cGMP Sterile API Manufacturing
Dalton offers the manufacturing of sterile cGMP APIs by a variety of methods including sterile filtration and dry heat sterilization. Our sterile product manufacturing capabilities include sterile filling of powders, liquids and lyophilization.
Production of sterile APIs is a highly specialized capability not widely available in the industry. The manufacture of sterile API’s must be strictly controlled in order to minimise the risk of contamination with micro-organisms, endotoxins and particles.
At Dalton, we have successfully managed to develop compliant sterile APIs for a wide range of molecule types and applications.
Our manufacturing, packaging and testing for sterile APIs follows GUI-0104 “Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API) and ICH Q7 GMP’s for APIs.
Our sterile API teams have more than a decade of experience with creating the appropriate conditions for the media fill and process validation. They are highly flexible and adaptable and will work with you throughout development and scale-up to manufacturing of your sterile API.
Our manufacturing, designed and validated for sterile operations, uses a system of airlocks and cleanroom zones from class D to class A.