Particulate matter can be harmful when introduced into the bloodstream. Therefore, the US Pharmacopeia places limits on the amount of sub-visible particulate matter that are allowed in both injections and ophthalmic solutions based on these risks, as described in USP<788>, USP <789>, USP <1788.2> and 〈790〉 Visible Particulates in Injections.
For the determination of particulate matter, two procedures, Method 1 (Light Obscuration Particle Count Test) and Method 2 (Microscopic Particle Count Test), are specified. As per Method 2 the filter assembly for retaining particulate matter consists of a filter holder made of glass or other suitable material, and is equipped with a vacuum source and a suitable membrane filter. The particulate matter count is determined by a filter paper analysis. The filter paper analysis is an important part of the quality control process for injectable, ophthalmic, and MDI products. This analysis helps to identify and quantify any particulate matter that may be present in the product. The filter paper analysis is done to ensure that the product is free of any unwanted particles. The filter paper analysis is done by placing the sample on a filter paper and then observing it under a microscope. The particulate matter is then counted and the total particulate matter count is determined. The particulate matter is identified and classified according to their shape and size. The results of the filter paper analysis are then compared to the acceptable limit as set by the regulatory body. Any particulate matter that exceeds the acceptable limit are unacceptable. This analysis helps to ensure that the product is free of any unwanted particles and meets the required standards.
ImageProVision offers semi-automatic software and fully automatic software called as ipvPCount and ipvAutoCount respectively. This software helps in counting Particulate Matter which is present in the parental drug. The reports are generated according to USP general chapters <788>, <789>, <790> and <1788> protocols.