CLINICAL SUPPLIES MANUFACTURING FACILITY—BUILDING 115
- Project Overview
- Project Details
New Brunswick, New Jersey
TOTAL SQUARE FOOTAGE:
133,000 sq. ft.
2008 ISPE Category Winner in Equipment Innovation
Torcon was the Construction Manager for a two-phase renovation and construction effort for Bristol-Myers Squibb that created a state-of-the-art clinical manufacturing center at the BMS New Brunswick campus. The facility produces both oral solid dosage and parenteral drugs to be used in clinical trails.
The project required the gut renovation and fit-up of an existing building, including all new building services, utilities and equipment. In its initial phase, Torcon fit-out a 93,000 square foot space for clinical supplies operations (CSO), in which 30,000 square feet is process areas. The facility was designed for the manufacture of oral solid dosage batches up to 400Kg and parenteral liquid fill batches up to 250L. The flexible facility features the ability to perform multi-product clinical scale manufacturing to handle solvent-based and potent compound operations while adhering to cGMP. The facility supports parenteral and oral dosage formulation and finishing operations, generating materials for First-in-Human, phase II and Phase III clinical studies. To meet containment and regulatory GMP requirements, the facility was segregated into three manufacturing zones: Parenteral, OSD Band 1–4, and OSB Band 5. Areas designated as Band 5 require isolator technology, remote operations, wash-in-place/clean-in-place systems, and automation.
The CSO Parenterals area is equipped with an isolated vial filling line for both sterility and containment reasons. The line is the most flexible continuous barrier line ever built. All formulations processed in the isolated filling line are produced in a formulation isolator located in an adjacent room that includes the same solvent and potent handling features.
Each Band 5 processing suite has separate transition areas dedicated for people or for materials and equipment. The two OSD processing suites support a variety of contained OSD operations such as wet and dry granulation, bin tumble blending, compression, encapsulation, tray drying and dry milling.
Access to the OSD spaces is controlled through airlocks, maintaining cGMP zone integrity. For the Band 5 OSD suites, additional containment was achieved by utilizing one-way flow of personnel into and out of the suites. In the Parenteral space, access is controlled through one-way airlocks, maintaining cGMP zone integrity and containment.
The second phase of renovation, which followed immediately after phase one construction completion, added long-term stability (LTS) batch operations in support of BMS’ oral solid dosage manufacturing of potent compounds. The space encompasses three process rooms with support areas: bin blender, aqueous coating and spray drying. Each room includes a floor scale and marble tables for portable balances, and is integrated with the site Delta V control system.
A product technology center (PTC) was also added in this phase of the project to perform both process development and scale-up for batches in the range of 20Kg to 100Kg. Although the operations performed within the PTC area are characterized as non-GMP activities, the qualification, maintenance and operation strategies provide sufficient support for future changeover to GMP operations. The PTC facility supports OSD unit operations for potent compounds having exposure control band 4. The process suites are designed to carry out the following operations: new technologies (hot melt extrusion, pelletizing, nanomilling); capsule filling, roller compaction, tablet compression, weighing and wash operations and high shear wet procession, blending, tablet coating and an in-process laboratory.
The completed facility has a new chiller plant, as well as all new process utilities, a new WFI and clean steam generator, clean-in-place systems and a water neutralization and deactivation system.
Torcon provided commissioning services for both phases of this project.
BMS’s Building 115 was recognized by ISPE on its annual Facility of the Year competition. The project was one of four category winners in the international program.