FTI Incorporation: Your Trusted Partner in Knapp Kit Production and Visual Inspection Solutions
Welcome to FTI Incorporation, a premier producer of Knapp kits dedicated to delivering high-quality solutions for the pharmaceutical and biotechnology industries. With years of expertise, we have established ourselves as a trusted Knapp Kit Manufacturer, known for precision, reliability, and strict adherence to global regulatory and visual inspection standards.
We specialize in a wide range of Knapp kits, including:
- Ampoule Knapp Kit
- PFS Knapp Kit
- Cartridge Knapp Kit
- Vial Knapp Kit
- Lyophilized Knapp Kit
- Polypropylene Container-Based Knapp Kits
Our mission is to provide clients with cutting-edge solutions that enhance visual inspection and defect kit to qualify visual inspector performance, ensuring product safety and regulatory compliance.
The Importance of Knapp Kits
Knapp kits are critical tools in pharmaceutical quality control. They help manufacturers
verify the integrity, safety, and compliance of packaging components before products reach
patients.
As a leading Knapp kit producer, FTI Incorporation delivers validated kits that comply with
international standards such as NIST, ISO, GMP, and visual inspection guidelines India.
By Choosing FTI, You Gain:
- Reliable and traceable inspection results
- Faster turnaround for quality assurance processes
- Reduced risk of contamination and defective product release
- Assurance of compliance with global regulatory expectations
Knapp Kits and USP <1790> Compliance
Knapp kits play a vital role in supporting compliance with USP <1790> – Visual Inspection
of Injectable Products. This guideline establishes best practices for detecting defects in
injectables and emphasizes risk-based, lifecycle-driven inspection programs. FTI also
supports USP 1790 Compliance Testing India through standardized and validated inspection
kits.
At FTI Incorporation, our kits are designed in accordance with USP <1790>, ensuring clients
meet current regulatory expectations and complete USP 1790 Compliance Testing India
efficiently.
USP <1790> Highlights:
- Lifecycle Approach – Kits are integrated across development, qualification, and routine inspection phases.
- Defect Library Standardization – Our pre-qualified kits provide consistent references to train, qualify, and requalify human inspectors.
- Inspector Qualification & Requalification – Kits support training and visual inspection and defect kit to qualify visual inspector activities to reduce human error.
- Control of Subjectivity – Validated kits minimize variability in inspection performance.
- Risk-Based Methodology – Kits support threshold studies, POD (Probability of Detection) evaluations, and false positive/negative assessments.
Benefits of Integration:
- Establish and maintain a robust defect reference set compliant with USP <1790>
- Improve consistency in visual inspection standards
- Support inspector training, qualification, and requalification workflows
- Reduce regulatory risk and audit observations.
Manufacturing Excellence
All Knapp kits are manufactured under controlled conditions using ISO Class 5 (Class 100) cleanroom environments and are supplied with full traceable documentation, including:
- Microscopic defect images
- Size and classification sheets
- Validation and calibration certificates
- Expiry information (3 years)
- Training and usage documentation
Knapp Kits for Automated and Manual Visual Inspection
FTI Incorporation offers Knapp Test Kits engineered for:
- Automatic Visual Inspection Machine Qualification India
- Manual Inspector Training & Qualification
Each kit includes NIST-traceable certified defect containers with a range of critical and major defects (fiber, particle, crack, cosmetic damage, etc.).
These are used for:
- Initial inspector qualification and requalification
- POD (Probability of Detection) studies
- AVI system sensitivity verification
- Compliance with USP <1790> §5.5 & §5.6 inspector qualification requirements
Our kits are calibrated under ISO Class 5 cleanroom conditions, ensuring high accuracy and reproducibility for Automatic Visual Inspection Machine Qualification India.
Inspector Qualification Programs
We support structured inspector qualification programs that include:
- Training on defect types (intrinsic, extrinsic, inherent)
- Familiarization with lighting and ergonomic factors (USP <1790> §5.3)
- Benchmarking with visual inspection and defect kit to qualify visual inspector programs to establish detection thresholds
- Meeting minimum detection probabilities (typically ≥80%) as recommended by USP <1790>
Our programs are designed to help organizations develop certified visual inspectors India who can perform reliable, reproducible, and regulatory-compliant inspections.
AVI System Qualification and Validation
We help clients qualify their Automatic Visual Inspection Machine Qualification India systems by providing:
- Defect kits with known POD baselines
- Standardized inspection protocols (§6.1 of USP <1790>)
- Validation documentation (IQ/OQ/PQ)
- Reproducibility, false reject, and false accept studies
Our expertise ensures AVI systems achieve reliable defect classification in line with visual inspection guidelines India and global regulatory expectations. This also supports the creation of certified visual inspectors India through validated qualification processes.
