Contaminated products pose an obvious health risk to patients. That is why pharmaceutical/ life science companies are required to manufacture in controlled environments as part of their overall contamination control program. These environments must be monitored to assure control is maintained, making it critical that the monitoring instruments and software implemented must be capable of generating reliable, timely results with demonstrable data integrity.
SOLUTIONS FOR CLEANROOM MONITORING AND CLASSIFICATION
Classifying cleanrooms to the designed level of cleanliness helps to ensure compliance, safety, and operational effectiveness. Continuously monitoring cleanrooms provides real-time information to help address potential events as they happen and provides supporting data when performing a root cause analysis.
TSI AeroTrak® Particle Counters provide accurate measurements along with easy reporting. Whether you periodically certify your clean areas, continuously monitor them, or both, a TSI AeroTrak® cleanroom particle counter can help you simplify your task, while staying in compliance and control. These products are specifically designed to meet the rigid requirements of various industries.
TSI´s Facility Monitoring Software turns critical environmental data into information. With best-in-class features, such as OPC UA Client/Server, distributed databases, and hot standby, TSI FMS Software is ready for Pharma 4.0 with unparalleled flexibility and reliability to communicate and exchange data with different IT systems and software applications. The OPC UA Client/Server functionality decreases installation costs by simplifying facility monitoring system design, offering easy and immediate access to real-time and historic data from all sensors connected to FMS.
VIABLE PARTICLE DETECTION
In Pharmaceutical, Biotech, and Medical Device cleanrooms, it is imperative that Quality Control leaders know if any airborne contaminants put products at risk - immediately. It is also important to understand what the contaminants are, and their origin. Important environmental measurements assist with keeping processes in control and with helping to find the root cause of unwanted events. TSI BioTrak® Real-Time Viable Particle Counters utilize patented fluorescence detection technology to monitor cleanrooms for viable particles and other potential contaminants.