Pharmaceutical and biotechnology clean rooms are designed to produce, package and transport medicines and health products. Environmental monitoring (EM) programs are put in place to ensure product quality, and patient safety. These EM programs typically include measuring or monitoring airborne non-viable and viable particles, as well as other environmental parameters.
For non-viable, or airborne particles, these clean rooms must comply with regulatory guidelines. These standards define particle count limits and methodologies for particle cleanliness classification and monitoring, directly referencing current ISO 14644-1 and -2 particle air cleanliness standards.
Viable particles are particles that include microbiological constituents that could contaminate the product. These are typically monitored using an air sampling technique. Manufactured pharmaceutical product must wait, typically 3-5 days, for results.
Recent technological advancements, based on optical analysis of individual airborne particles, provide a new method of detecting viable particles, in Real-Time. This technique is referred to Real-Time Viable Particle Counting.
TSI’s BioTrak Real-Time Viable Particle Counter, provide Quality Assurance professionals with additional, valuable information to find root causes of viable and non-viable particle excursions.
The fundamental technology found in these products is Laser Induced Fluorescence (LIF). The basis of viability detection using LIF is the intrinsic fluorescence of microbiological constituents. In simple terms, when laser light is directed at particles, the particles that have certain microbiological properties will "glow". The wavelength and intensity of this "glowing" can be detected and categorized, to determine the viability of the particle.
About TSI Incorporated
TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, health and safety, indoor air quality, fluid dynamics and biohazard detection.