Maintaining compliance within a pharmaceutical environment can be an extremely time-consuming task. Hundreds of hours are spent manually matching paper based logs, ensuring cleanrooms are staying below their maximum occupancy and manually tracking mobile assets.
If there’s any deviation or audit issues then the process of finding out who was involved with creating a batch from lots of different software systems can cause huge delays. Forward-thinking life science companies are overcoming these issues by using AIoT (Artificial Intelligence of Things) to automate compliance.
Operational Challenges of Older Facilities
Despite discovery processes being highly digitised, there can be challenges around tracking assets within the facility. The 3 main issues we see plant managers face are:
Manual Asset Tracking – Assets such as calibration kits, specialist containers and high value lab equipment are moved around many cleanrooms throughout the day. Manually tracking assets causes huge delays to production.
Manual Access Control – Controlling who enters specific cleanrooms ensures your GxP areas are kept up to standard. Using traditional badge systems can result in people entering areas they shouldn’t.
Batch Traceability – With no system in place to identify where all the materials came from, tracing the full genealogy of the batch can take time. This includes raw API material, excipients and packaging.
When you are not able to trace your compliance information this can increase the chance of findings & will cause delays to your batches.
Modern AIoT Capabilities in Pharmaceuticals
Using smart sensors on hardware and intelligent software will allow you to bring together your RFID, BLE and telemetry data. This gives you the ability to:
Automated Cleanroom Access & Personnel Insights
Smart access systems will use real-time data to compare employees against cleanroom access requirements. If there’s any issue with someone entering an area they shouldn’t be in, or exceeding the maximum number of people in the cleanroom the system will alert you.
Asset & Inventory Tracking
Using low energy BLE & RFID will give you real-time insights into where your assets are, how they’re being used and if they’re calibrated. This removes delays when searching for assets and ensures you’re not using uncalibrated tools.
Batch Genealogy
Creating links between people, assets, materials & environments will enable an AIoT engine to automatically create a full digital genealogy for each batch. Quality can easily confirm batch genealogy.
Most companies looking to modernise their facilities will use smart sensors and continuous monitoring to ensure they have the right systems in place to help with audits. You can find further information on how these systems work in our guide here.
AIoT Best Practice
When considering upgrading your systems within your pharma environment, it’s important to consider the following:
Ensure Full Genealogy – All data coming from your sensors should have a source that can be traced back to show it’s an immutable source.
Edge Resilience – Walls within cleanrooms and concrete can cause connectivity issues. Edge systems should have data stored and forwarded to ensure no data is lost.
Focus on Key Pain Points – Start with key areas causing delays, such as cleanroom access & high value mobile assets.
Conclusion
To succeed within the pharma industry you need to ensure you have agile systems in place. By using intelligent systems to replace manual tracking and paper logs, BioPharma leaders can massively reduce batch release times, ensure they are completely audit ready & maintain high standards of quality.
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