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Visual Inspection Defect Kits, Featured Products
Knapp Kit, Manual Visual Inspection Kits, Particles, particulate Matters (Cost is Per Particle/Container)
Original price was: ₹2,600.00.₹1,300.00Current price is: ₹1,300.00.
Manual Visual inspection kits (Liquid and Lyophilized formulation with pack style of Vial, Cartridges and PFS) , Knapp kits for Manual and Automatic visual inspection machines, Particulate matters of different micron size range at very competitive price.
Catalog:
Visual Inspection Knapp Kit _ Confianca Pharmazon
Visual Inspection Knapp Kit/Defect Kit
We are the manufacturer of high standard certified Manual Visual inspection defect kits (Liquid and Lyophilized formulation with pack style of Vial, Cartridges and PFS) , Knapp kits/Defect Kits for Manual and Automatic visual inspection machines, Particulate matters of different micron size ranges from 50 micron to 5000 micron at very competitive price. Kindly go through the attached catalogue for further details.
We are also offering the below services:
- Seeding of Particles at your site + Complete Kit Preparation at Our Ahmedabad Lab
- Quality product with cost effective and timely delivery
- Audit supportive documents with certificate of particulate matter
- Free replacement of any particle or containers, it may happen during transport.
- Audit response support – Requirement basis.
- Particle/Fibers sizing with images as per USP guidance and requirements.
- Onsite and Offsite Training on Visual inspection topic.
Introduction: Visual Inspection Knapp Kit/Defect Kit
What Is a Defect Kit?
A controlled set of containers containing both good units and intentional defect samples.
Reject Composition
Typically includes 10–20% reject units to challenge inspection effectiveness.
Inspector Qualification
Used to qualify and assess manual visual inspectors.
Machine Qualification
Validates performance of automated and semi-automated inspection machines.
Advanced Inspection Systems
Supports qualification of integrity testing and X-ray inspection equipment.
Cofianca Pharmazon Providing Visual Inspection Knapp Kit/Defect Kit
Our Visual Inspection Services
At Confianca, we support pharmaceutical companies in strengthening their visual inspection processes and achieving regulatory compliance through end-to-end solutions.
Our key offerings include:
- Defect Kit Preparation & Qualification
Design, preparation, and qualification of defect test kits in line with USFDA and global regulatory expectations. - Visual Inspection Training & Certification
Comprehensive training programs and certification for visual inspectors to ensure consistency, accuracy, and compliance. - Knapp Study Management
Complete coordination and administration of Knapp studies to validate inspector performance. - Visual Inspection Program Development
Creation and implementation of robust visual inspection programs aligned with regulatory guidelines. - Vision System Commissioning & Qualification
Commissioning and qualification of automated and semi-automated vision inspection systems for reliable defect detection. - Troubleshooting & Continuous Improvement
Root cause analysis, process optimization, and ongoing improvement of inspection systems and practices. - Audit Readiness Support
Preparing organizations for regulatory audits by strengthening documentation, processes, and inspection controls.
How We Prepare the Defect Kits:-
1.0 Process description:Generation of Particulate Defects:
- Each particle & Fiber defect shall be created by highly trained and qualified technicians by using real source of Primary packaging material (PPM), Material used for machine parts/product contact part, Filter and garments used in Aseptic area.
- Each particle is generated using the sieves and filtration method analysis. Each particle shall be washed and dried before using.
- Each particle shall be measured through a (2 dimensional) high resolution & high-density digital microscope.
- After this, these particles are seeded inside the vials/containers in controlled area condition (Pressurised area through Laminar/Uniform air flow ISO 5 air supply). These containers with seeded know size particles are visually inspected against the black and white background visual inspection booth by trained and qualified inspectors.
- During process, it is taken care not to have other or multiple defects other than said defect.
- It is recommended to have Terminal sterilization of containers for longevity of kits at your end.
- In case of supply of only particles, Each particle shall be packed inside the MCT tubes.
- In case of supply of only particles, Technical team of Confianca Pharma-zon shall guide to your team to seed the particle inside the container or any other type of queries.
- Each container shall affix readable sticker having unique number matching with main report.
- Each container shall be wrapped separately with bubble sheet to avoid transportation scratches.
1.1 Generation of Cosmetic defect:
- Cosmetic defects are falling under Critical/Major/Minor category based on the impact on patient and product.
- As per requirement, each cosmetic defect shall be prepared with high precaution by trained technical staff.
- Upon preparation of cosmetic defects, each unit shall be verified with high resolution magnification followed by high density digital microscope.
- During process, it is taken care not to have other or multiple defects other than said defect.
- Each cosmetic defect containers shall be verified by trained Visual Inspector for determination of Probability of inspection (POD). More than 70% POD are considered as defect container.
- Each container shall affix readable sticker having unique number matching with main report.
