Determination of Particulate Matter in Injectable Solutions
The BASi Pharmaceutical Analysis department has now completed the validation of instrumentation to conduct testing for particulate matter in injections. Particulate matter in injections and parenteral infusions consists of mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions. Particles present in these solutions can lead to delayed filings and recalls.
This testing monitors the number of particles >10mm and >25mm and is conducted according to USP general chapter 788, consisting of two methods: Light Obscuration and Microscopic. Both methods are conducted in a Laminar Flow hood in order to limit contamination from particulates in the lab environment.
The light obscuration particle count test employs the Accusizer 780/SIS Particle Sizer. Samples are drawn through the optical cell of the instrument and as particles pass through the cell they obscure the light passing through the cell, with the angle of the obscuration varying based upon particle size. The instrument gives a distribution of the number of particles at various sizes. The USP recommends that the light obscuration method is used if possible. This instrument is going into service May 2010.
At times, the light obscuration method cannot be used (samples with reduced clarity or increased viscosity), thus the microscopic method is used. Using an Olympus BX51 TRF Microscope, samples are filtered onto a gridded membrane, and the particles ? 10mm and ? 25mm are counted manually. This instrument has been in service since January 2010.
Having both of these instruments in-house allow us to quickly respond to our sponsors’ needs versus waiting for sub-contractors to respond.
If you have any questions about Particulate Matter Determinations, please contact Adam Myers for more information.
|
