Case Study: Filling in the Gaps for a Pharmaceutical Retrofit
The Customer:
A global leader in the pharmaceutical manufacturing/life sciences industry
The Problem:
Through the purchase of a smaller company, the manufacturer acquired a new facility in the Midwestern United States. To reach ideal operating capacity, the building required Instrumentation & Control (I&C) to support its basic engineering design during a retrofit of the entire facility. This would allow the company to produce two distinct antibody products — each using one large and one small scale process train.
The Orise Solution:
Upon evaluating the problem, our team of expert engineers at Orise knew that a variety of elements would need to be implemented in the production facility. These included:
- Process Controls, Process Systems, and Utilities
- I&C design and procurement services
- Data Historian
- Reporting
- Commissioning & Qualification
- Panel Design
- Qualification Documentation
- Operations support
- Interface with engineering design firm and construction firm
We went to work at the location in the early spring and, along with the client, set an aggressive schedule and tight budget to get the project successfully completed. Our capability to achieve impressive goals in a limited time paired with our extensive experience in the biotech industry, access to specific technology platforms, and ability to meet tight monetary constraints to ensure the customer that we would provide outstanding results.
The Impact:
The work provided by Orise created outstanding results for the pharmaceutical giant. Above all else, the facility became a fully-functional pharmaceutical plant that still today:
- Meets FDA regulations
- Hosts a very impressive GMP controls architecture
- 3,500 I/O’s
- 3,175 Control Modules (CM)
- 414 Equipment Modules (EM)
- 772 Phases
- 200+ Recipe Components
- Significantly mitigates production risk
- Increases batch efficiency
- Optimizes raw material use
- Lowers overall operating costs
Orise provides a team of highly-skilled engineers for every client with whom we work. Our expert level of knowledge when it comes to pharmaceutical product batching is incredibly difficult to match and allows us the ability to give each and every customer outstanding results, even with limited time frames and budget constraints. Contact us today to get started on your next batch project.