Achieving ″Zero″ Defects for Visible Particles in Injectables
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
Moreover, there are no size thresholds established to define what is visible; and data is very limited on patient risks associated with particle sizes and numbers. West, a member of Parenteral Drug Association, is participating in an initiative sponsored by the Pharmaceutical Manufacturers Forum to address these shortcomings and develop test methods for assessing the cleanliness of packaging components.1
The journey toward zero defects for visible particles in injectable drug products starts with thorough evaluation of the pharmaceutical and packaging manufacturing processes for sources of particles, and development of methods for their detection and measurement. The goals of this initiative are to establish a definition of visible particles, and to develop test methods to evaluate if they are present. These methods will then be promoted within both the industry and regulatory agencies. This initiative will focus on ready-to-sterilize, ready-to-fill and ready-to-use components. The methods developed will allow component suppliers and pharmaceutical manufacturers across the industry to use harmonized analytical methods for visible particles. Further risk assessment will be performed to identify actions to further reduce particles originating in the supply chain.