(695a) Application of Visible Particulate Controls for Long-Acting Nano Suspension Pharmaceutical Products

All injectable products are required to be practically free of visible particulates. This is commonly achieved in solutions by passing the drug product through a 0.2 mm sterilizing grade filter just prior to filling. However, when a product consists of API particles in suspension that would immediately clog such a filter, a more holistic process approach is required to provide a level of assurance that the drug product suspension is practically free of visible particulates and microbial organisms while maintaining API content. To achieve this level of assurance everything entering the process must be considered. Areas of attention include API solution filtration prior to crystallization in drug substance, water activity in the API, 0.2 mm filtration of excipients once dissolved, API handling, API irradiation, closed processing, hold time, hold temperature, visible particulate filter with retention of 150 mm particles and above for suspension filtration, and terminal sterilization have been used successfully to deliver an industrial scale product.