Aseptic preparations

HCM Medical’s clean room facilities exists of clean rooms varying from Class C to Class A/B and provides the opportunity for aseptic handling and filling of these products that can’t be terminally sterilized.
Microbiological growth medium is used in place of the product during media fills to test whether the aseptic procedures are adequate to prevent contamination during actual production. A media fill is one part of the validation of an aseptic manufacturing process.
Every six months the trained production team is requalified.