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Particulate Matter Testing Required for Injectable Solutions

By Ryan D. Lunceford, Study Director, Particulate Matter Testing, B.S., ASQ

Particulate Matter Testing is required on all pharmaceutical products that come in contact with human blood or tissue. The standard is USP 788 for blood and tissue and USP 789 for contact with the human eye.

Particulate matter refers to small particles found in pharmaceuticals or vaccines injected into the human body. The standards don’t provide frequency of testing or environmental monitoring, but it is good practice to have both to ensure a clean environment during the manufacturing process since if you are high in particulate counts, you’re probably high in other areas.

Manufacturers need to determine their sampling plan so they are regularly sending in samples for particulate matter testing as well as for cytotoxicity and TOC.

Tests are conducted on liquid samples only – no air or solid materials. There are basically two tests, light obscuration, which uses light blockage to determine the size and count of particulate matter in the solution; and microscopic assay, which is a measurement of un-dissolvable particles or substances present in the solution – usually plastics, metals or dust. Ultimately for manufacturers, the objective is to keep these particles out of the product during manufacturing.

Particulate Matter Testing is particularly important for injectable solutions. The test determines whether your manufacturing processes are accurate, sample containers are cleaned properly and whether the manufacturer or sub-contractor are implementing sound process practices.

In many cases if not most cases, a particulate problem is not due to the solution, but the container. The product manufacturer needs to ensure all vendors are providing clean containers to eliminate exposure to particulates.

Nelson Labs suggests conducting Particulate Matter Testing on a quarterly basis.