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 of Industrial Policy and Promotion (DIPPT), Ministry of Commerce and Industry, Government of India recognized company.
FTI Incorporation (Forensic Technological Innovation) is an Indian firm incubated at National Forensic Sciences University, Gandhinagar campus, focusing on technological development and deep industry expertise to achieve practical results with real impact in the field of Pharmacy, Forensics. This is a spin-off firm from NFSU research labs for transferring academic and industry collaborative research of NFSU into products for the industries. Forensic Technological Innovation Incorporation was founded by National Forensic Sciences University's research team consisting of qualified doctorates and domain experienced people in Pharma, Chemistry and Allied Forensics.
Satisfied Clients Globally
Member team of Experts in Contamination Investigation and Knapp Kit
Types of Injectable Packaging Material converted to Knapp Kits
Years of Expertise
A Knapp Test Kit is used to qualify and validate visual inspection processes for parenteral (injectable) products in pharmaceutical manufacturing. Built on the Knapp–Kushner methodology referenced in USP <1790>, the kit provides a defined population of containers with known defects and established detection probabilities. This lets manufacturers measure how reliably manual inspectors, semi-automated stations, or automated visual inspection (AVI) machines detect particulate matter and container defects — the industry-standard way to prove an inspection process is capable and compliant.
A standard Knapp Test Kit includes: a characterized set of defective containers (vials, ampoules, prefilled syringes, or cartridges) seeded with known defects such as glass particles, metal fragments, fibers, and fill or cosmetic defects; a matched set of acceptable "good" containers; a determined Probability of Detection (Pd) value for each unit, established through repeated manual inspection; full documentation covering defect classification, Reject Zone Efficiency data, and qualification certificates; and traceability features such as UV coding for kit management and audit readiness.
Yes. Under USP <1790>, visual inspectors must be formally qualified before performing routine inspection, and the Knapp methodology provides the statistical basis for that qualification. Inspectors are trained to recognize defect categories, then assessed against the kit's known-probability containers to confirm their detection performance meets acceptance criteria. Proper qualification ensures results are reproducible, defensible in audits, and aligned with USP <790>, USP <1790>, and EU GMP Annex 1.
Reject Zone Efficiency is the core metric of the Knapp test. It compares the detection performance of an inspection process (manual or automated) against a manually-established baseline using the same set of known-probability containers. An inspection process is considered acceptable when its efficiency meets or exceeds that manual baseline, demonstrating the process reliably rejects defective units while correctly accepting good ones.
USP <790> requires that injectable products be essentially free of visible particulates, and USP <1790> describes how to qualify the inspection process that ensures this. While USP does not mandate a specific commercial kit, a Knapp Test Kit is the recognized tool for performing that qualification — providing the characterized defect sets and detection-probability data needed to demonstrate compliance during audits.
