BioPharm International - November 2022

BioPharm International - November 2022

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www.biopharminternational.com Manufacturing and Facilities 2022 eBook BioPharm International ® 7 AutomAtion securely. Much too often, technology and automation solutions are planned or even get implemented that do not meet strict cybersecurity standards that life science manufacturers must maintain and become a liability that must be corrected. Workstreams must be kicked off to determine methods for secure storage of the data, and a retention policy must be developed. Keeping cybersecurity and data integrity a priority during early design collaboration will help achieve a more secure outcome for the critical data being gen- erated and stored. The other important consideration for an early au- tomation design conversation is extensibility. If plan- ning for any advancement in the future, how the facil- ity is set up today could greatly impact the outcome. An attempt to automate or digitize a process later without the infrastructure to do so will be costly or could even become a lost cause. Being cognizant of the technical requirements for future automation or dig- itization plans helps to prevent this from happening. That is why engineering and automation staff working together as a team early in the project can enable the facility to extend and grow as technology permits. Collaboration as a team can also help confirm the right developments are being made to support the dig- ital transformation journey and increase operational value. Answers to the following questions can help guide decision-making so that the right steps are being taken at the right time for a business: • What benefits will be received (i.e., useable data, process improvements, etc.)? • What level of automation can help improve qual- ity or reduce safety concerns? • Does it save money? Without this input, it is possible to add technology where it is not needed or when it does not provide sig- nificant cost or efficiency savings. The earlier these conversations happen, the bet- ter the chance exists of receiving buy-ins from other key decision-ma kers and ma k ing t he right deci- sion sooner. Early buy-ins usually result in savings for the design, as technology and equipment can be caref ully planned for, the proper resources a llo- cated, and major infrastructure changes in the future avoided. Considering the data integrity and extensibil- ity of the platform early in the lifecycle of the project can help maximize production at the facility and en- sure there are no surprises or roadblocks when it comes to advancements in the future. The collaboration should not stop After the successful commissioning and startup of a facility, when the right people are involved early and all design and automation requirements are taken into consideration, maintaining strong relationships can offer even greater benefits. To ensure the facility is evolving to meet industry demands, a collabora- tion between EPCs, automation vendors, and original equipment manufacturers during the project should not stop after startup. Keeping the communication lines open for the implementation of new ideas and sharing of solutions allows for more efficient tech- nology adoption when the time is right to implement a new feature or install a new component. Staying aligned also means that standards can be regularly reviewed, and adjustments made to verify they are meeting current needs and are prepared to meet fu- ture business objectives. This will ensure that effort is not being spent to support something that is no longer relevant—further saving time and money. With the life sciences industry changing rapidly and increasing pressures for efficiency, manufacturers need to view the automation design process as a con- tinuous collaboration for the entire lifecycle of their equipment and facility. Why now? As in many industries, the life sciences industry is en- tering a new era of digital transformation. Every new single-use facility is being built to be more advanced than the last, with the implementation of new equip- ment, components, and devices with higher levels of automation and the generation of more process data. These new smart facilities are creating a push for older facilities to quickly adopt the latest technologies and automation to increase their operational value. As mentioned previously, single-use advancements are migrating away from their former manual state and can now be highly automated to optimize production and generate a wealth of insightful data. These new au- tomation advancements need to be a key consideration at the start of the project and strategically planned for the future implementation into the facility to more ef- ficiently realize a facility's potential. From design to qualification, a close automation design collaboration between EPCs and automation suppliers leads to bet- ter informed and data-driven decision-making for the launch of intelligent single-use facilities. Whether introducing automation into existing operations to further advance a digital transformation journey or embarking on a new single-use facility project, it is recommended to involve an integrated engineering and automation team who are ready to help identif y strategies to achieve the business needs. Maximize the facility's potential by involving your EPC and automation supplier early in your proj- ect discussions and by continuing this collaboration after the facility launch. By promoting collaboration during the planning and design phase of a single-use facility project, engineering and automation com- panies can achieve greater quality, operational, and financial efficiencies for their clients. ■

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