With the overall number of patients rising, diabetes is on its way to becoming a widespread disease. As a result, the need for insulin is on the increase. The Brazilian biotech start-up Biomm is dedicated to fighting the disease to improve many peoples’ lives. Biomm has now built a plant in Nova Lima/ Brazil to produce insulin compounds and to fill fluid solutions and suspensions into vials and cartridges. The plant is set to go into operation in 2018.
From the start, Biomm had a clear idea of what it wanted from its partner to implement the filling line: “Current regulatory requirements call for a robust and reliable project. To be successful in a highly competitive environment, we need to work with the latest technologies,” explained Francisco Freitas, CEO of Biomm.
Convincing overall concept
Biomm eventually decided on Bosch because of its convincing turn-key solution. Bosch was able to both deliver lines for vials and cartridges and also establish efficient interface processes. The lines have a generation unit for purified water, which is distilled to water for injection (WFI) in the next step. A pure steam generator, sterilization in place (SIP) and cleaning in place (CIP) modules as well as preparation systems are also included. Each line consists of an RRU cleaning machine and an HQL sterilization tunnel. The uni-directional airflow system ensures aseptic filling of the vials in the FLC 3100. In the next step, the vials are closed with rubber stoppers and sealed with a crimp cap. The cartridges are closed on an MLD immediately after filling.
The integrated solution not only made project management easy for Biomm, but also helped to stick to the tight schedule for market entry. “The overall project coordination, together with the experience and the understanding of our specific needs were key to this success,” Freitas said.
Dr. Frank Scholl
Head of Project Management Integrated Solutions Pharma
+49 7951 402-741