In this article, Bentsi Algazi, Vice-President of Operations, and Anna Kalika-Rodin, Quality Manager, both of Sorrel Medical, discuss the process of developing and implementing in-house production facilities at Sorrel Medical, including cleanroom facilities.
The authors discuss the regulatory requirements involved, practical considerations of the design and construction, and the benefits the establishment of in-house facilities confers to Sorrel and its pharmaceutical partners.
Growing recognition of the need for patient-centric drug delivery devices, combined with the increasing prevalence of biologics and a general trend towards home care and self-administration, has led to greater demand for disposable and easy-to-use wearable injectors. As such, pharmaceutical manufacturers are increasingly investigating wearable drug delivery solutions as an option for launching new products to market, as well as for lifecycle management of combination products already in circulation.
Consequently, device manufacturers and technology vendors must align themselves with pharma’s evolving development needs – to deliver devices that meet pipeline expectations, while ensuring all the quality controls and necessary standards are maintained. With an understanding of the direction in which the industry is moving, Sorrel has established its own independent manufacturing and cleanroom facilities to accommodate scalable production of wearable drug delivery devices (Figure 1).
As demand from multiple customers increases, it is essential that Sorrel’s manufacturing capabilities can scaleup accordingly, while still maintaining a level of quality that meets the highest requirements throughout the production process. Customization and adaptable manufacturing capabilities allow for Sorrel to manufacture devices according to customer requirements, either in-house or outsourced to third-party providers.