Matching regulations and data traceability are crucial in many analytical lab, such as pharmaceutical, nutraceutical or other regulated industries. That's why Milestone offers a comprehensive Milestone Validation Package, that gives access to our factory trained engineers and specialists during the qualification process, enabling a fast implementation of your digestion system in full accordance with Good Manufacturing Practice (GMP) guidelines. Milestone’s operating software, easyCONTROL, is fully compliant with FDA regulation 21 CFR part 11.
The USP chapter <281> describes the methodology for measurement of inorganic contaminants in pharmaceutical samples, where the adopted technique is the Sulfated Ashing. Milestone's PYRO is an advanced sulfated ashing system, that allows to run this particular application in one step only, thus assuring operators’ safety and reproducibility of results.