What Amnion Foundation Needed
Amnion Foundation is a non-profit biotech and biobanking organization in Winston-Salem, North Carolina. They provide donor-matched human cells and tissues that support regenerative medicine and cell therapy research. Because even minor shifts in temperature, humidity, or pressure can affect cleanroom integrity, Amnion needed real-time monitoring across both cleanrooms and controlled temperature equipment. They also needed accurate, dependable long-term data to support compliance requirements and day-to-day decisions across multiple departments.
How Rees Scientific's Unique Methodology
Rees began with a comprehensive walkthrough of the facility to understand Amnion’s workflows, cleanroom requirements, and compliance priorities. From there, the team collaborated with Amnion to design a monitoring program that met immediate needs while allowing for scalability.
The solution paired the Rees Environmental Monitoring System (EMS) for cleanroom temperature, humidity, particle counts, and differential pressure with monitoring of controlled-temperature equipment, including cryogenic freezers, -80°C freezers, -20°C units, and refrigerators. Cloud-based access provided automatic alarm notifications and made it easy to generate audit-ready reports, temperature traces, and event logs within seconds.
What Was the Result?
With the Rees system in place, Amnion eliminated manual temperature logs, reduced the risk of human error, and strengthened audit readiness while gaining real-time visibility into both cleanrooms and cold storage across its 3,000 sq. ft. facility. The team now operates on a single-node system supported by more than nine years of dependable data and relies on it daily across manufacturing, QC, QA, and facilities, including remote staff.
When an investigation or audit arises, Amnion can quickly generate the required documentation, helping protect biobank integrity and maintain long-term compliance.
Key Takeaways
- Detect Unexpected Issues: Use an automated system to ensure continuous coverage and receive immediate alerts if a disruption occurs.
- Prepare with Alarm Systems: Leverage automated notifications and real-time temperature and event reports to detect deviations and support audits.
- Eliminate Manual Logging: Transition to continuous monitoring to maintain facilities have reliable, consistent records.
- Built for Expansion: Design EMS coverage from the start to support simple, scalable growth.
To learn more about Rees' partnership with Amnion, read the full case study.
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