- Each container shall be wrapped separately with bubble sheet to avoid transportation scratches.
- Shall provide Main Certificate containing all types defects with their size measurement with actual microscopic sizes, images report (containing images of all particulate defects with sizes measured during preparation), ISO 5 certificate (used to seed the particles), Microscope calibration certificate, Microscope calibration master certificate. These all certificate complies with USFDA, EU and other regulators.
1.2 Good Containers:
- Each good container shall be 100% free from particulate matter as well any cosmetic defects.
- Each container has to clean & dry thoroughly by using appropriate method before processing to next step.
- Each container has to be verified in 3 steps for elimination of any type of defect. i.e.: Physical verification under high light intensity, by high resolution magnification method & by high density digital microscope.
- Each good container shall be verified by trained Visual Inspector for determination of Probability of inspection (POD).
- Each container shall affix readable sticker having unique number matching with main report.
- Each container shall be wrapped separately with bubble sheet to avoid transportation scratches.
- Shall provide good containers certificate in main report which shall comply with USFDA, EU and other regulators.
What you will get :-
2.0 What you will get:
- Particulate Defects seeded in containers provided as per Matrix suggested.
- Cosmetic Defects as suggested in Matrix.
- Supply of certified particles as per sizes and MOC mentioned in Main Report
- Images of Particles/Fibers
- Certificate of NABL certified Microscope
- Certificate of Micro meter (Master instrument used for Microscope calibration)
- ISO-5 Certificate (LAF used for activity)
- Probability of detection (POD) evaluation sheet (Each container inspection by 2 Inspectors).
Why Visual Inspection Knapp Kit required?
- Visual inspection plays a vital role in ensuring the safety, quality, and compliance of parenteral pharmaceutical products.
- All parenteral products are required to undergo 100% in-process visual inspection to identify visible particles and physical defects that may compromise patient safety.
- As per USFDA expectations, visual inspection focuses on three fundamental objectives
- Visual inspection serves as the final quality checkpoint before a product is released to patients.
How Confianca Pharmazon is better than other Global Suppliers
3.0 How Confianca Pharmazon is better than other Global Suppliers:
- Longer self-Life.
- Technical support and special kit handling training at Pharma-zon lab located at Ahmedabad.
- Particle/Fibers sizing with certificates as per USP guidance and requirements.
- Quality product with cost effective and timely deliverable
- Having 25+ year of experience in Pharma/Biopharma Industry which can enable client’s to get support for audits and other queries regarding visual inspection program
- Technical guidance for Customization – before and after supply
- Beyond a Visual inspection kit – We help build ecosystem of visual inspection qualification ecosystem
- Lastly Cost leadership – we are highly competitive against other international supplier for better international quality
Certification of Conformance
4.0 Certification of Conformance:
- Main Certificate for Particulate Particle & Fiber
- Image Raw Data (Certified Particle Size & Fiber Size)
- Calibration Certificates of Microscope (NABL approved)
- Master Certificate of Microscope
- ISO-5 Certificate (LAF used for activity)
- Confianca – ISO-9001:2015 Certificate
Sample Certificates
Particulate defects for Knapp Kits/Defect Kits
Description: Black Particle, White Particle, Glass Particle, SS Particle, Rubber Stopper/Elastomeric Particle, Red Particle, Gasket Particle, Yellow Particle, Black Fiber, White Fiber, Green Fiber, Blue Fiber
Cosmetic defects for Knapp Kits
Description: Damage Seal, Chips, Check on Vial, Missing Flip Off, Without Seal, Scratches, Air Bubble, Vial Molding, Broken Vial, Deshaped Vial, High & Low Volume, External Spot
Microscopic Images for defects
Description: Microscopic of Black Particle, White Particle, Glass Particle, SS Particle, Rubber Stopper/Elastomeric Particle, Red Particle, Gasket Particle, Yellow Particle, Black Fiber, White Fiber, Green Fiber, Blue Fiber
Formulations done so far
Description: Emulsion, Clear Liquid, Specialized PFS, Cartridge, CPZ Box 1, IV Bags, Oncology Product, CPZ Box 2, Amber and Clear Ampoules, Bag in Bag (BIB), Suspension, Lyo Vial
Particle Chractization SEM Images
Description: PP Container, Hypalon Gloves, TC Clamp, Teflon Bush, Product Filter, Gasket (Manual Valve), Gasket of Pressure Vessel, 2ml Syringe, Pharma Pure Tubing, Measuring Cylinder, Ceramic, Plunger Rod.
Microscopic analysis for defects
Description: Black Particle, Black Fiber, SS Particle, White Fiber, White Particle
Satisfied Customers till date …..
