FTI Incorporation: Your Trusted Partner in Knapp Kit Production and Visual Inspection Solutions
Welcome to FTI Incorporation, a premier producer of Knapp kits committed to delivering high-quality solutions for the pharmaceutical and biotechnology sectors. With years of industry expertise, we have established ourselves as a trusted Knapp Kit Manufacturer, known for our reliability, precision, and adherence to regulatory standards.
We specialize in a diverse 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 streamline visual inspection and defect testing, ensuring product safety and regulatory compliance.
The Importance of Knapp Kits
Knapp kits are vital tools in the quality control process, helping pharmaceutical manufacturers ensure the integrity, safety, and compliance of their packaging components. As a leading Knapp kit producer, FTI Incorporation is committed to offering reliable, validated kits that meet international standards, such as those set by NIST, ISO, and GMP regulations.
BY CHOOSING FTI, YOU’RE ENSURING:
- Reliable and traceable inspection results
- Faster turnaround for quality assurance processes
- Reduced risk of contamination and defect release
- Compliance with regulatory authority expectations
The Importance of Knapp Kits in Compliance with USP <1790>
Knapp kits are essential tools in supporting pharmaceutical manufacturers’ compliance with USP <1790> – Visual Inspection of Injectables, which outlines best practices for detecting Visual inspection standards in injectable products. At FTI Incorporation, we design our Knapp kits in accordance with this guidance, ensuring that our clients meet current expectations for risk-based, lifecycle-driven visual inspection programs.
USP <1790> emphasizes:
- Lifecycle Approach to visual inspection—Knapp kits are integrated throughout the development, qualification, and routine inspection phases.
- Defect Library Standardization—our kits provide pre-qualified Visual inspection standards in relevant containers to help train, qualify, and periodically challenge human inspectors.
- Inspector Qualification & Requalification—our kits support regular training and visual acuity checks as required by USP <1790> to minimize human error.
- Control of Subjectivity—using consistent, validated Knapp kits reduces variability in inspection performance and strengthens data integrity.
- Risk-Based Methodology—FTI's kits are designed with typical and Visual inspection standards to support threshold studies, detection capability evaluations, and false positive/negative assessments.
By integrating our Knapp kits into your visual inspection process, you can:
- Establish and maintain a robust defect reference set compliant with USP <1790>
- Improve consistency in Visual inspection standards
- Support inspector qualification, requalification, and training workflows
- Minimize regulatory risk and audit observations related to visual inspection
FTI Incorporation ensures that all Knapp kits are manufactured under controlled conditions, using Class 100 (ISO 5) cleanroom environments, and come with traceable documentation including:
- Microscopic defect images
- Size and type classification sheets
- Validation and calibration certificates
- Expiry information (3 years)
- Additional training and usage documentation
Visual Inspection & Qualification Services
Supporting USP <1790> Lifecycle Approach for Injectable Product Integrity
USP <1790> – Setting the Standard for Modern Visual Inspection
As per USP General Chapter <1790> "Visual Inspection of Injections", visual inspection is not a one-time activity—it is a life-cycle-based process involving method development, inspector qualification, POD (Probability of Detection) studies, defect kit management, and ongoing performance verification. At FTI Incorporation, all our services, tools, and training systems are aligned with these core principles to help our clients in India meet global regulatory expectations, including those from the US FDA, EMA, and WHO.
Knapp Test Kits for Inspector & AVI Qualification – India
We offer Knapp Test Kit for AVI India engineered for:
- Certified Visual Inspectors India
- Automatic Visual Inspection Machine Qualification India
Each kit contains NIST-traceable certified defect containers, representing a range of critical and major defects (e.g., fiber, particle, crack, cosmetic damage). These are used for:
- Initial Inspector Qualification & Requalification
- POD (Probability of Detection) Studies
- AVI System Sensitivity Verification
- Visual Inspection and Defect Kit to Qualify Visual Inspector (per USP <1790> §5.5 & §5.6)
- Supports qualification per USP <1790> Table 3: “Minimum Requirements for Inspector Evaluation Programs”
- Calibrated under cleanroom ISO Class 5 / Class 100 conditions
Certified Visual Inspectors in India
Our visual inspectors are qualified through a structured program that incorporates:
- Training on defect types (intrinsic, extrinsic, inherent)
- Familiarization with environmental lighting and ergonomic factors (USP <1790> §5.3)
- Use of Visual Inspection and Defect Kit to Qualify Visual Inspector threshold benchmarking
Each inspector must meet defined detection probabilities (typically ≥80%) as per USP <1790> recommendations to be qualified.
