Hygienic Process System Design and Fabrication for Multinational Pharmaceutical Company

EPIC designed and fabricated ten sanitary process systems for a multinational pharmaceutical company that recently announced a $2-billion expansion of their medicine-manufacturing operations. EPIC provided design-build services for two solvent recovery hygienic process systems and eight mixing sanitary process systems. All sanitary and hygienic process systems were designed at EPIC and subsequently fabricated, inspected and Factory Acceptance Tested (FAT) in EPIC’s isolated sanitary fabrication shop.

CLIENT: A multinational pharmaceutical company
INDUSTRY: Diabetes and Obesity Medicines

CORE CONSIDERATIONS

• ASME BPE – EPIC’s in-house quality assurance team ensured that each hygienic process system was designed and fabricated in accordance with ASME BPE standards. EPIC’s process and mechanical team collaborated with the customer to develop welding procedure specifications (WPS) that exceeded the requirements set forth by the American Society of Mechanical Engineers. EPIC’s quality assurance team also provided welder performance qualification (WPQ) records for every craftsman who worked on the project.
• Materials of construction – All materials of construction were verified using Material Tracking Reports (MTR) and Certificates of Conformance (COC).
• Traceability – Qualified craftsmen maintained stringent documentation while receiving and implementing materials of construction, recording heat numbers at every phase and maintaining up-to-date weld maps throughout the entirety of the project.
• Inspection – 100% of hygienic welds were visually inspected by EPIC’s CWI weld inspectors to ensure that they met BPE requirements. When required, the interior welds were inspected using a borescope.
• Physical Design Restrictions – Because of the tight space constraints required by the customer, meeting the requirements for system maintainability, accessibility and Good Manufacturing Practices (GMP) was a challenge. EPIC’s engineers solved this challenge by conducting continuous onboard reviews of 3D models with the client personnel to ensure that the modular skid design fit within production plant space constraints.

KEY SYSTEM FEATURES

All sanitary and hygienic process systems were pre-assembled in EPIC’s isolated sanitary fabrication shop.

All 10 skids were designed modularly, making them easy to disassemble after offsite FAT and reassemble before onsite startup and commissioning.

The 2-skid solvent recovery hygienic process system included three 40-cubic-meter tanks and two 30-cubic meter tanks.

BPE welding requirements were applied to the SCH 10 piping systems for the eight mixing sanitary process systems.

AN EPIC IMPACT

EPIC was able to install and commission the hygienic process systems fast and efficiently. The modular design-build construction methods and offsite Factory Acceptance Testing (FAT) condensed the timeline compared to traditional stick-build construction methods.

Project management was simplified by designating a single point of contact for the customer. EPIC’s project management team had industry-specific experience that allowed them to oversee EPIC’s in-house design, fabrication and quality assurance teams. This was important to ensure the process was kept sanitary and on schedule.

With the services EPIC provided, this customer was able to safeguard the production and availability of important diabetes and obesity medicines by doubling the company’s plant operations.

Contact EPIC to speak with an engineer about your hygienic process system project or call 314-272-4149.