Identification Testing for Visible Particle Defects and Foreign Particulate Matter
At Gateway Analytical, we offer a spectrum of services in the identification testing of visible particle defects and foreign particulates. The first crucial step in the visual inspection lifecycle approach is identifying and testing any visible particle defects and foreign particulate matter. During the inspection process, if any unit is rejected due to visible particles, it should be identified and tracked. These particles can be an early indication of more extensive issues affecting the pharmaceutical manufacturing process.
Leading with Science,
Guided by Expertise
At Gateway Analytical, we understand that the visual inspection lifecycle approach is not just about detecting and removing units that show evidence of visible particulates. It also aims to help companies reduce and eliminate the presence of visible particulates in the manufacturing process. We can assist you in creating good manufacturing processes and environmental controls to minimize particulates.
Your Partners in Particulate Testing
The identification and analysis of visible particles during the visual inspection lifecycle are crucial. Information from this process helps to refine manufacturing procedures and training inspectors to adapt to changing particulate conditions in the production environment.
Additionally, identifying visible particles post-Acceptable Quality Limit (AQL) sampling is vital. This process assesses their impact on the drug product’s quality and patient safety, playing a key role in concluding investigations and determining the suitability of materials for clinical or market release, especially when particulate matter is detected in drug products. Reach out to learn more about our process!
