Regionsapoteket Midtjylland produces and distributes pharmaceutical products, serving customers throughout the central Jutland region of Denmark, and the new monitoring system was installed at the new facility in Aarhus as well as the company’s site in Gødstrup near Herning.
With GxP regulatory compliance as a key objective, the CMS was supplied, installed and commissioned by Insatech, Vaisala’s local distributor, and partner for Regionsapoteket Midtjylland.
Data reliability in GxP environments
To meet the GxP regulatory requirements, the Vaisala viewLinc CMS was configured to monitor temperature, particles, humidity, and pressure, as well as alarms from water treatment systems, isolators, and safety cabinets in Regionsapoteket Midtjylland's medicine
production, handling, and storage facilities. The system logs measurement data from the respective measurement points as well as the use of the monitoring system (including entry log, alarm handling, communication errors, instrumentation errors, etc.), ensuring an accurate representation of the production environment at any given time.
With viewLinc, Regionsapoteket can verify and prove to auditors that medications are produced, stored, and handled under the correct environmental conditions. Data integrity is ensured through an ‘Audit Trail’ function in the viewLinc software, which leaves a trace of all activities and prevents data from being edited or manipulated.
24/7 monitoring
The viewLinc CMS enables Regionsapoteket Midtjylland to document production conditions around the clock. This is essential if there is any suspicion that a specific medication batch deviates from required storage and handling conditions. Therefore, viewLinc is a crucial factor in allowing Regionsapoteket to achieve data integrity and to guarantee the quality and safety of the medications that it produces.
With the viewLinc CMS, Insatech delivered a comprehensive monitoring solution consisting of data loggers and sensors strategically placed in cleanrooms, storage areas, laboratories, etc., either via lamp outlets or ventilation ducts. The system includes:
- 83 temperature measurement points in rooms, refrigerators, freezers, etc.
- 19 humidity measurement points in rooms and handling areas
- 19 particle counters, in production areas where personnel produce medicines. The limit is very low, and Insatech configured the system to activate lights and sounders in the rooms when alarm conditions are reached.
- 55 light towers that give an alarm if any limits are exceeded; indicating the criticality of the situation with a colour scale.
Insatech also installed 105 differential pressure transmitters in 13 industrial panels (approximately 210 measurements). These measurements indicate the differential pressure between two rooms, where an alarm is activated in viewLinc if the pressure thresholds are breached. For example, if production room air pressure becomes lower than that in the distribution corridor, contamination of the production environment may occur. Monitoring the differential pressure in these areas helps to ensure against this.
Data collection and reporting
Data from viewLinc’s distributed network of sensors is collected in the system’s server and presented in a user-friendly interface where it is also possible to print reports. The system logs data every minute, and if one or more parameters exceeds the allowed limit, the staff receive visual, acoustic, and SMS/email alarm notifications, allowing them to stop the batch immediately in critical productions. This ensures that the medicines are processed and stored within specified conditions.
In case of communication errors between the sensing instruments and viewLinc, data is stored locally in each device. Data storage capacity depends on the device logging interval, which is set up using viewLinc. Local memory in each device provides the data redundancy and integrity that is crucial for Regionsapoteket’s quality assurance and regulatory compliance.
Progress and successful installation
Throughout the installation process, Insatech provided advice, project support, quality control, network installation, and data integration – all crucial to the success of the monitoring system. Insatech also enabled collaboration with Regionsapoteket’s partners to guarantee successful installation and commissioning.
Following the successful completion of the project, Regionsapoteket Midtjylland issued the following statement: "We have been very pleased with our close collaboration with Insatech. The project manager has been a good collaborator and sparring partner. He has focused on being solution-oriented and helped us find the right solution when challenges arose."