This Confidential employer is a specialty pharmaceutical company focused on the clinical and commercial development of new products to address the needs of acute care practitioners and their patients. Confidential is driven by a dynamic workforce committed to optimizing patient care and satisfaction in the acute care setting, with a special focus on improving outcomes in postsurgical pain management.
In their scope of work, they provide non-opioid pain management and regenerative health solutions for healthcare practitioners and their patients in the United States. In 2012, they successfully launched a Product, which was the first and only DepoFoam-based local analgesic. Broadly indicated for administration into the surgical site to produce postsurgical analgesia in a variety of surgeries where infiltration is appropriate, this product provides long-lasting pain control that can reduce opioid requirements without the need for catheters or pumps.
This project included renovation of the first and second floor in this confidential space to support a new 200L cGMP manufacturing suite. This space allowed them to expand
production output by 200%. The key challenge to the project was how to fit an immense amount of equipment in a very small area. The 2-story site was rethought to include a mezzanine level, essentially creating 3-stories to support the manufacturing process. BIM coordination played an essential role in ensuring detailed routing and access for MEP and process systems across numerous trades, vendors, and design-build teams. Multiple construction phases were required to deliver this project while maintaining live manufacturing in other parts of the facility.
While small in footprint, at less than 20,000 square feet, this project was large in complex systems and scope. The manufacturing process system included over 30 prefabricated skids and 17 vessels (up to 5000L), with over 500 instruments and 800 control valves provided integrated automation. Over 20 plant and process utilities were required including solvent farms, pure water systems, process air and gases, clean steam, process chilled water, and more. Waste treatment systems included PH neutralization skids, IPA waste treatment, and a methylene chloride abatement system for stripping and cryogenic solvent processing. The site included three control systems – Building Management System, Utility Controls Systems, and Manufacturing Controls System, all of which was commissioned to ensure seamless integration.
GMC Commissioning provided commissioning and qualification of all systems on this project. A team of 8 commissioning professionals supported their internal team in delivering this highly complex facility. We executed around 150 commissioning protocols, which were leveraged to support equipment qualification. Commissioning test execution uncovered over 550 issues throughout the project which were tracked to resolution.