Last month we discussed the use of AR/VR devices to document a batch production run of cell therapies or biological molecules in a clean room. This month we will explore the technical specifications for these devices to be both robust and compliant in this unique and challenging environment.

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First off, the device must be able to be sanitized,disinfected, or otherwise sterilized. Being a complex electronic device, the modes used to achieve sterilization are limited to chemical means. Gamma irradiation and autoclaving would irreparably damage the unit. It should also lend itself to being tested sufficiently to verify sterility.

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The device should have a high-resolution, heads-up display to clearly visualize critical information such as batch records, standard operating procedures (SOPs), and equipment status. This heads-up display should function not only to display information but should also lend itself to entering critical observational data and well as capturing and verifying material lot information.

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The device needs to have multiple avenues to capture and input data, including both still and video image capture, and barcode/QR code scanning capability. The video recording capabilities can be used to document and verify process steps, as well as form the basis for any root cause analysis investigation. The barcode/QR scanner would track time in and out of incubator,time for the execution of each step, and act as the primary method of recording lot specific information for both consumables and identifying and recording equipment used during the process.

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To ensure data integrity and compliance with regulatory requirements, the device should have robust data encryption and security features and comply with relevant regulatory requirements including 21 CFR part11 which governs electronic records and signatures, as well as the ability to integrate with manufacturing systems like CultureTrax.

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 A key component for any AR/VR system to be successfully implemented in a clean room manufacturing environment is that it has robust and repeatable hands-free operability. The operator must be able to enter data,record observations, and otherwise manipulate the device in all aspects of the manufacturing process repeatably and reliability. It needs to be able to integrate with existing manufacturing systems to access and update batch records and other relevant data. Finally, it needs to have a battery capacity that would be twice what would be required for a normal manufacturing run as well as be durable enough to handle 1-2 years’ worth of manufacturing runs.

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It is possible that the device needed to meet these specifications will be, at the very least, a highly modified version of an existing product. However, it’s also equally likely that the piece of technology will need to be stripped down and modified, or even built, from the ground up. When we did our original customer discovery for CultureTrax we found that there wasn’t a software application on the market that could record data,link data, and inform workflow decisions for a science as complex as stem cell culture, so we built one from the ground up with input from academia and industry in the Madison, WI area. The same is likely to be true for the hardware device.

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Most importantly, these specifications must be verified and fine-tuned by working closely with a clinical cell manufacturer to ensure that the device addresses the needs correctly and fully. Software developers call this the Agile method, where the product is built with the direct input of the customer. Working in this manner will not only ensure the correct set of features and specifications but will also foster a closer relationship between the customer and the vendor, which will provide the vendor with a distinct advantage in the marketplace.

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By meeting these specifications in this manner, an AR/VR device could effectively document a batch production run of cell therapies or biological molecules in a clean room, eliminating the need for second-person verification while ensuring compliance with regulatory requirements, and the manufacturer of this device could be the first to market with arguably the most disruptive technological innovation for manufacturing in this space.

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