Pharma corporations that want to operate the US market, have to fulfil very strict regulations. Only by fulfilling these regulations, selling drugs is permitted in the US.
Currently, one of the most important regulations of the FDA (Food and Drug Administration) is 21 CFR Part 11. Users of lab instruments have to comply strictly with the specifications of 21 CFR Part 11. This is only possible, if the manufacturer of the lab instruments offers a 21 CFR Part 11 compliant software.
The white paper available for download, gives insights on how Berghof has implemented the regulations of 21 CFR Part 11 as a software extension for the microwave digestion system speedwave XPERT. From now on, pharma corporations can operate on the US market by using the speedwave XPERT.
Download article (German)
Microwave Digestion for Pharma Analysis
Used Berghof Instrument
Максимальная многовариантность при разложении проб при температурах до 260° C и давлении до 100 bar.