How The Center for Regenerative Medicines (ZRM) Ensures GMP Compliant Cleanrooms Every Day
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How The Center for Regenerative Medicines (ZRM) Ensures GMP Compliant Cleanrooms Every Day

How The Center for Regenerative Medicines (ZRM) Ensures GMP Compliant Cleanrooms Every Day

GMP Production

21 Apr 2017

Project partner

The Center for Regenerative Medicine (ZRM) in Zurich is part of the Center for Clinical Research (ZKF), which is supported by the University Hospital Zurich and the University of Zurich. The ZRM combines basic biomedical research and clinical applications in the field of regenerative medicine. Regenerative medicine uses cell-based technologies for the treatment of tissue and organ damage (e. g. growing skin for burn victims).

The Project

The service offered by ZRM includes an integration of scientific and clinical research activities, such as early development, cell and stem cell biology, and others. The ZRM is reinforcing and optimizing synergies between R&D activities of the University Hospital Zurich and the University of Zurich in the field of innovative cell based therapies. In translational centers, the ZRM is supporting these R&D activities on their way to clinical applications.

Ever since the ZRM was opened in 2011 the University and University Hospital in Zurich strive for a regional and national competence and excellence in the field of clinical applications of regenerative therapies. The ZRM has to guarantee that the registration of clinical studies in the field of regenerative medicine will be carried out according to GCP (Good Clinical Practice). This requirement is being checked regularly by the competent authority e. g. Swissmedic and also international ones like EMA and FDA.

With modern GMP cleanroom and biobanking technology platforms, ZRM is meeting the needs for increasing demands for clinical applications of newly developed cell-based therapies. When building the facility, a highly specialized infrastructure was an important prerequisite for the successful clinical translation of research results in the field of tissue engineering and regenerative therapies. Thus the ZRM required GMP-compliant, fully monitored cleanrooms to start the production of cell-based technologies. Due to the confined space at ZRM, the cleanroom had to be integrated into an existing space – a room-in-room so to speak. The environmental monitoring system also had to be designed and installed with space-saving in mind.

Requirements for the Environmental Monitoring Solution:

  • GMP compliant according to national and international regulations
  • Complete security of the data
  • Integrity of data for long-term data storage compliance
  • Reliable «fail safe» alarming
  • Everything from a single source
  • Ease-of-use and easy to set up
  • A controlled environment including an audit trail and access rights specific to each use

How Environmental Monitoring Works at ZRM

The ECOLOG-NET series is ideally qualified for monitoring cleanrooms. All five ZRM cleanrooms that have been built are monitored by the ECOLOG-NET LA8 data loggers for temperature, relative humidity and differential pressure. There is a laminar flow cabinet in every single cleanroom, in which particle concentration is being measured. There are incubators in many of the cleanrooms in which temperature and CO2 concentration is monitored. Additionally, all refrigerators and freezers are continuously monitored for temperature. If a deviation occurs in any cleanroom or piece of equipment, the CMS immediately notifies the facility manager by e-mail, SMS or telephone, so that person can take action quickly.

The ZRM also uses the ECOLOG-NET data loggers to monitor the LN2 tanks in its storage rooms. The ECOLOG-NET data loggers are located outside the clean rooms in a control cabinet in the "technical area" so that they are easily accessible for maintenance and calibration work.

Alarming

The ECOLOG-NET data loggers enable around-the-clock accurate monitoring of the required parameters. Thanks to its LAN connectivity, it sends the logged data continuously, alerts immediately and is fully automated in case of a parameter deviation. A prompt reaction of the system is very important because in case of a deviation, e.g. the particle concentration gets too high, all employees inside the cleanroom have to stop their work immediately so that no samples are contaminated.

Alarming occurs both locally and centrally. First, each ZRM cleanroom has a local audible / visual alarm flash light. The particle counter in the laminar flow contains an additional LED warning light in the back panel; if everything is working well the green light is constantly on and turns into red as soon as an alarm occur. In addition, alarming occurs centrally. The alarm interface sends a warning signal to the company owned guidance system, and also by e-mail to the ZRM responsible person at that time. In result, ZRM has complete control of all current climate conditions around the clock.

elproLOG MONITOR-WebAccess

The software elproLOG MONITOR-WebAccess offers ZRM the practical possibility to compare and analyze all recorded data from all over the world. It enables the ZRM to create its own information cockpit for the central monitoring system. elproLOG MONITOR WebAccess is available either as a locally installed web application or as a cloud-based online service.

«The CMS from ELPRO provides us with a GMP-compliant monitoring solution for our cleanrooms. In case of a deviation of a parameter, e.g. the particle concentration, all our employees are immediately and reliably informed thus we can protect our samples from contamination. We are very satisfied that the monitoring system could be built so space-saving.» Mr. Kayser, Head of GMP at ZRM

Benefits for ZRM

ELPRO has provided the ZRM not only a safe and reliable Central Monitoring System for cleanrooms, but also an annual on-site calibration service. And of course, all the ZRM employees have been trained by ELPRO specialists.

At a glance – customer advantages:

  • Reliable monitoring around the clock
  • Deviations of parameters are immediately alerted
  • Monthly documentation
  • Redundant and reliable system in case of electricity failure: the system still measures and records
  • GMP and GLP compliant (GxP compliant)

To learn more about Central Monitoring Systems for GxP environments, read the white paper Central Monitoring Systems 101: Easier Management and Better Control of Critical Assets

In this paper you will read about system design, flexibility, sensors, redundancy, software and what questions to ask a CMS vendor if you're looking for a system that fits your environments. 

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