Pari Sanghavi, senior director, life sciences supply chain and manufacturing at Cognizant and Jim Lehane, global leader business development at Zenith discuss how manufacturing must change following Covid-19.
AR Manufacturing
Pharmaceutical and other life sciences products require some of the most complex, precise, and highly regulated processes in the manufacturing world. They require close coordination among highly skilled workers using expensive and specialised equipment. Following and documenting adherence to Good Manufacturing Practices (GMP) and proper manufacturing protocols is mandatory for life sciences manufacturers.
The social distancing requirements to contain the Covid-19 pandemic, and the associated supply chain disruptions, has meant rapid and sudden challenges to life sciences manufacturing. Here are four ways digital tools and processes can meet these emerging needs.
Remote production support
Pandemic-related shutdowns have caused some manufacturers to reduce their on-site support staff by as much as 75%. Properly configuring and managing equipment, as well as verifying correct manufacturing processes, with only critical workers on-site, requires increased use of video conferencing, as well as artificial reality and virtual reality (AR & VR). Critical workers such as hands-on technical staff, are being trained to undertake verification and data gathering tasks differently to allow strictly clerical employees to work remotely.
However, the larger, more long-term challenge, is fully digitising the batch records that follow each production lot through each stage of the manufacturing process. Some of the needed data sits in enterprise resource planning (ERP) platforms or within various production and test equipment. The full data set is rarely recorded in a historical database utilised by an overall manufacturing execution system (MES). That means some form of paper record must be created when, for example, raw material moves from the testing lab to the factory floor, and as production staff members verify proper performance of production processes.
With social distancing and more remote work, what used to be quick, person-to-person handling of verification paperwork may now require cumbersome and time-consuming printing, signing, scanning, and emailing. Some life sciences companies are speeding the deployment of MES systems, but this can take months or years given the complexities of life sciences manufacturing. A light form of MES such as ‘Virtual Form Flow’ can enable rapid digitalisation of manual processes as an interim step towards fully Electronic Batch Records or eBR. Known as “paper on glass, “this has the added benefit of enabling remote sign-off of the batch record during pandemics that require social distancing.
Remote/distributed acceptance testing
Life sciences manufacturers typically spend tens or hundreds of millions of dollars a year on new production equipment and facilities. Such capital investments are poised to rise sharply as companies quickly ramp up for production of Covid-19 related treatments alongside their existing products, as well as new treatments in the development pipeline. Further, the need to increase local manufacturing capacity to mitigate pandemic-related logistics disruptions will also drive an increased need to properly test and configure new equipment in new facilities.
Factory acceptance tests (FAT) of such equipment were traditionally done in-situ at the manufacturer by members of the customer’s staff. With today’s travel restrictions, manufacturers are moving to virtual factory acceptance tests using video links, virtual documentation, and even AR & VR technologies. These virtual factory acceptance tests will need to provide not only for rapid, seamless execution of the tests, but also for the associated workflows, audit, and verification procedures that ultimately assure regulatory compliance.
Remote configuration, validation and control of systems must also strike a fine balance between enabling robust remote access while keeping the network secure. This can be achieved through techniques such as network segmentation with multiple gated firewalls, threat detection bots, and multifactor authentication.
Driven in equal parts by the Covid pandemic-related travel restrictions and social distancing measures, we are seeing a significant uptake of virtual FAT processes that fully encompass collaboration, security, validation, and visual experience. We expect the trend toward adopting these efficient and cost-effective processes to continue after the pandemic eases.
Revised on-site protocols/work layouts
Those critical workers who are still on site must be protected from contaminating each other as they make the most efficient use of expensive equipment in labs and production facilities that were not designed to enable social distancing.
Thermal cameras can be used to flag employees with higher than normal temperatures, denying them entry or requiring further testing. For example, spaces can be reconfigured with, one-way aisles to allow social distancing. Cameras and facial recognition can alert managers to workers who are not properly distancing or not wearing a face mask. Bluetooth-enabled wristbands can buzz or flash when the wearer comes too close to another worker.
Bluetooth sensor-equipped soap dispensers, combined with motion-detectors in wristbands, can record if employees wash their hands with soap, and for the proper amount of time. Artificial intelligence and machine learning can be used to eliminate false positives for employees whose temperatures usually run high and to refine the accuracy and effectiveness of social distancing measures.
Localised, resilient supply chains
Pandemic-related production and distribution shutdowns have exposed the risk of global, “just-in-time” supply chains for the materials and components needed for life sciences products. Some countries have limited, or plan to limit, their exports of life sciences products or raw materials until their own needs are met.
Manufacturers are responding by reconfiguring supply chains to prioritise resiliency over efficiency and moving sourcing and production closer to the consumer. To enable this, manufacturers will need to move from centrally controlled procurement to giving site managers more visibility into and control over their immediate supply chains. They must also streamline the identification, selection, and validation of new suppliers to prevent supply disruptions. Qualifying such suppliers in the research and development stage can reduce delays when sudden shifts in production are required.
In the short- and medium term, digital technologies ranging from thermal cameras to wearable location monitors can help assure proper social distancing. Videoconferencing and AR/VR can minimise the number of employees who must be on-site for everything from equipment acceptance testing to the auditing of manufacturing processes.
In the long run, life sciences companies should speed the adoption of IOT and even platforms such as MES that enable full digitisation of the manufacturing process. By incorporating new technologies and work practices into their manufacturing plans, companies can run at full capacity while protecting their workforce and operating efficiently. These short-term investments pave the way for greater digitisations and prepare for any future pandemic disruptions.