The Importance of Knapp Kits

Knapp kits are essential tools in pharmaceutical quality control, enabling manufacturers to ensure packaging integrity, patient safety, and compliance with international regulations.
As a leading Knapp kit producer, FTI Incorporation offers validated kits that meet NIST, ISO, and GMP standards. Our range includes the Ampoule Knapp Kit, PFS Knapp Kit, and Cartridge Knapp Kit, ensuring versatile solutions for all inspection needs.

By Choosing FTI, You Gain:

• Reliable and traceable inspection results
• Faster turnaround for quality assurance processes
• Reduced risk of contamination or defect release
• Compliance with global regulatory authority expectations

When you choose FTI as your Knapp Kit Manufacturer, you’re assured of excellence, compliance, and efficiency at every stage of inspection.

Knapp Kits and USP <1790> Compliance<1790>

Knapp kits play a vital role in supporting compliance with USP <1790> – Visual Inspection of Injectable Products, which defines best practices for detecting defects in injectable medicines.
At FTI Incorporation, our kits are designed in strict accordance with USP <1790>, ensuring manufacturers meet risk-based, lifecycle-driven inspection requirements. Whether you are using an Ampoule Knapp Kit or a Vial Knapp Kit, our products guarantee full alignment with USP guidelines.

USP <1790> Highlights:

• Lifecycle Approach –Kits are used across development, qualification, and routine inspection phases.
• Defect Library Standardization –Pre-qualified kits provide consistent defect references for training and qualification.
• Inspector Qualification & Requalification –Supports training, acuity checks, and periodic requalification to minimize human error.
• Control of Subjectivity –Standardized defect kits reduce variability and strengthen data integrity.
• Risk-Based Methodology –Kits support threshold studies, POD evaluations, and detection capability assessments.

Benefits of Integration:

• Establish a robust defect reference set compliant with USP <1790>
• Improve consistency in visual inspection standards
• Support inspector qualification, requalification, and training workflows
• Reduce regulatory risk and audit observations

Manufacturing Excellence

All FTI Knapp kits are produced under ISO Class 5 (Class 100) cleanroom conditions and come with complete traceable documentation, including:

• Microscopic defect images
• Size and defect classification sheets
• Validation and calibration certificates
• Expiry information (3 years)
• Training and usage documentation

Each Knapp kit purchase is backed by full traceability, ensuring that clients receive the highest level of quality assurance.

Knapp Kits for Manual and Automated Visual Inspection

FTI Incorporation offers the Knapp Test Kit for AVI India, specifically designed for both Automatic Visual Inspection (AVI) Machine Qualification and Manual Inspector Training and Qualification.
Each Knapp Test Kit for AVI India contains NIST-traceable certified defect containers, covering critical and major defects such as fibers, particles, cracks, and cosmetic damages.

These are used for:

• Initial inspector qualification and requalification
• POD (Probability of Detection) studies
• AVI system sensitivity verification
• Inspector qualification per USP <1790> requirements

All kits are calibrated under ISO Class 5 cleanroom conditions for accuracy and reproducibility. Our Knapp kit producer expertise ensures that every Knapp Test Kit for AVI India meets global and national inspection standards.

Inspector Qualification Programs

Our qualification programs are built around USP <1790> standards and include:

• Training on intrinsic, extrinsic, and inherent defect types
• Familiarization with lighting and ergonomic factors (§5.3)
• Benchmarking with Knapp kits to establish detection thresholds
• Meeting required detection probabilities (≥80%) for inspector qualification

Whether you are training for vial inspection or ampoule qualification, our Knapp Kit Manufacturer ensures that every PFS Knapp Kit and Cartridge Knapp Kit supports optimal inspector performance.

AVI System Qualification and Validation

FTI Incorporation supports AVI machine qualification and validation through:

• 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 solutions ensure reliable defect classification and compliance with regulatory expectations. As an established Knapp kit producer, we provide full support for Knapp Test Kit for AVI India applications.

Particulate Contamination Testing

Particulate contamination is one of the leading causes 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>)
• Root cause analysis for particulate origin (formulation, packaging, or environmental)

All testing is conducted in compliance with USP <790> (Visible Particulates) and aligned with USP <1790> inspection practices. We ensure that Ampoule Knapp Kit, Vial Knapp Kit, and Lyophilized Knapp Kit users meet the highest particulate detection standards.

Why Choose FTI Incorporation?

Partnering for Compliance, Quality, and Confidence in Visual Inspection

• Regulatory-Driven Quality Assurance- Every Knapp kit purchase is backed by full validation and traceability. Each kit—whether it’s a PFS Knapp Kit or Lyophilized Knapp Kit—is designed in accordance with USP <1790> to ensure compliance with FDA, EMA, and WHO PQ requirements.
• Industry-Leading Technical Expertise- Our team includes specialists in visual inspection, quality auditing, and POD data analysis. We support clients with inspector qualification, POD studies, AVI validation, and regulatory inspection readiness using trusted solutions like Knapp Test Kit for AVI India.
• End-to-End Visual Inspection Solutions- From Ampoule Knapp Kit and Vial Knapp Kit to Cartridge Knapp Kit and Lyophilized Knapp Kit, FTI delivers a complete suite of solutions for lifecycle-driven inspection programs as a global Knapp kit producer.
• Client-Focused & Customizable- Our solutions are modular and tailored to fit diverse product formats, inspection environments, and compliance needs. We provide long-term technical support, requalification services, and audit readiness assistance.

At FTI Incorporation, we serve as your strategic partner for achieving inspection integrity, regulatory compliance, and patient safety. Whether you need an Ampoule Knapp Kit, PFS Knapp Kit, or Knapp kit purchase for USP <1790>-aligned qualification, our expertise supports every stage of your visual inspection lifecycle.