The PCMA department has set up and launched a specialized area for particulate matter control.

To organize the work, a separate room was equipped with HEPA-filtered laminar flow hoods, laminar flow workstations, and a ventilation system. This approach ensures the comprehensive detection of particles of various sizes and maintains a high level of purity and clarity in the tested preparations, minimizing the risk of sample contamination.

To detect invisible (subvisible) particles, a GRAN-152 photometric particulate matter analyzer is used, which is located in a Class A clean zone within the department of physicochemical testing methods. Visible particles are monitored in a Class D clean zone using a SvetoChek®-FBL device designed to check solutions for particulate matter. We test the purity of injectable and infusion preparations for compliance with the Russian State Pharmacopoeia (SP RF) XV, GPM.1.4.2.0006 "Subvisible particulate matter in parenteral dosage forms" and SP RF XIV, GPM.1.4.2.0005.18 "Visible particulate matter in parenteral dosage forms and ophthalmic dosage forms."