| Defect Type |
Glass, metal, fibers, black specks, white specks, hair, rubber particles, white plastic, colored specks, clumps, sub-visible particles, fill volume variation, glass crack, aluminum seal defect, and other customized defects. |
| Partical Size |
50μm-2000μm |
| Qty |
1-3、5-10、≥10 |
| Volume |
1mL、2mL、5mL、20mL |
| Liquid Carrier |
Water, Liquid of drugs |
| Packaging Type |
Ampoules, vials, cartridges, PFS, and others |
Particle Size and Material Selection
Particle size is an important consideration when preparing visible particulate samples for pharmaceutical inspection. Different particle materials and sizes produce different visual characteristics, including contrast, shape, color and movement in liquid.
Zholion offers particle sizes ranging from 50μm to 2000μm, with different materials available according to inspection requirements.
Liquid Carrier Customization
Visible particulate samples can be prepared using different liquid carriers to accommodate pharmaceutical product requirements.
Available options include:
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Water
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Liquid drug formulations
The carrier can be selected according to the intended inspection application and sample requirements.
Pharmaceutical Container Options
Different pharmaceutical containers have different dimensions, materials and inspection characteristics. Zholion supports customized sample configurations for:
Container selection can be coordinated with particle type, liquid volume and inspection requirements.
Defect Classification in Pharmaceutical Visual Inspection
Pharmaceutical inspection defects are generally classified into three categories according to their potential impact on patient safety, product quality and container integrity.
Critical Defects
Defects that may pose a serious risk to patient safety, compromise product sterility or violate applicable regulatory requirements. These defects require immediate attention and rejection according to established quality procedures.
Major Defects
Defects that significantly affect product integrity, quality or intended performance. They may compromise container closure integrity or affect the suitability of the pharmaceutical product.
Minor Defects
Defects that primarily affect product appearance or general quality but do not directly compromise product functionality, safety or integrity under the applicable acceptance criteria.
Visible Particulate Inspection Methods
Visible particulates are insoluble matter that can be observed by the unaided eye under specified inspection conditions. In pharmaceutical inspection, particles with a size or length typically greater than 50 μm are commonly considered visible particulates.
Two main approaches are used for particulate inspection:
1. Visual Inspection Method
Visual inspection is commonly used to identify visible particles and physical defects in pharmaceutical containers. Samples are examined under specified lighting and inspection conditions to identify foreign matter such as glass fragments, metal particles, fibers, rubber particles and other visible contaminants.
Customized visible particulate samples can help pharmaceutical manufacturers establish defect libraries, evaluate inspection procedures and train inspection personnel.
2. Light Scattering Method
Light scattering is an alternative analytical approach for detecting particulate matter in liquid samples, particularly when conventional visual inspection is unsuitable, such as with deeply colored liquids or certain container configurations.
Different particle sizes and standard particle solutions can be used in equipment calibration and method evaluation, depending on the instrument and applicable testing procedure.
Visual Inspection Acceptance Considerations
During pharmaceutical visual inspection, attention is commonly given to the following particulate characteristics:
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Metal particles and glass fragments
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Fibers and elongated foreign matter
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Particle agglomerates
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Visible particulate sediment
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Numerous particles or precipitates
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Proteinaceous flocculent matter
These characteristics can be incorporated into pharmaceutical defect libraries and inspection training programs. Acceptance criteria should follow the applicable pharmacopoeial requirements and product-specific inspection procedures.
Why Choose Zholion for Customized Visible Particulates?
1. Multiple Defect Materials and Types
We provide customized particulate samples covering glass, metal, fibers, rubber, plastic, black specks, white specks and other defect types. Additional container defects can also be prepared according to customer requirements.
2. Flexible Particle Size and Quantity
Particle sizes range from 50μm to 2000μm. Customers can select different quantities and sample volumes according to their inspection and validation needs.
3. Multiple Pharmaceutical Packaging Formats
We support sample preparation in ampoules, vials, cartridges, prefilled syringes and other pharmaceutical containers to accommodate different inspection applications.
4. Customized Liquid Carriers
Water and liquid drug formulations are available as carrier options, allowing samples to be configured according to different product and inspection requirements.
5. Experience with Pharmaceutical Industry Requirements
Zholion has experience serving pharmaceutical companies, including Apptech and Hengrui Pharma. Our product and customization options are developed around practical pharmaceutical inspection and quality control requirements.
6. International Market Experience
Our pharmaceutical testing solutions are developed with reference to major international regulatory and industry frameworks, including FDA, EMA, WHO, PIC/S and NMPA-related requirements.
