REAL TIME MONITORING SYSTEMS
The cleanroom environment is very dynamic with products and personnel moving and changing, thus contamination events can happen at any time. Real time monitoring enables you to know when the environment is not safe for building the products.
Particle shedding events are rarely predictable, and can happen at random times throughout the day. Monitoring this environment on a continuous automated basis will help to catch these types of issues before they get out of control or affect production. Millions of dollars worth of products can pass through a cleanroom on a daily basis depending on the type of facility. Finding out about a contamination problem a day or two late could be an expensive and/or catastrophic situation.
In addition, the ability to recall historical data is a very valuable tool to have. Reports serve as records that can be used to present supporting data to customers, government organizations, and regulatory committees.
Acumen can assist you with a complete environmental monitoring system via sensors and software packages available through TSI.
Robust Facility Monitoring Software
TSI FMS system is an advanced, reliable, and user-friendly monitoring software suite that features a truly distributed architecture. High availability databases and hot standby system failover functionality assures compliance and peace of mind. Multiple system inputs are supported.
Typical inputs include:
+ Airborne particle counters (multiple manufacturers)
+ Analog inputs
+ Temperature and humidity
+ Differential pressure
+ Air velocity
+ 4-20mA inputs
+ Digital Inputs
Ease of Use
An intuitive, user configurable interface means immediate visibility of real-time data. Single mouse click access to historical data and report generation leads to reduced operator training, immediate data access and improved process control.
Multi-level maps display the last recorded value for each instrument and show real-time icons in Red for Alarm, Yellow for Warning, Green for Okay and Blue for Instrument Failure. Simply click on the instrument icon for instant, detailed information.
FMS 5 supports multiple system outputs like beacons, sounders, SMS text, email, auto-dialers and reporting are supported. Operators and managers are immediately informed of an event. This information aids in root cause investigations, process validation and improved product quality.
Graphing and Reporting
FMS comes with its own report generation tool. This allows users to create customized reports to meet your needs. Where more advanced reporting is required, third party tools can be easily deployed to use with FMS 5 databases. All collected data can be turned into useful process information via powerful FMS 5 reporting and graphing tools. Critical reports can be generated each day, and auto reports can be created based on recorded events.
Need a Buddy?
FMS offers a unique Buddy (Automatic Hot Standby) system option for built-in system redundancy. This completely integrated back-up system resides on an alternate computer. If anything happens to the primary FMS 5 system, the Buddy automatically takes over, continuing to collect secure data. No manual intervention is required in the event of a computer failure, meaning no system down time, no lost validated data, and peace of mind.
21 CFR Part 11
FMS 5 is compliant environmental monitoring system software for the Pharmaceutical, Medical Device and Life Science industries. All software development activities at TSI follow the ISPE GAMP® lifecycle model. FMS 5 is assigned current GAMP® category 4 as configurable software. It is specifically intended for use where compliance to EU GMP Annex 1 and FDA cGMP aseptic processing guidance is required.
FMS 5 enables compliance to the FDA 21 CFR Part 11 ruling. Full audit trail, password aging and lockout after failed logins, ensures secure, tamper proof data archiving and reporting. System security is easily configurable. User groups allow users and managers appropriate levels of system access.
Full project based validation documentation based on ISPE GAMP® guidelines is available and tailored to meet your requirements.
+ User Requirement Specification (URS)
+ Functional Specification (FS)
+ Configuration Statement (CS)
+ Factory Acceptance Test (FAT)
+ Installation Qualification (IQ)
+ Operational Qualification (OQ)
Acumen Technology is proud to offer real time monitoring systems produced by TSI Incorporated, a recognized world-leader in real time monitoring systems and airborne particle counters.
TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, health and safety, indoor air quality, air flow, fluid dynamics and biohazard detection. With headquarters based in the U.S. and field offices throughout Europe and Asia, TSI has established a worldwide presence in the markets they serve. Every day, our dedicated employees turn research into reality.