Customer’s Last Word: This user-friendly system saves us critical time in setup, data download and data analysis. The online capability gives me a real-time picture of the system, so I can see problems immediately and react instantly to prevent irreversible damage to temperature-sensitive materials.” — Facility Validation Engineer
Rapid expansion in the pharmaceutical industry has also brought with it increased regulatory inventory controls. In response, companies have started using state-of-the-art automated storage and retrieval systems, ensuring product integrity and accommodating high volume distribution. This has brought additional challenges to ensure the stored pharmaceuticals are kept within the strict temperature limits needed. The Fourtec DataNet wireless data logging system was installed to provide a reliable monitoring and reporting system, which successfully met all the company’s requirements.
Application: Wireless temperature monitoring of stored pharmaceuticals in a large warehouse
Organization: Leading global pharmaceutical company
Background
About the Customer:
Among the top 15 pharmaceutical companies in the world, this organization specializes in the development, production and marketing of branded pharmaceuticals and active ingredients. Recently they installed at a main production site, one of the top ten largest automated storage and retrieval systems in the world. The system has a volume of over 226,800 square meters and a capacity of 38,069 storage locations. PLC and control technology are used to manage the facility’s logistical system, automatically tracking and retrieving each inventoried item.
Key Customer Challenges:
Strict Regulations
- All temperature sensors must maintain an accuracy of ± 0.5˚ C
- Materials must be stored between 15 and 25˚ C to avoid spoilage
- Audits and validation directives demand comprehensive reports without data loss
Highly perishable goods
- Extremely sensitive materials can be ruined if exposed to high temperatures
Implementation Obstacles
- The vast scale and use of metallic material throughout the warehouse requires a very robust wireless data logging system. Each storage aisle alone measures 40 meters in height and 150 metres in length, providing a very limited clear space for data transmission.
- Measuring points span several floors, each floor with a complex system of electrical power grids and air conditioning units, using high voltage wiring.
DataNet Implementation:
Functioning as a backup and increasing the density of the facility’s existing built-in sensors, the Fourtec DataNet system ensures limitless monitoring points throughout every warehouse zone. Flexible onsite deployment, provides secure, real-time data backup.
System Configuration
– 85 Mini DataNet (DNL808) units with external NTC temperature sensors were installed and configured to 10 minute sampling rate and 20 minute transmission rate. Low and high alarm levels of 15 ˚C and 25 ˚C respectively were set. To accommodate the warehouse dimensions and ensure robustness of the DataNet network, 9 Mini Repeaters (DNR800) were also installed, for an extended transmission range.
Operational Procedure – A bi-weekly procedure driven by regulatory-compliance was implemented. Accuracy of all temperature probes are verified in a calibration bath before a one-week deployment throughout the warehouse. Specific deployment of each logger may differ depending on the season, after taking into account heat, humidity and air flow changes. Recorded data is then exported to Microsoft Excel ™ and a PDF report generated with alarm notifications defined. All units are retested to ensure their sensor accuracy was maintained. This process produces reports with a 3-year validation, satisfying the Ministry of Health and FDA regulations, as well as customer and internal audits.
Measurable Results:
- Zero data loss – The units’ internal memory stores data, no matter what transmission disruptions occur, allowing full data retrieval and transfer at any time.
- Standalone – The Mini DataNet’s long battery life allows the system to be deployed anywhere, without requiring electrical points or extension cables.
- Scalable and reliable monitoring – ZigBee technology overcomes transmission obstacles, automatically finding the most cost effective, efficient and secured data path to the PC. As units are constantly relocated, or Repeaters introduced to increase the network range, the intelligent system remains flexible and trustworthy.
- User-friendly software – In this complicated and large-scale environment, the DataNet software provides a clear visual map of the data network path, deployed units, alarms indications, and data strength and flow throughout the facility.
- Multi-setup – Rather than individually configuring each logger, 85 Mini DataNet units were configured with a single click, saving valuable installation time.
- Meeting regulatory requirements – Using the data export to Excel ™ feature proves data integrity and the intuitive Reports module provides transparent data records for achieving regulatory compliance.
Considering installing a temperature monitoring system? Please contact us to discuss your needs.
Article courtesy of Fourtec.
