Environmental Monitoring Systems (EMS) Remediation

Our consultants have experience working with Environmental Monitoring Systems (EMS) in various settings. A client identified gaps in the particulate monitoring of their ISO 5 and ISO 8 cleanrooms such as monitoring not being captured in real-time, and the need to have employees transcribe collected data into final form (as opposed to being printed in final form). Concuir was tasked with upgrading the legacy system to utilize new Met-One laser particle counters.

The new particle counters increased process efficiency and positioned our client to accommodate future particulate monitoring strategies such continuous monitoring and remote monitoring that is not reliant upon laboratory technician availability. Our consultants executed daily project activities, performed equipment calibrations, configured the new particle monitors, and ensured project deadlines were met. Concuir also developed and executed protocols including, but not limited to user requirement specifications (URS), design specifications (DS), installation and operation qualification (IQ/OQ) protocols and reports, and site acceptance test (SAT) protocols. In addition to the daily project activities and protocol development, our consultants also generated equipment life cycle documents to bring newly installed equipment online for cGMP manufacturing.

Ready to start a project?

Let's Connect

More Project Examples by Concuir

Filtration Process Scale-Up

A client asked our team to perform a scale up of their current filtration process for a drug product.

Read More

FDA 483 Form Remediation

Our client was issued an FDA 483 Form and tasked our team with the challenge to rectify and reform their current company practices.

Read More

100-Person FAT During COVID-19

A pharmaceutical manufacturing company came to Concuir with a predicament – they needed to coordinate and execute a factory acceptance test (FAT) for manufacturing equipment during a time when COVID-19 travel restrictions were ubiquitous.

Read More