with consistent high quality relies on well implemented and well documented good manufacturing processes, GMPs.
Europlaz quality control starts from the moment raw materials are introduced, it continues as they are transformed into injection moulded components, and continues through assembly until the final product is packaged and shipped.
As medical device manufacturers we are governed by the US FDA – Food and Drug Administration, BSI – British Standards Institute and the Current Good Manufacturing Process – cGMP, as defined by the Quality Systems Regulation – QSR.
FDA Accreditation
Europlaz has been consistently regulated by the FDA since 1998, Current accreditaions include:
ISO 9001:2008 – Comprehensive management system for design and manufacturing.
This outlines companies must document document all manufacturing processes and demonstrate efforts are in place for continuous improvement.
ISO 13485:2003 – manufacturing inspection and traceability of materials and components
This accreditation is in place in order to demonstrate a company’s ability to provide medical devices that consistently meet customer and regulatory requirements.
ISO 13485:CMDCAS – Canadian Medical Devices Conformity Assesment System.
Cleanroom Quality Control
Each of the three Cleanrooms on site at Europlaz are monitored on a quarterly basis :
Air particulate monitoring in accordance with ISO14644-1:1999 – cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness.
Microbiological monitoring in accordance with ISO14698-1:2003 – Cleanroom and associated controlled environments – Biocntamination control – Part 1 : General principles and menthods.
Micobial monitoring includes passive air sampling(using settle plates) and active air microbial monitoring (using RCS centrifugal air sampler) for bacteria and fungi.
Surface sampling for bacteria and fungi using contact plates is also carried out at various locations and includes work stations, walls and floors etc.
Other essential QC Methods
Cucial to Quality Cotrol at Europlaz is ensuring each member of staff has a thorough knowledge of cGMP and training is consistently up to date. As well as induction training Assembly operators and mould shop assistants have regular refresher training including testing.
Work cards and cGMP guidelines are also displayed prominently throughout the cleanrooms for regular reminders.
Above all, as with all companies complying with good manufacturing processes and FDA guidelines, Europlaz strives for continuous improvement.
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