Reliable Environmental Monitoring Systems by Design

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1 Reliable Environmental Monitoring Systems by Design Written by Simon Tebb, TSI - Contamination Control Sales Manager Europe, Middle East & Africa Environmental Monitoring Systems (EMS) In Cleanrooms, data measurement and collection should be a tool, not a chore. From comprehensive reporting to reliable, redundant operation, the EMS must provide the confidence you need to monitor a process, and track down a root cause. Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations and guidance such as EU GMP Annex 1:2008 (Annex 1) and FDA Guidance on Aseptic Processing An independent monitoring system is used to monitor critical processes and demonstrate that they are in control. Commonly used acronyms include FMS, IMS (Independent Monitoring System) or EMS (Environmental Monitoring System). Most end users need to show regulatory authorities that their facility is in control. Semiconductor facilities want to reduce waste and improve yields. Environmental parameters monitored can include, but are not limited to: airborne particles airborne viable particles differential pressure temperature relative humidity air velocity Sensors are located in critical locations throughout a facility. Particle monitoring locations are chosen based on detecting contamination that could potentially get into the product or process and cause harm. The manufacture of sterile products has special requirements to minimize the risk of particle and microbiological contamination. Whether manufacturing pharmaceutical drugs or medical devices, these are ultimately intended for use with ill patients. Patient safety is of paramount importance. Life science professionals are required to demonstrate that critical product manufacturing environments are kept within specified control limits. The recent update of ISO :2015 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration require all environmental parameters such a differential pressure, air velocity, relative humidity and temperature to be monitored. These parameters influence airborne particulate cleanliness, cleanroom performance and ultimately patient safety. The end user needs a robust EMS that immediately indicates a loss of process control. Warning end users of excursions via SMS text alerts, and alarm beacons in real-time. Distributing

2 the core functions of the EMS over the network with redundancy features like high level SQL databases and fail over servers are key features of a robust monitoring system. Monitoring software, like TSI s FMS, collects and stores data from these sensors every minute, 24 hours a day, and 7 days a week. This critical data is made available in real-time to the end user. A computer display and hardware alarm outputs enable an immediate response to process-critical events and excursions. Archived data is presented as historical reports for trending analysis. Typical environments monitored include: Pharmaceutical cleanrooms Blood banks In Vitro Fertilization (IVF) labs Hospital pharmacies or compounding facilities Aerospace cleanrooms Semiconductor cleanrooms Data Centers Robust Monitoring System Design The main purpose of a monitoring system is to collect data from many sensors distributed at critical locations throughout a manufacturing process, and are defined based on the principles of quality risk management QRM ICH Q9. To this end, it is critical that a monitoring system operates in a reliable and stable manner. Uninterrupted data collection must be the number one priority in any Monitoring System design philosophy. There are three main programs. The Monitor the engine of the monitoring system, collecting data and sending out alarms The Client the user interface with the system The SQL Database where all of the data is stored The only user interface a system operator uses on a regular basis is the Client. The other applications run in the background. , SMS text outputs Sensor Control Relay alarm outputs

3 Figure 1 Facility Monitoring System Overview This means that a whole system can run on just one computer, however, it is also possible for each program to run on a different computer. Here are some system design examples: 1. Simple System This type of system design is commonly used for small to medium sized monitoring systems; hospital pharmacies for example. The end user s Network is not used in this case. The simplest monitoring system implementation is to have TSI s FMS Monitor, Client, and SQL database reside on a single computer. Figure 2: Simple system schematic. The schematic shows an additional computer with a Client installed to allow the Monitor to be accessed at a second location in the facility. Other key features are: There is only one network; all of the system sensors are connected to this network. All sensors are communicating to the Monitor program via Ethernet. The Client, Monitor, and SQL database are installed together on a single FMS Monitoring computer. The FMS monitoring computer is not connected to the Corporate network. Additional Clients may be installed

4 Each Remote Particle Counter has an internal data buffer. If connection is lost, the particle counter will continue to collect data until connection is restored Poor selection of a computer can lead to poor system performance and reliability issues. The network cabling and computer network configurations are also very important. 2. Simple Distributed System This topology is commonly used in medium sized pharmaceutical or life science facilities. This design utilizes the FMS Buddy automatic hot standby in the event of a monitoring computer failure. If the main Monitor Computer were to fail, the watchdog Buddy Computer will automatically take over, preventing any loss of monitoring data. In this case, the end user s LAN is used to make system data available to users and archive the FMS data in real time. Figure 3 - Simple distributed system schematic This is the same monitoring system as the Simple System; the same physical parameters are being monitored. The main difference here is that the robustness features of the FMS software are being implemented. Buddy Monitor - Redundant monitoring system.

5 SQL Mirror (second) database - This is real-time writing of data to a second Mirror SQL database. Complex Distributed System These are commonly used by large pharmaceutical facilities where there are a number of manufacturing processes; typically these processes are on the same site but in different buildings. In this case, the end user s LAN is relied upon to facilitate system access and control. Figure 4 Complex distributed system schematic This is called a complex distributed system as all the components of the system software are distributed across the end users LAN and the monitoring LAN, they are also installed on different computers. Reliable Monitoring These different system examples should give an idea of the huge range of possibilities available from a dedicated monitoring system. In fact, no two systems are the same and the system may culminate in a combination of the examples detailed. Distributed software architecture and redundancy will deliver data that you can trust and peace of mind. TSI s FMS 5 FMS software is easy to operate and maintain. It has distributed architecture, built in redundancy and SQL main and mirror databases to enable you to build a reliable EMS.

6 TSI offers a suite of products including particle counters for your Environmental Monitoring System to ensure you get the perfect measurement every time, all the time. For further information visit: or tsi.emea@tsi.com About TSI Incorporated As an international leader in measurement technology for over 50 years, TSI incorporated ( partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science and contamination control. Visit our website ( to see our complete range of ISO compliant handheld, portable and remote airborne particle counters. Complimented by TSI s FMS 5 facility monitoring software they provide the most robust, simple to use and compliant certification and monitoring tools available.