Technical | Compliances & Guidelines

The Ultracentrifuge equipment is fabricated in a modern plant, under the control of a quality assurance system. All equipment is designed to make it possible to manufacture cGMP (Current Good Manufacturing Practice) compliant products as described in 21 Code of Federal Regulations, Parts 210 and 211.

Technical compliance

The Ultracentrifuges are CE certified and have a standard protection rating of IP54.

The control software meets the requirements of 21 CFR part 11 and GAMP.