The size and count of particulate matter are critical factors when considering potential risk to patients.
Particulate matter testing forms part of the regulatory requirement to ensure unintended and non-therapeutic particulates in products do not exceed established limits.
DDS supports the following tests for both visible and sub-visible particles:
It is a regulatory requirement for manufacturers in the pharmaceutical and biopharmaceutical sector to be able to show a detailed understanding of their process.
Consequently, there is increasing pressure on companies to be able to determine the identity and origin of such matter rather than to merely rely on the counting of the particles.