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Certification

Quality comes first, both for carrying out the work as well as the facilities in which these activities are carried out. We conduct our operations in several clean areas, including ISO class 7 clean rooms. A clean room is an environment where the pure air from outside is filtered and the amount of dust particles are reduced to a minimum. The air in our clean rooms is constantly refreshed and filtered through (HEPA) High Efficiency Particulate Air filters. All of our tools, furniture and machinery used in clean rooms are specifically designed and have been manufactured to minimize any chance of possible contamination. Our employees wear clean room clothing, washable coveralls, disposable head caps and gloves. All this is monitored and is recorded in our quality management system.

We are always willing to collaborate about optimizing your processes . We can support you in carrying out validations. Our knowledge and expertise in the field of legislation and certification could be of great support for your business.

Certification

  • ISO 9001:2008; Assembly, filling and packaging of cosmetics, medical devices and nutritional supplements
  • ISO 13485:2012; Assembly, filling and packaging of medical devices
  • de Bereiders has a Manufacturing permit for it's activities in pharmaceuticals
  • Working according to GMP (Good Manufacturing Practise)