Particulate Contamination Testing
Particulate contamination remains a leading cause of injectable product rejection.
FTI Incorporation provides:
- Visual inspection standards for particle detection
- Quantification of visible particles under 10,000–15,000 lux lighting (per USP <1790> §5.4)
- Root cause investigations (formulation, packaging, environmental sources)
All testing is aligned with USP <790> (Visible Particulates) and integrated with USP <1790>
risk-based inspection approaches. Our particle contamination testing India service ensures
compliance with regulatory expectations and helps minimize risks in injectable product
quality.
We also conduct particle contamination testing India to ensure products meet both domestic
and international quality requirements.
Why Choose FTI Incorporation?
Partnering for Compliance, Quality, and Confidence in Visual Inspection
1. Regulatory-Driven Quality Assurance - Every Knapp kit is designed in line with USP <1790> requirements and validated for full traceability, reproducibility, and compliance with global agencies (FDA, EMA, WHO PQ). Our USP 1790 Compliance Testing India and visual inspection guidelines India ensure every solution meets regulatory expectations.
2. Industry-Leading Technical Expertise - Our team includes certified visual inspectors India, quality auditors, and POD analysts. We guide clients through inspector training, POD study design, AVI validation, and regulatory readiness.
3. End-to-End Visual Inspection Solutions - From certified ampoule and vial kits to AVI qualification, POD analysis, and inspector training, FTI provides a complete solution for risk-based inspection programs, including particle contamination testing India and visual inspection standards compliance.
4. Client-Focused & Customizable -Our solutions are modular, scalable, and tailored to your specific product formats, inspection environments, and regulatory pressures. We provide long-term collaboration, requalification support, and audit readiness services.
At FTI Incorporation, we are your strategic partner in achieving inspection integrity, regulatory compliance, and product safety. Whether you need an ampoule Knapp kit, prefilled syringe validation kit, or USP 1790 Compliance Testing India service aligned with visual inspection guidelines India, we are here to support every stage of your visual inspection standards and quality lifecycle.
Frequently Asked Questions
A Knapp Kit is a validated reference set comprising known defect standards used for the qualification, training, and performance verification of visual inspection processes in pharmaceutical manufacturing. Designed for containers such as ampoules, vials, pre-filled syringes, and cartridges, these kits support both manual and automated visual inspection systems in accordance with USP <1790> guidelines.
The Knapp Test is a systematic evaluation method utilizing defect standards to assess the visual inspection capabilities of personnel or automated systems. It involves presenting known defect samples under controlled conditions to verify detection sensitivity, consistency, and compliance with regulatory expectations.
The Knapp-Kushner Method is a structured visual inspection training and qualification approach using defined defect libraries. It standardizes human inspector assessment through controlled challenges, improving detection reliability and aligning with the lifecycle-based inspection strategy recommended in USP <1790>.
To conduct a Knapp Test: Prepare a validated Knapp Kit with certified defect samples. Use a controlled, ISO 5-compliant inspection environment with standardized lighting. Conduct inspections at prescribed distances and durations, as per SOPs. Record inspector responses, calculate detection rates, and assess qualification based on predefined acceptance criteria.
Kit inspection refers to the periodic verification of the integrity, completeness, and calibration status of a Knapp Kit. This ensures all defect samples remain representative and usable for training, qualification, and system challenge purposes.
The Knapp Test Protocol defines the standard operating procedure for executing defect detection exercises using a Knapp Kit. It includes guidelines for kit usage, defect classification criteria, inspection environment controls, inspector evaluation methodology, and data documentation, as recommended under USP <1790>.
A Defect Kit is a curated set of pharmaceutical containers intentionally embedded with known visual defects (e.g., particulate matter, cracks, cosmetic blemishes). These kits are used for inspector training, qualification, and ongoing performance monitoring in line with risk-based visual inspection programs.
Visual inspection of finished pharmaceutical products involves a structured evaluation for visible particulates, container defects, and cosmetic issues before product release. As a final quality assurance step, it ensures conformance to specifications, supporting patient safety and regulatory compliance.
Vial inspection involves the following: Use of controlled lighting (10,000–15,000 lux) without glare. Rotating the vial to check for particulate matter, cracks, delamination, or discoloration. Assessing container closure integrity (CCI). Documenting all observations per SOP and performing trending analysis if required.
This refers to the examination of raw materials or active pharmaceutical ingredients (APIs) for visible contaminants, discoloration, or agglomerates before formulation. Such inspection is a key component of material acceptance and GMP compliance.