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European Pharmaceutical Contractor

Self Control Systems

Jean Bédard from Alternatives Technologie Pharma Inc looks at automated temperature monitoring systems and how technological tools can ensure complete cold chain visibility.

As per regulations and guidelines on cold chain and storage and distribution practices, the environmental conditions during transportation of pharmaceutical products should be continuously and reliably documented.

Technological systems with attractive features are now becoming increasingly widespread. These systems provide reliable, safe and secure temperature monitoring solutions to the pharmaceutical supply chain. Furthermore, such monitoring solutions can be adapted to the varying requirements of the supply chain stakeholders, such as pharmaceutical laboratories, wholesalers, warehousers, distributors, transporters and third-party logistics providers and pharmacies.

RELIABLE MONITORING SOLUTIONS: AUTOMATED TEMPERATURE MONITORING

Automated monitoring systems allow data to be recorded accurately and in real-time, with results displayed in custom reports, charts and graphs. Furthermore, automated monitoring systems hold priceless advantages compared with measurements taken by hand. Automation of temperature monitoring avoids human error factors and reduces the costs and time associated with chart or manual recordings, while increasing accuracy.

Access to the monitoring system should be secure, and such monitoring solutions should provide multi-level user access and rights. Audit trail compatibility is another feature that should be present on the monitoring solution. The reporting of outof- specs and alarms can be done through automatic and electronic record keeping, sensor malfunctions can also be reported automatically. Alarm limits are set by authorised users to alert responsible staff via personnel alarms in case of out-of-specs or incidents.

Monitoring should be continuous and loss of data is not acceptable. Sensors should buffer and collect data continuously, even during network outages, with buffered data being sent to the host server when the connection is re-established.

WEB SOLUTIONS: A SAFE AND SECURE WEB ENVIRONMENT

Web-based systems enable the use of online databases and provide secure access to authorised users. While automated monitoring systems perform complex operations, user-friendly web systems allow users to benefit from optimal performance.

Monitoring systems typically operate over existing local area networks (LAN) and wide area networks (WAN), using TCP/IP, and should provide multi-user, multi-building, multi-site capability. A system dashboard traces operations and activities, displaying and allowing followup of all alarms; data can then be compiled into preformatted reports.

Automated monitoring systems provide a vast new array of analysis reports that can be accessed easily from any workstation. Reports based on time, date, activity, input, event type or multiple criteria can be generated. All parameters related to sensors and alarms can be configured and customised by users. Alarms include audible, visual and messaging signals, in which authorised users can be alerted via email, phone or text message.

WEB SOLUTIONS: A COMPLETE MANAGEMENT SYSTEM

Monitoring solutions should incorporate a complete management system including user management, sensor inventory management, sensor calibration management, site (or building) management, reader assignment by site, sensor or tag assignment by container or location, alarm set points management and alarm recipient management. The system should also provide for easy and rapid searches by audit trail, document (way bill), sensor or tag, site, user or date.

WEB SOLUTIONS: ONSITE VERSUS VENDOR-HOSTED

Monitoring systems can adapt to specific environments, for example multiple site, small-scale facilities versus large-scale facilities. There are two main set-ups for monitoring systems: monitoring systems hosted onsite (onsite system) by the customer, and monitoring systems hosted by the vendor, where monitoring is a ‘service as a solution’ (SaaS).

An onsite monitoring system is generally found in large companies or laboratories where temperature monitoring is a critical part of operations. It requires day-to-day management of the monitoring operations, and as a consequence, the staff, resources and skills to perform it internally. In such a scenario, the monitoring system is fully hosted and managed by the customer.

Vendor-hosted monitoring systems (SaaS) offer an alternative for organisations or laboratories that do not have the staff or resources to manage such a monitoring system internally. In SaaS, the monitoring software and database are hosted and managed by the vendor, and the customer is only required to install the hardware (sensor and reader) at its facility. The customer has access to its dashboard and data through a common web portal and an individual web account.

MONITORING SOLUTION: WIRED VERSUS WIRELESS

Wired or wireless networks of sensors can be found in commercial monitoring systems. Systems with combined wireless and wired components can be run as needed by the facility, and enable complex monitoring operations.

Wired sensors provide reliable data recording; however they can also create complex and costly wiring operations, and inhibit easy changes to the network configuration. Monitoring networks with wired sensors are limited in the adaptability of the monitoring architecture, complicating equipment moving or warehouse re-configuration, and potentially incurring additional costs.

Automated monitoring systems can be 100 per cent wireless, being supported on a local area network. Wireless systems are easier to install, and cut down on the cost and time of installation and maintenance. In a complex or extended monitoring scenario, wireless configuration should be tested to avoid dead zones or wireless transmission concerns. Wireless communication mode mainly uses radio frequency, with WiFi mode being available on some systems.

