Project Feature: Miltenyi Biotec
Updated: Sep 9, 2021
Saving time, increasing value and maintaining high quality
Value today is based on creativity and innovation - using systems, technologies, and processes in new ways to provide services that benefit our customers. Value creation is the foundation of our business. By solving unique problems, we can save clients time and money.
For more than 30 years, Miltenyi Biotec has played an important role in the design, development, manufacture, and integration of products that empower the advancement of biomedical research and enable cell and gene therapy. Miltenyi Biotec is a global biotechnology company headquartered in Germany. The company is a provider of products and services that support scientists, clinical researchers, and physicians across basic research, translational research, and clinical applications. The company offers solutions covering techniques of sample preparation, cell separation, cell sorting, flow cytometry, cell culture, molecular analysis, clinical applications and small animal imaging.
The 90,000 sq.ft. Clopper Road renovation project expanded Miltenyi cGMP manufacturing capabilities in Gaithersburg, MD. The project included renovations of the north building, warehouse, and a new central plant building. All new mechanical, electrical, plumbing and process systems were installed as part of the project.
To provide value to Miltenyi and the project, GMC Cx implemented a risk-based commissioning and qualification (C&Q) effort to expedite schedule while maintaining quality procedures. Commissioning protocols for cGMP systems were leveraged for installation and operational qualification (IOQ). Additionally, GMC Cx provided full qualification for cold storage systems including temperature mapping studies.
Our expertise in this delivery model allowed us to save the project personnel hours and schedule. We have extensive experience in GMP-regulated environments, good documentation practices (GDP) and our experienced subject matter experts (SMEs) ensures good engineering practices (GEPs) and quality construction. Our focus on product and process risks to product quality will yield long-term operational cost saving benefits and lifecycle utility, well beyond the original capital expenditure.
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