We develop and validate our sterilization and dry heat depyrogenation services on a case-by-case basis, achieving a probability of a non-sterile unit (PNSU) and a sterility assurance level (SAL) of 10-6 and a ≥ three log reduction of endotoxin .
Development and validation services are available as per current good manufacturing practices (cGMP) on a custom basis. Containers and stoppers are thoroughly washed with USP/EP Water for Injection and certified to be pyrogen-free and to meet the requirements of the USP for very low levels of particulates.
Terminal sterilization for products manufactured aseptically is available using the bioburden approach to achieve a SAL of 10-6cGMP in the Air Over Pressure Moist Steam Heat Sterilizer.
St79 testing for sterilization of complex orthopedic medical trays in hospital wrap or rigid containers under minimum and maximum load conditions is performed in our GMP compliant moist heat steam sterilizers.
To learn more, please call us at (973) 227-6882.