Eamon McCann, CTO, the Argility Technology Group, outlines some of the challenges facing the pharmaceutical and medical sectors with regards to thermolabile products.
The South African Pharmacy Council (SAPC) strictly governs the procurement, storage, and distribution of thermolabile – defined as a product or substance readily destroyed or deactivated by heat – pharmaceutical products. These rules are in accordance with the World Health Organisation’s (WHO) specifications.
Companies that store and distribute these products must ensure that they comply with SAPC GPP (Good Pharmacy Practice) regulations of ambient, fridge or cold room temperatures, making it essential that the temperatures are constantly monitored in order to remain within optimal range otherwise the efficacy of the products can be compromised and a broader range of pharmaceutical products cannot be stored.
It’s also necessary to guarantee adherence to compliance requirements including diligent temperature recording and history so implementation of an automated system capable of monitoring and raising timeous alerts is crucial.
The significance of the Internet of Things (IoT)
IoT has opened-up a world of possibilities in the medical and pharmaceutical arenas and Argility’s SkyData platform provides IoT remote monitoring and alert capabilities for devices at designated fridges and storage units.
What does SkyData do?
The platform empowers companies to connect devices and deploy applications that enable automated data collection and analysis, remote device management, contextual and real-time decision making. It permits businesses to monitor and manage any number of data points presented from various devices and may be used to scrutinise and administer anything on a dashboard from temperature; humidity to: utilities – electricity; water; gas usage and assets such as vehicles, billboards, machinery and more.
In the pharmaceutical use-case the platform monitors devices that are connected to the fridge to monitor the internal temperature and the external ambient temperature.
Once data is communicated from the IoT devices Argility’s Skydata platform will take care of device management, business rules, security, alerts, notifications, dashboards, and reporting as well as the storage and management of historical data.
Given the device agnostic nature of the SkyData IoT platform, any future business monitoring needs can be satisfied by deploying additional IoT devices and sensors into the physical environment which can then feed additional data points into the platform without requiring another software platform. SkyData can monitor humidity, pressure, CO2/air quality, gas, water and electricity usage, GPS location and more.
Multiple notification mechanisms are available allowing SMS, email and mobile app. push notifications to be configured for any level of alert severity, this typically managed from low through to critical levels of alerts.
Reporting – leading to compliance
Access to real time dashboard and daily/monthly exception reports are made available to designated people.
Three standard reports are distributed daily by email to either designated stores: regional or national facilities:
- Exception summary report – provides a summary of min, max, average temperature per asset, including recent alarms raised.
- Alarm report – provides a list of threshold breaches as per the defined rules
- Daily temperature report – list of the temperature readings for the preceding 24 hours – compliance report for inspectors.
Data is stored on SkyData for a period of three years and can be made available when required.
Key Features and Benefits
- Web based administration, configuration dashboard and third-party device management.
- Secure User and role-based authentication and notifications.
- Scheduled and automated extracts and reports.
Multiple pre-integrated wireless and wired devices and sensors.
- Communicate wirelessly via long range battery powered device.
- No connection required to electrical circuit – fridge can be moved without affecting the device.
- Cross platform mobile friendly data visualisation dashboards (Android and iOS)
- Dashboard summaries and drill down features
- Ability to view data across multiple stores
- Ability to view detailed data points within a specified store/location
SkyData is functionally rich and an application fit for many environments including pharmacies; hospitals; clinics; veterinary clinics and more.
Click here for a detailed case study – Informed Decisions and SkyData partner to deliver greater efficiencies for Pharmaceutical Manufacturing Laboratories.