Resources :-
Frequently Asked Questions
1. What is a Visual Inspection Knapp Kit or Defect Kit?
A Visual Inspection Defect Kit is a controlled collection of containers containing known particulate defects, physical defects and verified good units. Pharmaceutical manufacturers use these samples to train inspectors, assess inspection performance and support inspection-system qualification. Kits intended for Knapp studies are evaluated for detection behaviour under defined inspection conditions.
2. What are Knapp Kits used for in pharmaceutical manufacturing?
Knapp Kits support visual inspector training and qualification, inspection-method evaluation and performance assessments of manual, semi-automated and automated inspection systems. They provide representative challenge samples that help teams evaluate how consistently defects are detected.
3. Which container types can Confianca Pharmazon prepare defect kits for?
We prepare customised defect kits for vials, ampoules, prefilled syringes (PFS), cartridges and IV bags. Preparation requirements are reviewed according to the container material, size, closure system and formulation.
4. Can you prepare kits for different formulations?
Yes. Our experience includes clear liquids, lyophilised products, suspensions, emulsions and specialised prefilled syringe presentations. The preparation approach is assessed for each product because formulation characteristics can affect particle visibility and sample stability.
5. What types of particulate defects are available?
Available options include glass, stainless steel, rubber or elastomeric particles, gasket particles, coloured particles and fibres. Particle materials, colours, sizes and quantities are selected according to the agreed defect matrix and their relevance to your manufacturing process.
6. What particle sizes can you supply?
Our offering includes particles in the range of 50–5,000 µm, subject to material and preparation feasibility. The required sizes are agreed before preparation, and measured dimensions are documented. Particle size alone does not determine visibility; formulation, contrast, container characteristics and inspection conditions also influence detection.
7. Which physical and cosmetic defects can be included?
Examples include damaged seals, missing flip-off caps, missing seals, cracks, chips, scratches, malformed containers, external spots and high or low fill volumes. Defect classification as critical, major or minor should follow your approved risk assessment and defect catalogue.
8. Can the defect kit be customised to our approved matrix?
Yes. We can prepare kits based on your specified container presentation, defect types, particle materials, target sizes and quantities of defective and good units. Our team reviews the matrix with you to confirm feasibility and documentation requirements before preparation.
9. Can you use containers or filled units supplied by us?
Yes. Client-supplied containers or filled units can be assessed for kit preparation. Using a representative product presentation helps align the challenge samples with your inspection process. Sample quantities, handling conditions and preparation responsibilities are agreed before work begins.
10. How are particles measured and documented?
Particles and fibres are measured using digital microscopy before seeding. Microscopic images and measured dimensions are linked to the relevant sample records, supporting traceability between the prepared defect and the supplied documentation.
11. How are individual kit samples identified?
Each container is assigned a unique identification number corresponding to the main report. This allows users to connect the sample with its documented defect description, particle information and applicable evaluation records.
12. What documentation is supplied with the kit?
Depending on the agreed scope, documentation includes the main kit certificate or report, defect matrix, particle and fibre measurement images, relevant calibration certificates, the applicable ISO 5 work-area certificate and probability-of-detection evaluation sheets.
13. What is probability of detection, and why is it relevant?
Probability of detection (POD) describes how frequently a sample is detected or rejected during repeated inspections under defined conditions. It helps characterise the challenge presented by individual samples and supports interpretation of inspection performance. Evaluation methods and acceptance criteria should be defined in the study protocol.
14. Do you provide both defective and good samples?
Yes. Kits can include particulate defects, physical defects and units verified as good under the defined inspection procedure. The quantities and distribution are agreed in the kit matrix to suit the intended training or qualification exercise.
15. Can you supply particles separately or perform seeding at our site?
Yes. We offer individual particles and fibres for client-side preparation, onsite particle seeding and complete kit preparation at our Ahmedabad laboratory. The appropriate service is agreed based on your facilities, product-handling requirements and project scope.
16. Do you provide visual inspection training and technical support?
Yes. Confianca Pharmazon offers onsite and offsite visual inspection training, kit-handling guidance and support for Knapp studies and inspection-program development. Documentation and audit-response support can also be discussed according to your requirements.
17. How should the defect kit be stored and maintained?
Follow the handling and storage instructions supplied for your kit. Protect samples from damage and conditions that could alter the formulation, container or seeded defect. Periodically check sample condition and identification, and reassess any unit showing changes before further use.
18. What information is required to request a quotation?
Please share the container type and size, formulation, inspection method, required defect types, particle materials and sizes, quantity of each defect, number of good units and documentation requirements. Include your target delivery date and whether you will supply the containers or filled units.
Contact Confianca Pharmazon to discuss a customised Visual Inspection Knapp Kit/Defect Kit for your facility.
Phone: +91 9173319482
Email: gaurav@confiancapharmazon.com
Location: Ahmedabad, Gujarat, India
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Waseem Khatib –
Nice product