Issue link: https://www.e-digitaleditions.com/i/1211868
www.biopharminternational.com February 2020 BioPharm International eBook 27 FOCUSING ON VALUE Dig ita li zat ion as a ter m has a broad spectrum and can take place within many different parts of a CDMO. While Industry 4.0 is pro- duction oriented, there are differ- ent digitalization projects that are not directly associated with the value chain, such as data analytics software in the field of R&D. It is important to segment the topic of digitalization into different groups to get a proper overview. For exam- ple, digitalization can be as sim- ple as replacing a paper book at a visual inspection workstation with a tablet. Staff members would enter their inspection findings directly into the enterprise resource plan- n i ng s y ste m u si ng t he t able t instead of documenting them in a paper book. The process could also be more complex, such as digitally design- ing formerly paper-based processes within a new software. For exam- ple, the transfer of measured data in a laboratory previously taking place in an analog manner could be connected to a digital process. The measuring equipment would automatically send the data to the software, which stores it and pro- cesses the data for downstream steps. Digitalization also covers new trends and technologies such a s mac h i ne lea r n i ng , a r t i f ic a l intelligence, blockchain, and big data. And while there is signifi- cant potential in these technol- ogies, it is best to use them only where they make the most sense. Projects should be chosen inde- pendently from their duration and complexity, focusing instead on whether the project will increase quality and efficiency and, thus, add value to the organization and all related partners, including cus- tomers and suppliers. CONCLUSION When it comes to digitalization, phar maceutical companies and CDMOs have a lot in common. A clear focus on projects that add value as well as managing organi- zational and technological change are only two examples. However, the high complexity due to the high process variety as well as the digitalization of processes while maintaining flexibility are specific challenges of a CDMO. Having the expertise necessary to deal with these challenges is crucial for a CDMO. Done right, digitalization has a positive impact on the qual- ity of products and processes of a CDMO, and a customer-centric and innovative approach maintains its flexibility. BP Partnerships for Outsourcing Outsourcing Considering digital tools for equipment maintenance Performing equipment maintenance to prevent breakdowns or unplanned process stops is an obvious best practice; how to know when to do that maintenance is not as simple. Preventive maintenance is the conventional pharmaceutical industry practice that involves setting a time-based maintenance schedule for a piece of equipment, typically using models based on experience and original equipment manufacturer (OEM) recommendations. Preventive maintenance schedules are usually set conservatively, to be short enough to have a low risk of failure. Digital tools are helpful in managing this routine and scheduled maintenance. "Many companies still rely on paper records to manage their manufacturing floors, including equipment maintenance activities. But in a high-paced and high-volume production environment, you simply can't be proactive when you operate on paper," suggests Matt Lowe, MasterControl's president of laboratories. "Digital preventive maintenance systems are the bare minimum in today's competitive manufacturing marketplace. The goal is to avoid missed or delayed maintenance tasks and keep equipment in good working condition," says Lowe. Some pharmaceutical manufacturing facilities run 24 hours a day, seven days a week, with two-week shutdowns twice a year for preventive checks, notes Jon Biagiotti, product marketing manager at Augury. This standard approach, however, may not be cost-effective or an optimal use of resources. "Preventive maintenance may be done too late, not addressing potential issues until the next scheduled check, so that it degrades to a more expensive fix. Or it may be done too early, when it isn't needed yet," he says. "The pharmaceutical community is showing great interest in predictive maintenance because the conservative nature of our applications results in frequent preventive maintenance. Preventive maintenance is not always needed and results in costly downtime," adds Pamela Docherty, industry manager at Siemens. Continuous monitoring and condition-based predictive maintenance, which predicts how an asset will perform in the future and tailors decisions for specific situations, offer the potential to improve efficiency and quality compared to time- based preventive maintenance. —Jennifer Markarian