FTI Incorporation

  Intrinsic particles are defined as those that arise from sources related to the formulation, packaging, or processes. Examples of intrinsic particle materials include glass, stainless steel, rubber from stoppers, and gasket material. Know more about Intrinsic Particulate Matter at FTI Incorporation. What is risk associated with visible particles? There is no published guidance on the potential risk of small numbers of visible particles to patients. Although there is published literature available describing exposure to large numbers of particles, none of these reports reflect the potential hazards of more typical particle administration via large‐ or small‐volume parenteral pharmaceuticals. PDA paper published in Jan 2015 describes four pathophysiological symptoms indicating potential possible harm to patients. 1. Particles may act as a substrate to carry microorganism or endotoxins which may cause Infection and inflammation 2. Leachates from particles may cause inflammatory res...

  The Acceptable Daily Exposure (PDE) is derived based on the full available clinical and non-clinical data and is a dose at which side effects are unlikely to occur if a person is exposed daily for life. by any means at that dose or less. When different medicines are manufactured in shared facilities, the possibility of cross-contamination is an issue. Therefore, the presence of such contaminants must be managed according to risk, which in turn relates to levels that can be considered safe for all population groups. FTI Incorporation is a Permitted Daily Exposure (PDE) Certification Company . The PDE value represents a dose that would be expected to have no adverse effects on a person even with lifetime exposure. This is synonymous with the term ‘Acceptable Daily Exposure (ADE)’. The derived PDE values must be justified with a technical justification so that non-toxicologists (e.g. GMP inspectors) can also interpret and evaluate their content. The general proce...