What is the image that first comes to mind when we hear Pharma Manufacturing – gleaming steel vats, complex equipment, workers in white overalls and masks all pointing to a cleanroom environment. Cleanrooms are fundamental to the pharmaceutical industry and particle counters are an integral part of creating and maintaining cleanrooms. As we started building industry-specific IIoT solutions with Phizzle’s EDGMaker stack, a solution that automated particle counters was a no-brainer due to the nearly instant ROI and the proliferation of particle counters not only in pharma manufacturing and R&D labs but also in Healthcare, Food Manufacturing, and High-tech Manufacturing to name a few. EDGMaker’s Digital Air Series is the true solution for automating particle counters.
Pharma Manufacturing is one of the most complex IIOT use-cases due to the complexity of the equipment and instruments used in the research and production of modern-day Pharmaceuticals. It is a highly regulated industry with stringent requirements for the security and auditability of scientific data.
Any IoT solution for this industry should have the ability to do the following:
1. Monitor, operate and collect scientific data from the equipment
2. Provide workflow capabilities that enable manual SOPs to be digitized including calibration checks, e-signatures, and integration with related systems like LIMS, MES
3. Data integrity and auditability that ensures validity and provenance of data
The current processes in place for most customers with a fleet of particle counters from multiple manufacturers is very labor-intensive. A typical Pharma operator would start the day downloading from LIMS or MES the sample schedules for the day including the locations, sample parameters, number of tests, continuous runs, and flushes. The operator then selects a particle counter from their available equipment. The operator then goes to each location mentioned in the schedule with the selected particle counter and has to manually enter the sample parameters, tests and all the other info into the particle counter to run the samples and print the data onto thermal paper and sign the printout and attach it to the appropriate forms in the Log file. After all the samples are done the operator then heads back to the workstation to manually enter the results data into the LIMS or MES system and photocopies the results and hands the files over to the QA department. QA then has to again recheck all the data and ensure SOP guidelines are met. This is a very labor-intensive process and prone to errors.
That brings us to the second aspect of operating particle counters – workflows. The workflow as defined by SOPs is very extensive. It starts with checking the calibration data to checking the physical aspects of the particle counter tubing to making sure there are no obstructions to running a flush when moving from a lower-grade room to a higher-grade room etc, including signature requirements, manual data entry and manual QA review requirements as outlined earlier.
Additionally, the regulatory requirements around particle counters require not only the collection of sample data securely and consistently, but also all aborted Samples and incomplete Samples must be recorded and the data collected when available. Some particle counters allow for the Display to be locked when connected to an IoT system but others allow users to operate the particle counter from the Display causing interruptions to the samples initiated remotely. Even in these cases, the data has to be collected and all operations logged and audited.
The EDGMaker Digital Air Series not only can monitor the particle counter’s status and health, but it can also control the particle counter by running samples, flushes, continuous runs etc. and collect all sample data by automating the whole process including exception handling to truly allow users to remotely operate particle counters. When the EDGMaker Digital Air solution is deployed an Operator’s day starts with opening the Digital Air UI on a tablet and finding the list of scheduled samples that have to run for the day. These scheduled samples have been imported from LIMS or MES system automatically through an API-based integration. The Operator then selects an available particle counter from the UI. The operator can run the sample with a click of a button once they are at the specified location – the calibration check is done automatically, a flush is automatically included in the workflow steps if the room grade change requires it, all the sample data is sent to the particle counter along with the command to start the sample and once the sample finishes the data is automatically collected and shows up on the Digital Air UI, which the Operator can review and provide an e-signature and move to the next location on the schedule. QA can also review the sample data and approve through the RBAC enabled Digital Air UI and the sample data is automatically synced to the LIMS or MES as applicable.
EDGMaker Digital Air completely eliminates paper-based record keeping and manual entry of data in multiple steps of the workflow reducing the total labor required to operate each Particle Counter from 1.3 person/device to 1 person/device. In addition to this, the standardization of data received from various models of Particle Counters and stringent security and auditability ensures data integrity and compliance avoiding costly investigations and fines and potentially having to dump or recall batches. The intuitive UI makes various users like Operators, QA, Admin, Audit have relevant and accurate data providing a great user experience.
The EDGMaker DigitalAir Series is a true solution that is process ready to remotely manage particle counters by ensuring reliable, consistent and compliant operations and scientific data collection and dissemination through out-of-the box integrations to various third-party systems.
-Vijji Suryadevara CPO & Head of Engineering (@s_vijji)