Automatic Visual Inspection Machine Qualification India Machine Qualification
We help you qualify AVI systems by:
- Supplying defect kits with known POD baselines
- Designing Visual inspection standards §6.1 for system validation
- Supporting validation documentation (IQ/OQ/PQ)
- Conducting reproducibility, false reject, and false accept studies
Our team ensures the AVI system achieves reliable defect classification with proven POD metrics that meet or exceed regulatory expectations.
Particle contamination testing India (USP <790> & <1790> Aligned)
Particulate contamination is a leading cause of injectable product rejection. FTI offers:
- Visual inspection standards
- Quantification of visible particles under 10,000–15,000 lux lighting (per USP <1790> §5.4)
- Root cause evaluation of particulate origin (formulation, packaging, environment)
All testing is done in compliance with USP <790> (Visible Particulates) and linked with USP <1790> risk-based inspection approaches.
USP <1790> Compliance Testing in India
We help pharmaceutical manufacturers implement robust visual inspection programs compliant with USP <1790> by offering:
- Lifecycle-based inspection strategy consulting
- Inspector and Automatic Visual Inspection Machine Qualification India
- POD analysis and statistical reporting
- Cleanroom-calibrated Visual inspection standards
- Inspector performance monitoring tools
“Visual inspection is not merely a technique—it is a regulatory requirement that demands documented performance and ongoing control.”
– USP <1790>, Section 7.0
Why Choose FTI Incorporation?
Partnering for Compliance, Quality, and Confidence in Visual Inspection
1.
Regulatory-Driven Quality Assurance -
As a leading Knapp Kit Manufacturer, FTI Incorporation integrates USP <1790> visual inspection principles into every stage of our production and validation process. Our defect kits, calibration protocols, and cleanroom validation are meticulously documented to ensure full traceability, reproducibility, and compliance with international regulatory expectations (FDA, EMA, WHO PQ).
2.
Industry-Leading Technical Expertise -
Our multidisciplinary team includes visual inspection specialists, quality assurance auditors, and POD data analysts. With deep knowledge of manual and Automatic Visual Inspection Machine Qualification India validation, we guide our clients through inspector qualification, POD study design, and regulatory inspection readiness.
All solutions are backed by real-world validation experience and USP <1790>-driven defect classification methodology.
3.
End-to-End Visual Inspection Solutions -
From certified Ampoule Knapp Kit, vials, cartridges, and lyophilized products to inspector training, Automatic Visual Inspection Machine Qualification India, and Visual inspection standards—FTI delivers a turnkey solution. We help pharmaceutical manufacturers implement risk-based, lifecycle inspection programs in alignment with Annex 1 and USP <1790> requirements.
4.
Client-Focused & Customizable -
We understand the diverse regulatory pressures faced by pharmaceutical manufacturers. Our solutions are modular, scalable, and customizable—tailored to match your product formats, inspection environments, and validation needs. We prioritize long-term collaboration through technical consultations, requalification support, and audit readiness assistance.
FTI Incorporation is your strategic partner in achieving inspection integrity, regulatory compliance, and product safety. Whether you need an ampoule Knapp kit, PFS inspection validation kit, or USP <1790>-aligned POD qualification service, we are equipped to support every stage of your visual inspection lifecycle.
Reach out today to explore how we can support your GMP visual inspection strategy with precision, confidence, and compliance.
FAQ
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.
