Centralising and preserving collections of heat-sensitive products
Cell&Co specialises in the management of GMP (Good Manufacturing Practice) and biological and chemical products, and meets the needs of its industrial customers and life science laboratories by using the JRI-MySirius solution to ensure secure storage conditions and traceability of temperature data.
GMP compliance and strict adherence to the cold chain
Cell&Co‘s role is to ensure the secure management of samples and their associated data throughout their life cycle: collection or production, transport, reception, preparation, analysis, storage, dispatch and destruction.
With two GMP plants, Cell&Co offers mirrored storage capacities from -196°C to +20°C to primarily support its customers with services requiring increased temperature monitoring for :
- GMP product management, from secure storage for cell banks and cold chain logistics to secondary packaging
- Biobanks
- Clinical sample management
The products entrusted to Cell&Co include cell banks, active ingredients or medicinal substances and excipients, as well as products of biological or chemical origin from R&D materials, clinical trial samples, cohorts and collection back-ups.
In order to maintain their integrity, Cell&Co not only has to deal with temperature monitoring issues. In addition to monitoring storage conditions over the range -196°C to +5°C and ambient temperature, the level of nitrogen is also one of the parameters to be monitored.
Deeply committed to the search for innovative technical solutions and reliable tools, Cell&Co chose to deploy the JRI-MySirius cold chain monitoring solution to provide even greater traceability and quality in the monitoring of samples and sensitive products.
” We were looking for a temperature monitoring solution adapted to our technical and regulatory constraints.
A reliable, robust and durable system that could be fully configured (user profiles, alert thresholds, alert cascades, etc.), consulted remotely and capable of generating automated reports. JRI’s MySirius solution meets all our criteria, without exception.
Sofien Dessolin, Chairman Cell&Co
Temperature monitoring for efficient quality assurance
At the Clermont and Pont-du-Château sites, more than 100 measurement points have been deployed:
- freezers at -80°C
- nitrogen tank
- storage areas
- isothermal chambers (+15/+25°C; +2/+8°C; -15/-25°C)
- freezers -20°C
- refrigerators +5°C
All the equipment is monitored by LoRa SPY connected sensors. A wireless solution, the LoRa SPYs have a display so you can view the measurement in progress both on site and remotely via the application. Their internal memoryprevents data loss in the event of a communication fault.
Given the size of Cell&Co’s sites, a long communication range was needed to cover all the equipment and enable data to be uploaded to the JRI-MySirius cloud application.
The operational team can supervise and manage data and alerts. In the event of alarms, the LED on the LoRa SPY sensor turns red to warn operators locally. On-call teams can view and manage alarms from the MySiriusAlert mobile alarm management application.
To comply with FDA 21 CFR Part.11, the Advanced level of the JRI-MySirius application enables data to be consulted over a rolling 18-month period, with archiving for 10 years. All actions, alarms and events are tracked in a comprehensive activity log.
JRI-MySirius account administrators can customise each user profile by granting à la carte rights. What’s more, updates can be deferred to take the time to qualify new application features before installing them.
” The JRI-MySirius solution enables us to share temperature data with our customers automatically. What ‘ s more, we can carry out quality checks to certify pharma products.
Sofien Dessolin, Chairman Cell&Co
Operational maintenance and metrology: services at the heart of quality
With the Maintenance module integrated into the JRI-MySirius application, Cell&Co technicians can manage preventive and corrective maintenance operations for their fleet of temperature recorders.
As far as metrology is concerned, JRI carries out laboratory checks on the probes installed. Enclosure mapping services are provided by CIET, a company which, like JRI, is a member of the MMS Group – Metrology & Monitoring Solution.