Why visible particulates are important?
Regulatory agencies worldwide explicitly require the use of visible particulates.
USP 1790
7.5 These qualified defects standard units are then assembled into test sets, which may be used to specifically challenge the particle detection technique of human inspectors, used as part of a defect test set (including container-closure defects) for human qualification or for comparison during automated equipment qualification and validation. When possible, the test set should be prepared with duplicate product units per particle type and size to ensure that backup units are available in the event that a standard container is broken or the particle is trapped or lost within the container.
ECA
TS1 What are the differences between qualification, particle (Knapp test) and function test set?
The function test set serves for a sort of system suitability test, i.e. this test is used to test before and after each batch whether the cameras are functioning correctly. Usually, no challenging samples are used for this, but rather unities with particles having a detection rate of 100% such as particles with a size of 1000 µm, vials with missing stoppers.
Qualification test set: the qualification test set consists of product specific containers containing the product and having all known "static" defects (scratches, wrong flip-off, missing stopper,...). Usually, about 10-20% of the containers of the set have a defect. New failures or defects are added to the qualification test set.
Particle test set (Knapp-Test): Sets that contain only particles. These are particles having the size from 50µm to 1000µm and consisting of different materials (plastic, the material stoppers are made of, glass, metal). Hence, they are "non-static", i.e. the defect is in the container or in the drug solution. Particle test sets are part of the qualification test set at the same time.
TS2 Should all these test sets be prepared artificially? Should this be done, for instance, by an external laboratory with defined failures?
We prepare the static defects in-house and a part of the non-static defects (particle defects) are produced externally. But it is also possible to have everything produced externally. But the static defects should be the same that are generated in the worst case by your production machines. Therefore, I advise to make these in-house and get the release from QA. In this way you would have representative bad samples from your process. In the best case you take bad samples from your process but it is not possible to do this for all samples.
EU GMP
8.30 A defect library should be generated and maintained which captures all known classes of defects. The defect library should be used for the training of production and quality assurance personnel. Critical defects should not be identified during any subsequent sampling and inspection of acceptable containers.
8.31 The qualification should be undertaken using appropriate samples from the manufacturer's defect library sets.
8.32 Where automated methods of inspection are used, the process should be validated to detect known defects (which may impact product quality or safety) and be equal to, or better than, manual inspection methods. The performance of the equipment should be challenged using representative defects prior to start up and at regular intervals throughout the batch.
Chinese Pharmacopoeia 2025
Visible particulates are defined as insoluble matter that can be observed by the unaided eye under specified conditions, with particle size or length typically greater than 50 μm.
Two primary methods are available for the inspection of visible particulates: the visual inspection method and the light scattering method. The visual inspection method is generally the most commonly used approach. For products for which the visual inspection method is not suitable—such as those packaged in dark transparent containers or those with deeply colored liquids (generally darker than Standard Color Solution No. 7)—the light scattering method may be employed as an alternative.
Chinese GMP Guidelines 2023
Manufacturers shall use risk assessment tools to identify potential defect types for the product, taking into account product characteristics, manufacturing processes, primary packaging materials, and historical defect data. Defect types shall be classified into severity levels-typically critical, major, and minor-based primarily on the impact on patient safety. Probability of Detection (PoD) criteria shall be rationally established for each defect type.
Defect samples shall be prepared for use in manual inspection qualification or for comparison with alternative (automated) methods. To ensure that the prepared defective samples are representative, they may be obtained from the following two sources:
- Defect samples collected from actual manufacturing processes shall be visually inspected by multiple qualified light inspection personnel, with each unit inspected 30 to 50 times in total. The detection rate (Probability of Detection) shall be calculated, and defect samples shall be classified based on the resulting detection rates.
- Defects shall be prepared in the laboratory using materials that correspond to potential contamination sources, with defect sizes that are quantifiable.
Request Customized Visible Particulate Samples
Looking for customized visible particulates for pharmaceutical visual inspection?
Zholion provides flexible solutions for different particulate materials, particle sizes, quantities, liquid carriers and pharmaceutical packaging formats. Whether you need samples for defect library development, inspection equipment validation, Knapp testing or operator training, our team can help match your requirements.
Contact Zholion today to discuss your customized visible particulate sample requirements.
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Particle Materials & Sizes
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Liquid Carriers & Sample Volumes
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Ampoules, Vials, Cartridges & PFS
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Customized Defect Types & Quantities
Send Us Your Requirements for a Customized Quote.
