Manufacture

We manufacture our devices and reagents in accordance with GMP and ISO 9001. All stages of the manufacturing process such as batch manufacture, filling, labelling and packaging are subject to rigid in-process controls. Our products comply with the basic requirements of Directive 98/79/EC and carry the CE mark. High-quality raw materials from well-known suppliers are used for batch manufacture. This ensures that batches remain homogenous and have a long shelf life.
A computer-controlled filling machine guarantees high-precision filling of reagents into round cuvettes. Random samples taken at regular intervals to check the filling gravimetrically on a calibrated electronic check scale.

The end of the quality assurance process is formed by a final inspection that checks all aspects of the finished product. Only goods that meet the specified quality requirements are released for sales.