ISPE SMEPAC
Minimizing production delays due to Factory and Site Acceptance Tests of containment performance is a persistent challenge. At Nanozen Industries, we have made this our number one priority without compromising testing accuracy or safety! We listen carefully to our customers’ concerns in supporting pharmaceutical sites across the globe during these challenging times.
Nanozen’s DustCount is a validated, real-time API sampler that can be calibrated to specific Active Pharmaceutical Ingredients. It also features an internal 25 mm sampling filter for further laboratory analysis. The DustCount excels in situations such as short-term exposure monitoring, rapid assessment of control changes, and as an efficient tool to develop, qualify and select best practices.
Real-world Example
The graph below shows an Occupational Exposure Band (OEB) 5 sampling to verify containment. In this situation, the Occupational Exposure Limit (OEL) of the Active Pharmaceutical Ingredient (API) was 0.1 µg/m3. Nanozen’s DustCount 9000 was pre-calibrated to the API to correct for density, optical properties and aerosolization of the powder. Particle size distribution (PSD) was simultaneously measured in real-time during sampling. Site engineers were immediately alerted to the spike and fixed the containment issues with only minor production delays.
Designed for Pharma
Now is a great time to improve your company’s productivity, plus enhance workplace protection! Find out how Nanozen’s advanced, cost-effective technology can contribute to your success.