In late August 2022, Grand River Aseptic Manufacturing (“GRAM”), needed commercial-scale, ultra-low-temperature capacity units at -50°C delivered in-house immediately to store forthcoming raw materials. A typical timeline for commercial-scale cold-capacity solutions can run months at a time, which would not meet GRAM’s needs. GRAM is a leading parental contract and development manufacturing organization that meets clinical and commercial fill-and-finish needs.
Units were needed to store vaccines for a potential fast-growing disease threat that required very rapid operational readiness. While GRAM had existing ultra-low temperature cold-wall freezers rated for -80°C, the existing freezers could not meet uniformity requirements at -50°C.
Further complicating the situation, the available space for the new freezers was limited, so the storage solution would require substantial density in a smaller-than-usual footprint. Lastly, due to the value of the stored product, the solution would need to offer operational redundancy.
GRAM also wanted a solution that would offer integrated redundancy so they could avoid the extra expense and footprint needed to keep just-in-case back-up freezers running. GRAM reached out to FARRAR™ to help them meet the challenge. FARRAR offers walk-in and reach-in ultra low temperature solutions for manufacturing, freezing, and storage of medicines, vaccines, and other life science products.
Both companies joined forces to execute within an extremely aggressive, six-week timeframe. After an initial phone call onAugust 24, the two organizations worked to finalize a purchase order before meeting for the first time in person on August 31.
During their initial meetings, the teams firmed up all project details, including freezer logistics, timeline, and implementation.
Based on their needs and discussion with FARRAR, GRAM selected three 190-cubicUltra Low Chamber (ULC) units which provide multiple benefits:
FARRAR was able to support this delivery schedule due to the modular design and innovative project delivery of the manufacturing and service staff.
The GRAM team prepared to receive the freezers by lining up riggers that would lift them directly into the second story of their facility. Having pre-determined specific shelf locations for the three freezers, the team then brought electrical power to the locations. They also ensured that Environmental Monitoring System cabling and sensors were at-the-ready to terminate into the equipment to allow quick equipment power-up and to start cooling down to set point immediately.
The units were shipped on September 9, and the installation team started freezer set-up on September 12. FARRAR supported GRAM with expedited installation qualification/operational qualification (IQOQ) documentation so that immediately following start-up and commissioning, GRAM was able to execute IQ/OQ validation to ensure compliance with regulatory requirements and industry standards.
The GRAM/FARRAR cross-company project team quickly established trust and developed a cadence that enabled them to smoothly execute a typically long-cycle delivery quickly, safely, and consistently to meet GRAM’s needs for quality and performance.
GRAM can now maintain required raw materials at a precise -50°C while counting on fast-temperature recovery from door opening in its sustainable, small-footprint solutions.
Additionally, GRAM deploys 2N redundancy on each chamber, as opposed to running an empty spare. GRAM started storing product storage on Sept. 19. Counting back from the original phone call, storage began 26 calendar days or 18 business days after the call (including a national holiday).
“GRAM’s core values of collaboration and customer service support our team in making decisions swiftly,” said Matthew Van Gessel, Senior Manager of Capital Projects and Expansion at GRAM. “In a matter of weeks, the FARRAR and GRAM teams went from placing the order to installation, qualification, release, and use of the -50°C freezers. The strength in partnership and culmination of responsive communication and coordination between the two teams resulted in the expedited outcome.”
“The entire FARRAR team takes pride in supporting a pressing human health issue by delivering these units at such an unprecedented pace, especially given the supply-chain challenges of the past year,” said Holly Paeper, President, LifeScience Solutions and FARRAR.