The Future of Multi-Product Facility and Equipment Design
Many contract development and manufacturing organizations (CDMOs) serve a variety of clients through multi-product facilities, which can carry the risk of cross-contamination. As CDMOs aim to consistently deliver safe and effective products, they can reduce or even eliminate this risk with innovative facility and equipment design.
Leaders from SKAN and Bausch + Ströbel recently joined Steve Nole, Vice President of Operations at Grand River Aseptic Manufacturing (“GRAM”), for a Contract Pharma webinar where they examined what it takes to have a safe and successful multi-product facility. View the guide:
Product Segregation vs. Multi-Product Acceptance: Facility and Equipment Design Solutions That Meet The Challenge
Key takeaways:
Flexibility has become the key to success in today’s pharmaceutical manufacturing world.
- Supporting multiple products from various customers requires robust, repeatable, and validated processes. GRAM will be using the VarioSys® modular production system and a second, duplicate fill line to stay agile while preserving the aseptic process. This technology allows for easy scale up to larger batch sizes and keeps GRAM at the forefront of technology.
Robust EHS and cross-contaminant risk analysis protocols for new product assessments are imperative.
- In addition to identifying gates for potential cross-contamination and ensuring procedural and engineering controls, manufacturing facilities should be designed to further minimize the risk of cross-contamination. GRAM’s new large-scale fill/finish facility was designed with product integrity top-of-mind – it incorporates unidirectional personnel and product flows, bag-in and bag-out filtration systems, and single-use disposable technologies.
Investing in best-in-class equipment and technology today is critical to future success.
- For this purpose, GRAM has opportune space in its newest facility and recently ordered its second Bausch+Ströbel fully integrated high-speed vial filler with SKAN isolator, along with a VarioSys production system.
It has always been important for us to partner with OEMs similarly aligned around quality-focused cultures, which is why GRAM chooses to work with Bausch+Ströbel and SKAN. Together, we are filling our new multi-product facility with equipment and technology that will safely and effectively support multiple products for years to come.