Particle Sizing, Distribution, Counting, Property, and Identification Analysis
Particle size and particle distribution significantly impacts drug product efficacy as well as other organic, inorganic, and metallic materials. Triclinic Labs has significant experience in both wet and dry particle size and distribution analysis, method development, contaminant identification, property determination and support of the following monographs:.
- USP <429> Laser Diffraction Measurement of Particle Size
- USP <846> Specific Surface Area
- USP <1174> Powder Flow
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We offer both cGMP and non GMP testing services. Please see below for more detail about the services we offer.
Please contact us about cGMP Particle Size Method Development, Validation, and Release testing.
Particle Size Analysis and
Particle Size Distribution -
Determine size and distribution of particles
| Application AND Technique Description | ||
|---|---|---|
In a laser diffraction particle size measurement, a laser beam passes through a dispersed
particulate sample and the angular variation in intensity of the scattered light is measured.
Large particles scatter light at small angles relative to the laser beam and small particles
scatter light at large angles. The angular scattering intensity data is then analyzed to
calculate the size of the particles that created the scattering pattern using the Mie theory
of light scattering. The particle size is reported as a volume equivalent sphere diameter.
The particle-size distribution (PSD) of a powder, or granular material, or particles dispersed
in fluid, is a list of values or a mathematical function that defines the relative amount,
typically by mass, of particles present according to size (see figure below)
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| Instrument | Model | Notes |
| Malvern |
Mastersizer 3000 v.3.70
Malvern Access Configurator v.2.20 Particle Analysis Ranges: Dry Range: 0.1 - 3500um Wet Range: 0.01 - 1400um Results from instrumental analysis includes a graphical representation of the particle size distribution as well as typical statistics such at d10, d50, d90, and d[4,3]. |
We offer cGMP method development, validation, and release testing.
Contact us for details.
cGMP Analysis and Method Development Available |
Hall Flow Rate Testing -
Powder flow rate and density
| Application AND Technique Description | ||
|---|---|---|
|
This technique determines both flow rate and apparent density. It is applicable to both
free-flowing metallic powders and other fine powders testing. The testing is performed
with a calibrated hall flowmeter funnel according to International Standards.
Used in: Powder metallurgy, metallic powders, food powders, cement powders, plastic powders, rubber powders, ceramic powders, pharmaceutical powders,foundry,casting,metalworking. |
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| Instrument Brand | Model | References |
| Hall FlowMeter | AS-300 | |
Particle Charge Analysis -
Identify handling issues due to charge
| Application AND Technique Description |
|---|
|
Powders and other materials can acquire an electrical charge on the surface of their
particles due to contact and movement against processing and handling equipment and
containers. Contact, friction, and movement of particles within the material itself
can also cause charge acquisition.
It is important to measure particle charge since this can lead to problems and unstable flow and powder behaviors. Charged materials stick to processing equipment and storage systems, can become airborne more easily, and can flow in different ways than materials with no charge. |
Density Testing -
Density is the mass of a substance with regard to the space in which it occupies. It is important to determine the density when there are changes in vendor materials or in processing.We offer the following density testing: (True, Apparent, Bulk, Tapped, Carr index)
Tapped and Bulk Density -
Explore powder flowability and settlement
| Application AND Technique Description | ||
|---|---|---|
|
The bulk density of a material is the ratio of the mass to the volume (including the inter-particulate void volume)
of an untapped powder sample. The tapped density is an increased bulk density attained after mechanically tapping a
container containing the powder sample. The tapped density is obtained by mechanically tapping a graduated measuring
cylinder or vessel containing the powder sample. This technique is particularly useful in powder flowability studies
and also in determining the amount of settlement.
The compressibility index and Hausner ratio are measures of the products ability to settle, and permit an assessment of the relative importance of inter-particulate interactions. In a free-flowing powder these interactions are less significant and the bulk and tapped densities will be closer in value. For poorly flowing materials, there are greater inter-particulate interactions and a greater difference between the bulk and tapped densities will be observed. The differences are reflected in the compressibility index and Hausner ratio. |
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| Instrument Brand | Model | References |
| Caleva | TDT 12 | WHO Reference for Bulk and Tapped Density |
Other Testing Services Available:
- Charge
- Porosity
- Release Testing
Contact us for further details or pricing.
Particle Analysis Service Levels Available:
