Abstract
The Invivo2 / Concept / Concept-M Series Workstations have been recently remodelled, and now include a standard HEPA filter. This report details the HEPA filter testing and results for the common body of these workstations to determine air cleanliness using EN ISO 14644-1 as a reference for performance limits and test methods, as well as measurement against US FED STD 209E, and EU GMP Annex A. Using these standards, the new Workstations are determined to achieve ISO Class 4, Class 10, and EU Grade A air determined by particle count.
Introduction
Baker Ruskinn design and manufacture workstations for the anaerobic microbiology, cell biology, stem cell and regenerative medicine markets. These workstations have historically controlled temperature, humidity, Oxygen, and Carbon Dioxide concentration. As technology and science develops, our workstations will too, grow. This new upgraded model has been redesigned to meet and exceed these new expectations, one of which is to provide and maintain a clean working to avoid contamination of the end users’ cultures.
A standard measure of the cleanliness of the workstation is to measure the particulate levels that are inside the working environment to ensure that there are no potential sources of contamination during normal operation, or unwanted external sources. HEPA filters are common tools used to reduce particulate load in an airflow system like this one. Particle counters are the primary tool used for determining their effectiveness as outlined in several international standards, such as EN ISO 14644-1, US FED STD 209E, and EU GMP Annex A.