Particulate Matter

Particulate matter consists of particles that will not dissolve in solution (other than gas bubble) and that are unintentionally present on your products. This test includes procedures for removing, counting, and sizing particulate contaminants in injections, parental infusions, ophthalmic solutions and various medical devices.

The purpose of the particulates testing is to determine the quantity and size of particles on the device or in the solution. This is useful for:

Determining the amount of particulate matter inherent to a product.

Detecting the amount of particulate coming from the manufacturing process.

Demonstrate the amount of particulate matter shedding from the use of a device by simulated use.

Applied standard: 

  • USP<788> Particulate Matter in Injections – Light Obscuration
  • USP<789> Particulate Matter in Ophtalmic Solution – Obscuration Test

The Light Obscuration Test is based on the principle of light obscuration, this test allows for automatic determination of the size and number of particles according to their size. The test is performed in a biological safety cabinet ISO class 5, under conditions that limit foreign particulate matter.

Particle sizes: 

The compendial requirement is to enumerate particles at ≥10 μm and ≥25 μm, although particles in the range of ≥3 μm – 100 μm can also be enumerated.

Instrumentation:

HIAC 9703+ Liquid Particle Counting System.

Device extraction step

Recovery Validation study on request

Testing – Light Obscuration Process

Particle sizes: The compendial requirement is to enumerate particles at ≥10 μm and ≥25 μm, although particles in the range of ≥3 μm – 100 μm can also be enumerated.

Results

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