Particulate Matter Testing

What is Particulate Matter Test?

Particulate matter refers to the extraneous, mobile, undissolved particles, other than gas bubbles, unintentionally present in injections, parental infusions, ophthalmic solutions, and various medical devices. Particulate Matter testing is used to remove, count, and size particulate contaminants inherent to a product, or coming from the manufacturing process. This test is useful for detecting the amount of particulate matter inherent to a product or from the manufacturing process. Simulating- use testing is useful for determining the amount of particulate matter shedding from the use of a device. Particulate matter testing is meaningful for identifying the potential source of particles, as well as avoiding a product's potential risk to a patient.

Testing methods

Two methods used in particulate matter testing are Light Obscuration Particle Count test and Microscopic Particle Count test.

• Light Obscuration Particle Count

Light Obscuration Particle Count test is taken from the United States Pharmacopeia Method <788>, which gives criteria for the injectable solutions, uses a suitable apparatus based on the principle of light blockage which allows an automatic determination of the size of particles and the number of particles according to size. The size ranges used for USP testing are ≥10 μm and ≥25 μm. The liquid particle counter is capable of sizing and counting particles with diameters ranging from 2 μm to 100 μm.

• Microscopic Particle Count

The general procedures for Microscopic Particle Count test including Wet the inside of the filter holder fitted with the membrane filter with several milliliters of particle-free water; Transfer the total volume of a solution pool or a single unit to the filtration funnel, and apply vacuum; Place the filter in a Petri dish and allow the filter to air-dry; After the filter has been dried, place the Petri dish on the stage of the microscope, scan the entire membrane filter under the reflected light from the illuminating device, and count the number of particles. The procedure is taken from the United States Pharmacopeia Method <788>, which gives criteria for injectables solutions, the size ranges used for USP testing are ≥10 μm and ≥25μm.

STEMart offers Particulate Matter Testing Services with a broad particulate matter testing range of <0.001 μm to >3,000 μm. We can provide accurate analysis and material characterization from nanometer scale particles to bulk powders with our variety testing techniques.

If you have additional questions about Particulate Matter Testing or would like to find out more about our medical device services, please feel free to contact us.