Cleanroom & Quality Systems
At our research facility in Weesp we operate a validated class D cleanroom facility equipped with a class C laminar flow cabinet. Our cleanroom facilities are furnished to produce pharmaceutical grade materials using supercritical fluid technology – a highly unique set-up. The facilities are equipped with a batch extractor and fractionation column for the purification or isolation of APIs from complex mixtures. In addition we offer a variety of particle engineering techniques under cGMP conditions, including SAS (Supercritical AntiSolvent), RESS (Rapid Expansion of a Supercritical solution) and CO2 spray drying.
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Furthermore, a cGMP based quality assurance system with all the appropriate quality system policies and required procedures is in place. Our cGMP facilities regularly undergo internal and external auditing to ensure compliance and assess efficiency.
