FTI is global pioneer in customized visual inspection challenge set supply for every kind of sterile product.
Indian firm incubated at National Forensic Sciences University (Institute of National Importance), Gandhinagar campus. We are focused on technological development and rapidly translating technologies from lab to commercial scale. With a deep industry expertise, our products and services are addressing the most advanced and uncommon segments of Pharmaceutical sector, Core Forensics. Forensic Technological Innovation is a Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India recognized company.
FTI is an Indian firm incubated at the National Forensic Sciences University (Institute of National Importance), Gandhinagar. We translate research into commercialscale products for the pharmaceutical sector, with deep expertise in visual inspection and container closure integrity. FTI is recognised by the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India.
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A Knapp Test Kit is used to qualify and validate visual inspection processes for parenteral (injectable) products. Built on the Knapp–Kushner methodology referenced in USP <1790>, it provides a defined population of containers with known defects and established detection probabilities, so manufacturers can measure how reliably manual inspectors, semi-automated stations, or AVI machines detect particulate matter and container defects.
A characterized set of defective containers (vials, ampoules, prefilled syringes, or cartridges) with known defects such as glass particles, metal fragments, fibers, and fill or cosmetic defects; a matched set of acceptable containers; a Probability of Detection (PoD) value for each unit; documentation covering defect classification, Reject Zone Efficiency data, and qualification certificates; and UV coding for traceability.
Yes. Under USP <1790>, visual inspectors must be formally qualified before routine inspection, and the Knapp methodology provides the statistical basis for that qualification. Inspectors are assessed against the kit's known-probability containers to confirm their detection performance meets acceptance criteria, aligned with USP <790>, USP <1790>, and EU GMP Annex 1.
RZE is the core metric of the Knapp test. It compares an inspection process against a manually-established baseline using the same known-probability containers; the process is acceptable when its efficiency meets or exceeds that baseline.
USP <790> requires injectables to be essentially free of visible particulates, and USP <1790> describes how to qualify the inspection process. USP does not mandate a specific commercial kit, but a Knapp Test Kit is the recognized tool for performing that qualification.
