Production & Quality
An efficient quality process!
Our products are firstly in-house designed, and secondly produced in our facilities. The industrialization of the products follows several stringent and efficient phases. The quality policy is in the heart of the industrialization and production processes:
- Controls, made upon reception of purchased parts,
- Controls, made upon reception of out-sourced parts,
- Controls of 100% of the products, before shipment,
- Certifications (EN12469), annual calibration of the measurement instruments,
- Out-going control at every step of the production process: assembling, equipment programming, products customizing.
The products are manufactured following high quality procedures. The workshop features mechanical, electrical and final control delimited zones. The manufacture process is performed by highly skilled engineers, experienced in biomedical products.
Noroit uses an efficient Computer Aided Management and Manufacturing System for production processes, stock and part sourcing.
Software programming – custom design of the product:
The embedded software is custom programmed to be adapted to the client’s needs.
Alarms, delays, input – output signals, are configured according to the final application.
The software is developed and tested on a computer, and then downloaded in the apparatus.
Control – Qualifications:
Final controls are completely ensured in-house.
- Pressure and airflow measurement, using an electronic manometer and anemometer,
- Body seal test, using ammonia and a leak detector cloth,
- Air particle cleanliness measurement, using an optical particle counter.
Laminar flow – Safety Cabinets:
- Air cleanliness measurement, using an optical particle counter,
- HEPA filter efficiency control, “DOP” test, using a nebulizer of calibrated 0.3µm particles and a photometer,
- Airflow velocity measurement, using an electronic anemometer to obtain a 3D mapping,
- Outside air induction leak test, using a smoke generator,
- Exhaust airflow control (Class II Safety Cabinets only), using a balometer,
- Operator protection test – air barrier control (Class II Safety Cabinets only), using a nebulizer, a particle counter and an ISO 5 vertical Air Flow Module,
- Sound level measurement, using a sound meter,
- Lighting level measurement, inside the working volume using an electronic lux meter.