“Ready-to-be-used” components are intended to be directly introduced into the Class A clean room area of the aseptic process.
Therefore, the components have to be clean and sterilized before introduction.
EMA CLEAN - CAPS are processed to assure the lowest contamination levels in terms of particulate- and microbial contamination before sterilization.
“Ready-to-be-used” caps are then double-packed into heat-sealed clean room quality PE-bags, followed by a sterilization process through ionizing radiation within their original packaging.
EMA Pharmaceuticals developed a partnership with a renowned specialist in treatments by ionizing radiation. We offer a validated sterilization process by gamma-irradiation, with a re-validated shelf life and packaging integrity of more than 3 years.