Real-time monitoring of cleanrooms for biological hazards

In the pharmaceutical industry, biological contamination of a cleanroom is among the most expensive possible problems. Complex measurement technology can now ensure a level of safety previously impossible. With the BioTrak from manufacturer TSI, the viability of particles in the air can be measured – in real time. Because even a single bacterium can cause enormous costs in a highly classified pharmaceutical cleanroom. In extreme cases, an entire day's production is contaminated and must be destroyed. Previously, technology could only measure the particle count in the air. But viability – whether it is dust or bacteria – could only be determined after several days of analyzing a sample. With laser-induced fluorescence technology (LIF), the BioTrak from TSI (www.tsi.com) enables the measurement of viability, with an alarm function that reports critical contamination immediately.

Unlike analysis after the production process, this real-time method allows immediate countermeasures to be taken. Previous laboratory investigations take up to four days – making timely reactions for decision-makers in the pharmaceutical industry impossible. Additionally, produced batches are initially stored in quarantine. The portable BioTrak measures the total particle count in the air, the particle concentration, and the viability – the ability of viruses, bacteria, or fungi that may be in the air. The technology developed by TSI uses ultraviolet laser light on particles. If the cells are viable, or even dead but still containing remnants of cellular metabolism, light is emitted at different wavelengths. These wavelengths are analyzed, providing immediate insights into the hazard potential. “With this technology, pharmaceutical companies can drastically increase operational safety and minimize losses just as dramatically,” says Nathalie Cholin from TSI.

The device, through particle counting with a flow rate of 28.3 L/min, meets the requirements of ISO 21501-4, as well as ISO 14698-1 for further microbiological testing of samples. Also critical for the pharmaceutical industry is the device's validation capability. Two sensitivity levels are aligned with critical process monitoring levels A/B and ISO 5/6 for cleanrooms, or levels C/D and ISO 7/8 for cleanrooms. An integrated 37 mm diameter sample collection filter collects particles for up to nine hours – a single shift, measured using fluorescence detection. This allows, with the help of standardized accompanying procedures, further microbiological analysis and specification according to ISO 14698-1. Ethernet and USB interfaces enable the use of measurement protocols according to ISO-14644-1, EU GMP Annex 1, and FS209E. This export also allows seamless integration into a monitoring system (FMS).