Steve Nole, VP of Operations, Grand River Aseptic Manufacturing01.27.21
As the COVID-19 pandemic drives pharmaceutical companies to increase the resiliency of their supply chains, pharmaceutical manufacturers are looking to multi-product facilities to meet in-creased demand.
While utilizing multi-product facilities can lead to cost savings and reduced timelines, it can also present several challenges—the first and foremost being the risk of cross-contamination. While contamination concerns have long been present, the growing trend of outsourcing has exacerbated the need for better controls. In addition, many of these facilities are retrofitted and outdated, which inhibit flexibility and adaptability and make it difficult to establish one-way product flows. As the pharmaceutical industry is under extreme pressure to produce life-saving medicines quickly and cheaply, it can also be a pain point to preserve the aseptic process under expedited time-lines.
For the pharmaceutical industry to overcome these challenges—and to safeguard product integrity and safety now and in the future—an overarching solution is to make investments in innovative facility and equipment design.
When it comes to facilities, the greatest return on investment for pharmaceutical manufacturers comes from specifically designing state-of-the-art facilities to support multiple products, processes and customers. Retrofitting existing facilities may be the more common, faster and less expensive route, but what manufacturers save in time and money, they ultimately sacrifice in flexibility and adaptability. To ensure product containment, newer facilities should be designed with the appropriate people and product flows in mind.
The forward-thinking design of equipment and technology is also essential to product containment and future success of multi-product facilities. Modular production systems—and critical components like unidirectional personnel and product flows, bag-in and bag-out filtration systems and single-use disposable technologies—are quickly becoming essential because they allow for the benefits of segregation without the expense of separate fill lines. Designed to grow with the pharmaceutical market and tailored to the meet the unique needs of current and prospective clients, these systems further reduce timelines and costs while maximizing flexibility.
The ability for manufacturers to offer advanced digital capabilities and additional engineering controls will be critical to success as the expectation for product containment and segregation increases. In addition to process reliability and efficiency, advanced digital solutions will be required for monitoring as well as tracking products and processes. Regularly conducted risk analyses that identify potential cross-contamination gates also ensure that procedural and engineering controls are operating efficiently and effectively mitigating risks.
As a contract development and manufacturing organization (CDMO) supporting key players in the pharmaceutical industry, Grand River Aseptic Manufacturing (GRAM) has prepared for the future by implementing this guidance. Our new multi-product, large-scale fill/finish facility in Grand Rapids, Michigan was designed from the ground up with safety, quality and flexibility top of mind. By investing in best-in-class equipment supported by the latest technology and designing a facility with superior environmental, health and safety (EHS), engineering and cross-contamination controls, GRAM can support the varied needs of current and prospective clients now and in the future.
As the entire pharmaceutical manufacturing industry continues to shoulder immense pressure to be more cost-effective and reduce timelines for life-saving medicines, dynamic multi-product facility and equipment design will only grow in prominence. Flexible equipment supported by modern facility design along with proven processes and controls reduce risk and can ultimately help eliminate the threat of cross-contamination. With demand growing every day, pharmaceutical companies should take decisive action today to better prepare for tomorrow by investing significant capital in modernization of facility and equipment design.
While utilizing multi-product facilities can lead to cost savings and reduced timelines, it can also present several challenges—the first and foremost being the risk of cross-contamination. While contamination concerns have long been present, the growing trend of outsourcing has exacerbated the need for better controls. In addition, many of these facilities are retrofitted and outdated, which inhibit flexibility and adaptability and make it difficult to establish one-way product flows. As the pharmaceutical industry is under extreme pressure to produce life-saving medicines quickly and cheaply, it can also be a pain point to preserve the aseptic process under expedited time-lines.
For the pharmaceutical industry to overcome these challenges—and to safeguard product integrity and safety now and in the future—an overarching solution is to make investments in innovative facility and equipment design.
When it comes to facilities, the greatest return on investment for pharmaceutical manufacturers comes from specifically designing state-of-the-art facilities to support multiple products, processes and customers. Retrofitting existing facilities may be the more common, faster and less expensive route, but what manufacturers save in time and money, they ultimately sacrifice in flexibility and adaptability. To ensure product containment, newer facilities should be designed with the appropriate people and product flows in mind.
The forward-thinking design of equipment and technology is also essential to product containment and future success of multi-product facilities. Modular production systems—and critical components like unidirectional personnel and product flows, bag-in and bag-out filtration systems and single-use disposable technologies—are quickly becoming essential because they allow for the benefits of segregation without the expense of separate fill lines. Designed to grow with the pharmaceutical market and tailored to the meet the unique needs of current and prospective clients, these systems further reduce timelines and costs while maximizing flexibility.
The ability for manufacturers to offer advanced digital capabilities and additional engineering controls will be critical to success as the expectation for product containment and segregation increases. In addition to process reliability and efficiency, advanced digital solutions will be required for monitoring as well as tracking products and processes. Regularly conducted risk analyses that identify potential cross-contamination gates also ensure that procedural and engineering controls are operating efficiently and effectively mitigating risks.
As a contract development and manufacturing organization (CDMO) supporting key players in the pharmaceutical industry, Grand River Aseptic Manufacturing (GRAM) has prepared for the future by implementing this guidance. Our new multi-product, large-scale fill/finish facility in Grand Rapids, Michigan was designed from the ground up with safety, quality and flexibility top of mind. By investing in best-in-class equipment supported by the latest technology and designing a facility with superior environmental, health and safety (EHS), engineering and cross-contamination controls, GRAM can support the varied needs of current and prospective clients now and in the future.
As the entire pharmaceutical manufacturing industry continues to shoulder immense pressure to be more cost-effective and reduce timelines for life-saving medicines, dynamic multi-product facility and equipment design will only grow in prominence. Flexible equipment supported by modern facility design along with proven processes and controls reduce risk and can ultimately help eliminate the threat of cross-contamination. With demand growing every day, pharmaceutical companies should take decisive action today to better prepare for tomorrow by investing significant capital in modernization of facility and equipment design.
