Grand River Aseptic Manufacturing, Inc. (“GRAM”) expands disposable technology capabilities at its FDA-approved manufacturing facility in Grand Rapids, Michigan.
Over the past year, GRAM has added numerous capabilities to improve the overall service provided to clients, the latest of which is disposable technology. Disposable technology (also known as ‘Single-Use Systems (SUS)’) is one of the most important and valuable added capabilities due to its complementary benefits to both GRAM and the client.
The benefit of disposable technology to the client is threefold: (1) cost savings; (2) time savings; and (3) improved safety and quality standards associated with SUS. As compared to the stainless steel system alternatives, process development timelines for disposable technology are greatly reduced.
Additionally, there is greater flexibility in process design process which contributes to an overall lower capital cost. Also, by nature of being an SUS, client cross-contamination risks have been greatly mitigated.
By utilizing disposable technology, GRAM is able to benefit from efficiency gains by reducing processing time, cleaning time, and prep time. Manufacturing downtime is also reduced due to the elimination of validation activities that come with the cleaning process. Eliminating the cleaning processes and validation activities also allows GRAM to realize costs savings associated with water-for-injection.
Steve Nole, GRAM’s Director of Manufacturing, stated, “We’re excited to offer expanded disposable technology capabilities. This will enable us to respond more quickly to client needs and ultimately reduce their costs.”