ProFlow Partners with Pharmaceutical Contract Manufacturer to Help Ramp Up Production of Precursor Chemicals
A U.S.-based pharmaceutical contract manufacturer needed to increase production of precursor chemicals in one of its manufacturing facilities. The company turned to ProFlow for help, knowing that that this effort required a supplier with experience in the development of scaled-up fluid processing systems with complex characteristics.
As is often the case with pharmaceutical precursors, the chemicals were volatile and dangerous, needing to be handled safely and metered precisely to match the customer requirements. An added challenge was presented by the fact that there were significant space constraints where the system was to be housed, limiting the size of the installed skid.
ProFlow engineers worked with the customer to design the system, specify components and materials, and fabricate the finished system. Our experienced engineering staff teamed with our fabrications group (supported by the company’s extensive fabrication certifications) to tackle this project. Adding to the complexity of this project was the requirement to meter-in two aggressive chemicals at an accuracy of +/- 1%. The system also had to be built to cGMP requirements.
Additionally, since the customer required FDA approval, ProFlow provided the material certifications, calibration certificates, and surface finish certificates necessary to obtain that approval.
The System
The final system was designed and built to best meet the requirements of the application and included 316 polished stainless steel frames and Hastelloy C276 pumps and piping, along with other specialized pumps. The system was also equipped with the complex instrumentation and controls required to operate the system. All items were built to the requirements for an explosion-proof application.
Key components include:
- Polished Hastelloy tanks, ASME coded
- Magnetic drive Hastelloy gear pumps, with USP Class VI elastomers.
- 316SS polished positive displacement pumps
- Mass flow meters
- Ultrasonic level switches
- Gauge pressure transmitter with tantalum diaphragm seal built for sanitary applications
- Level and pressure transmitters