FTI Incorporation: Your Trusted Partner for Quality Assurance in Visual Inspection and Testing
At FTI Incorporation, we are committed to providing high-quality solutions for the pharmaceutical and manufacturing industries. Our extensive range of products and services includes the Knapp Test Kit for AVI India, USP 1790 Compliance Testing India, and various visual inspection solutions. We ensure that your products meet the highest standards of quality and safety.
Understanding the Importance of Visual Inspection
Visual inspection is a critical process in ensuring the quality of products. It helps identify defects, contamination, and other issues that could affect the safety and efficacy of pharmaceutical products. With the right tools and guidelines, companies can maintain high standards of quality control.
Visual Inspection Guidelines India
In India, there are specific visual inspection guidelines that companies must follow. These guidelines help ensure that visual inspectors are adequately trained and equipped to identify defects and contamination. By adhering to these standards, businesses can improve their inspection processes and ensure compliance with industry regulations.
The Role of Certified Visual Inspectors India
Having certified visual inspectors India is essential for maintaining quality in production. These inspectors undergo rigorous training to understand the visual inspection process and the common defects that can occur in products. Their expertise ensures that products are thoroughly checked before they reach the market.
Knapp Test Kit for AVI India
One of our flagship products is the Knapp Test Kit for AVI India. This kit is designed for Automatic Visual Inspection (AVI) systems, providing a reliable method for testing the integrity of packaging. The Knapp Test Kit helps companies verify that their visual inspection machines are functioning correctly, ensuring that only products that meet quality standards are released.
Features of the Knapp Test Kit
- Comprehensive Testing: The Knapp Test Kit includes everything needed for thorough testing of visual inspection machines.
- User-Friendly: Designed for ease of use, the kit allows operators to perform tests without extensive training.
- Reliable Results: Our kit provides accurate results, ensuring that your inspection processes are effective.
Automatic Visual Inspection Machine Qualification India
In India, it is crucial to qualify your automatic visual inspection machine to ensure it meets industry standards. Our Automatic Visual Inspection Machine Qualification India service helps companies validate their machines, ensuring they operate efficiently and effectively. This qualification process is vital for maintaining product quality and compliance with regulations.
Particle Contamination Testing India
Another critical aspect of quality assurance is particle contamination testing India. This testing identifies any unwanted particles in products, which can compromise safety and efficacy. At FTI Incorporation, we offer comprehensive solutions for particle contamination testing, helping businesses maintain the highest standards of quality.
Visual Inspection and Defect Kit to Qualify Visual Inspector
Our Visual Inspection and Defect Kit to Qualify Visual Inspector is designed to train and evaluate inspectors. This kit includes various samples and materials that help inspectors learn to identify defects accurately. By using this kit, companies can ensure that their inspectors are well-prepared to maintain quality standards.
Benefits of the Visual Inspection and Defect Kit
- Training Tool: The kit serves as an excellent training resource for new inspectors.
- Evaluation Method: It helps companies assess the skills of their inspectors, ensuring they are qualified for the job.
- Improved Accuracy: With proper training and evaluation, inspectors can identify defects more accurately, reducing the risk of errors.
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.
Knapp Kit Producer and Manufacturer
As a leading Knapp kit producer and Knapp Kit manufacturer, we take pride in offering high-quality testing kits that meet industry standards. Our commitment to quality ensures that our kits are reliable and effective for various applications, including the Ampoule Knapp Kit, PFS Knapp Kit, Cartridge Knapp Kit, and more.
Types of Knapp Kits
- Ampoule Knapp Kit: Specifically designed for testing ampoules, ensuring they meet quality standards.
- PFS Knapp Kit: Tailored for pre-filled syringes, providing reliable testing for this essential product.
- Cartridge Knapp Kit: Ideal for cartridge-based products, ensuring their integrity and safety.
- Vial Knapp Kit: Designed for vials, this kit helps maintain the quality of liquid products.
- Lyophilized Knapp Kit: Focused on lyophilized products, ensuring they are free from defects and contamination.
How to Purchase Knapp Kits
Purchasing a Knapp kit is straightforward. At FTI Incorporation, we offer various options for Knapp kit purchase. You can easily browse our website, select the kit that meets your needs, and place an order. Our team is always available to assist you with any questions or concerns.
Visual Inspection Standards
Adhering to visual inspection standards is essential for maintaining product quality. These standards outline the procedures and criteria for conducting visual inspections effectively. By following these standards, companies can ensure that their products are safe and meet regulatory requirements.
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
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...
We offer Knapp Test Kit for AVI India engineered for
- 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
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.
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.