Vianex Plant C, one of the largest sterile injectable lyophilised production facilities in Europe, operates under the strictest EU Good Manufacturing Practice (GMP) requirements from its site in Pallini, Attica, Greece. With a production capacity of 10 million vials per year and 10 lyophilisers across 217 sq.m. of dedicated production space, the facility deployed 92 JRI devices: 91 Nano SPY data loggers and 1 LoRa SPY logger, all connected to the JRI-MySirius cloud monitoring platform to ensure continuous, automated environmental surveillance across all critical areas.
When Product Quality and Patient Safety Demand Continuous Monitoring
Vianex Plant C manufactures sterile injectable and lyophilised medicinal products for domestic and international markets. In this environment, maintaining precise control of environmental conditions throughout manufacturing, storage and distribution is essential. Any undetected deviation puts product quality, patient safety and regulatory compliance at risk.
As a GMP-certified facility, Vianex Plant C required a reliable and efficient temperature monitoring system covering all critical areas, storage conditions and GMP equipment.
Continuous environmental surveillance was not simply a regulatory requirement. It was a direct safeguard for the quality of every product leaving the site.
Demanding Technical and Regulatory Constraints
How did Vianex Plant C address its environmental monitoring requirements?
By deploying 91 Nano SPY data loggers and 1 LoRa SPY logger, all connected to the JRI-MySirius cloud platform, the facility established continuous automated surveillance with multi-channel alarm management and complete data traceability, in full compliance with EU GMP data integrity principles.
The monitoring system had to meet five key requirements identified by the site’s quality and validation teams. Continuous monitoring and alarm management were essential for real-time detection of any environmental deviation. Reliable data recording and traceability were required to support audit readiness.
Easy access to monitoring data was necessary for quality teams in day-to-day operations. The system also had to support qualification and validation activities, and cause minimal disruption during both installation and ongoing operation.
These five requirements directly shaped the selection criteria applied when evaluating available solutions.
“The JRI monitoring solution provides reliable temperature monitoring and excellent technical support, helping us maintain our GMP requirements with confidence.”
Alexandros Giannikopoulos, Validation Manager Plant C, Vianex
The JRI Solution: Nano SPY and LoRa SPY at the Heart of a Complete GMP Monitoring System
When selecting a temperature monitoring solution, Vianex Plant C evaluated five main factors: compliance with pharmaceutical regulations and GMP requirements, reliability and accuracy of measurements, ease of installation, secure data management and traceability, and a user-friendly software interface.
A decisive factor in choosing JRI was the high-quality technical support and after-sales service provided by the local distributor, already an established partner of Vianex. This combination of technical performance and trusted local expertise made JRI the right choice.
The deployment covers all critical areas, storage conditions and GMP equipment. 91 Nano SPY data loggers monitor temperature, relative humidity and differential pressure simultaneously. One LoRa SPY logger completes the installation for temperature monitoring. Both products are part of JRI’s pharmaceutical monitoring solutions portfolio.
The Nano SPY is a compact wireless data logger designed for critical environments requiring precise, high-frequency environmental measurements. Its wireless transmission feeds data directly to the JRI-MySirius cloud platform. Internal memory ensures continuous recording in the event of any communication interruption.
The LoRa SPY connects to the LoRaWAN long-range radio network, ensuring reliable data transmission across the full extent of the facility.
The JRI-MySirius Platform: Centralisation and GMP Compliance
All data collected by the 92 loggers is centralised on the JRI-MySirius. This Software-as-a-Service (SaaS) solution provides Vianex Plant C with a real-time dashboard for remote visualisation of environmental conditions across all monitored areas and equipment.
Alarm management is fully configurable. When a threshold is exceeded, immediate notifications are sent to on-call teams via the MySiriusAlert mobile application. All data is securely archived, guaranteeing long-term integrity aligned with GMP data integrity requirements.
The platform automatically generates traceability reports ready for quality audits, supported by a complete activity log. The Calibration module ensures metrological management of sensors in compliance with ISO 17025 requirements.
The user-friendly interface, explicitly highlighted by Vianex Plant C as one of the key advantages of the solution, enables quality and validation teams to access monitoring data and documentation with speed and confidence.
Before and After: The Impact of the JRI Deployment
| Criteria | Requirement identified | JRI Solution | Benefit |
|---|---|---|---|
| Continuous monitoring | Continuous monitoring required across all critical areas and GMP equipment | Automated 24/7 surveillance of temperature, relative humidity and differential pressure | Uninterrupted environmental control |
| Alarm management | Real-time alarm management required | Fully configurable multi-channel alerts via JRI-MySirius | Immediate notification on any threshold exceedance |
| Data recording and traceability | Reliable recording and traceability required for audit readiness | Secure archiving with complete activity log | Full GMP data integrity compliance |
| Data access | Easy access to monitoring data required | Real-time dashboard and mobile access via JRI-MySirius | Instant visibility for quality and validation teams |
| Qualification support | Support for qualification and validation activities required | IQ/OQ/PQ-compatible documentation and reporting | Simplified validation dossiers and inspection preparation |
| Installation | Minimal disruption required during installation and operation | Wireless deployment, no impact on ongoing GMP operations | Seamless integration across all monitored areas |
Concrete Results for Pharmaceutical Quality and Compliance
The JRI solution addresses each of the five requirements identified by Vianex Plant C.
Environmental conditions across all critical areas, storage zones and GMP equipment are now monitored continuously and simultaneously across three parameters: temperature, relative humidity and differential pressure.
Two advantages stand out for the Vianex Plant C team. The user-friendly interface of JRI-MySirius allows quality and validation professionals to access monitoring data and traceability documentation quickly.
The high-quality technical support provided by the local JRI distributor ensures responsive assistance whenever needed. Together, these two strengths enable the site to maintain its GMP requirements with confidence, as stated by the Validation Manager himself.
An International Dimension at the Service of Pharmaceutical Manufacturing
Vianex Plant C serves both domestic and international pharmaceutical markets. This deployment illustrates JRI’s ability to support pharmaceutical manufacturers across Europe with solutions designed for EU GMP compliance, backed by a network of established local partners providing expert technical support close to each site.
With offices and teams across Europe, the Americas and Asia, JRI supports more than 15,000 customers worldwide in protecting their sensitive products and maintaining continuous regulatory compliance.
Towards an Extended Environmental Monitoring System
Following this successful deployment, Vianex Plant C is planning the next phase of its monitoring programme. Safety probes are ready to be integrated into the existing JRI-MySirius system to enable flammable gas monitoring, extending the environmental surveillance scope of the site.
Regular laboratory sensor calibration services can further sustain long-term measurement accuracy and GMP compliance. This ongoing collaboration reflects JRI’s commitment to supporting pharmaceutical manufacturers from initial deployment through to daily operational support.
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