New incoming technologies now bring powerful and efficient wireless systems where:

  • Self-powered sensors are more powerful and require only one central reader
  • Sensors also act as data loggers
  • The wireless network is self-adaptable and self-healing, and sensors act as relays
  • The wireless network automatically detects and incorporates new incoming sensors

ADAPTABILITY AND EXPANDABILITY

Depending upon your facility and operations, it may be extremely useful to implant a monitoring system that gives a high level of adaptability and expandability.

Automated monitoring systems should be tailored to your operations and needs, and should also be easily expandable. Double alarm limits (high-high, high, low, low-low) may be useful for more efficient monitoring of storage conditions. Connection to the security alarm panel (and company) may also be required in addition to the internal alarm types. Customised graphical interfaces for the monitored storage sites could be another requirement – all these features should be reviewed when looking for a monitoring system.

Changes in your storage and warehousing configuration, moving of thermal equipment, and the addition of new storage sites should be possible in an easy and cost-controlled way, by the selected monitoring system. The new 100 per cent wireless technology enables the monitoring system to be expanded more easily, and at a reduced cost.

COMPLIANCE

Monitoring solutions should incorporate software that is compliant with 21CFR part 11 on electronic recording and signature. Automated monitoring systems should meet today’s toughest standards and provide complete compliance documentation as required by the FDA, Health Canada, AABB, USDA and other regulatory bodies.

Furthermore, automated monitoring systems should be supplied with compliance services and documentation: Standard Operating Procedures (SOPs) on installation, use, backup and de-installation operations, Installation Qualification (IQ) and Operational Qualification (OQ). When proposed as SaaS, the monitoring system should be qualified at the vendor’s site.

Additionally, the installation of a monitoring system and temperature sensors in ambient storage or warehousing areas should be related to seasonal hot and cold points as determined by a temperature distribution mapping study. In the same way, sensors for monitoring thermal equipment should be installed by following the appropriate rationale.

As a consequence, looking for a monitoring system goes well beyond hardware and software. It also includes looking at a complete installation, including system validation, sensor calibration and thorough personnel training.

MAINTENANCE AND SUPPORT

Any monitoring system should be provided with maintenance, support and warranties. As equipment crucial to compliance with industry regulations, a 24/7 technical support plan should be available for your selected monitoring system. Moreover, sensor calibration should be performed annually, without major monitoring disruption; ideally, ‘no worries calibration’ performed by the exchange programme should be favoured to minimise any monitoring disruption. Finally, warranties should be given on software and hardware.

TOWARD A GLOBAL COLD SUPPLY CHAIN MONITORING SOLUTION

New wireless technology enables the buildup of a global cold supply chain monitoring and tracking solution. Wireless monitoring solutions using mesh configuration enable the monitoring of both storage installations and movable shipments. Fixed storage facilities are monitored as usual by using fixed wireless sensors and readers.

Moving shipments can also be equipped with wireless sensors with the following benefits:

  • Wireless sensors monitor and store temperature data (when not in the range of communication with a reader). In this scenario, sensors act as data loggers
  • Wireless sensors are automatically detected by wireless readers for communication and data downloading
  • Both readers and sensors have unique identification serial numbers (direct or in a barcode), which enable an indirect localisation of sensors and products
  • Referencing documents can be related to product shipments or sensors (by barcode)

This new automated wireless monitoring system provides a very efficient tool to track the temperature through the cold supply chain, thus enabling the monitoring of product temperatures at storage/ warehousing locations throughout the supply chain, to track products and product temperatures in pallets and distribution shippers, and to identify products and product localisation throughout the supply chain.

CONCLUSION

New technologies provide advantageous integrated, automated monitoring systems which create low-risk storage environments for sensitive materials. Implementing such technologies allows the development of tools that ensure quality and safety standards are met. They should be part of a strategy to improve pharmaceutical storage and distribution.

For temperature, humidity, differential pressure or other parameters, selecting the right monitoring system (hardware and software) for an environment and needs is crucial when installing a safe and paperless environment for the pharmaceutical and life science sector.

Automated monitoring systems safeguard valuable research, effort and products, reduce losses and limit exposure to risk, and save energy and resources by providing a streamlined automated data collection.


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Jean Bédard is CEO of Alternatives Technologie Pharma. He holds an MBA in Bio-industry Management and is part of many associations and organisations related to science, cold chain and track and trace. Since 2003, he has headed an impressive team of cold chain experts at Alternatives Technologie Pharma, where activities are based around five major aspects of cold chain and track and trace management: regulatory compliance services; technical services (thermal mapping and studies); environmental monitoring and data logger management solutions; design, test and qualification of cold chain packaging and cold chain packaging supplies. Jean has managed more than 100 complete cold chain compliance programmes for many pharma, biotech, wholesalers, 3PLs, transporters, CROs, CMOs, hospitals, blood banks and other companies.
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