Sanitary Grade Process System Design for Pharmaceutical Company

EPIC designed and fabricated two hygienic solvent recovery systems and eight sanitary mixing systems for a global pharmaceutical company. Project success was achieved through timely delivery, efficient processes, industry compliance, and a commitment to the client’s expansion goals.

Hygienic Process System Design



  • Industry: Pharmaceuticals 
  • Company Size: 40,000 employees, $25BB BB revenue  
  • Location: North Carolina, USA 
  • Customer Use Case: Hygienic Batch Mixing 



A multinational pharmaceutical company embarked on a $2 billion expansion of its medicine manufacturing operations, requiring the design and fabrication of two solvent recovery hygienic process systems and eight mixing sanitary process systems in a compressed timeline. The main objective of the project included the adherence to ASME BPE guidelines for hygienic standards and maintaining the highest quality control to ensure that process equipment complied with sanitary production requirements. Additionally, ensuring accessibility for maintenance and adhering to Good Manufacturing Practices (GMP) were paramount, given the constraints of a small footprint of the production plant 



EPIC Systems took on the challenge by designing and fabricating the required systems using modular tactics. The two-skid solvent recovery system and eight mixing sanitary process systems were constructed with modular designs, and continuous onboard reviews of 3D models were conducted with the client to ensure the fit within production plant space constraints. This modular approach facilitated easy disassembly for offsite Factory Acceptance Testing (FAT) and quick reassembly before onsite startup and commissioning, saving considerable time compared to traditional stick build methods. 

To streamline communication, EPIC assigned a dedicated Project Manager as the overall project lead. The project team, leveraging industry-specific experience, oversaw in-house design, fabrication, and quality assurance teams to ensure compliance with sanitation requirements without compromising the tight timeline.  

EPIC implemented ASME BPE standards in the design and fabrication of the hygienic process systems. All 10 skids were fabricated, inspected, and pre-assembled in EPIC’s isolated sanitary fabrication shop. EPIC’s quality assurance team ensured compliance through continuous inspections, including visual inspections of hygienic welds using borescopes. 

The Project Manager and mechanical engineering team collaborated with the customer to develop welding procedure specifications (WPS) that exceeded ASME BPE standards. Rigorous material verification was done using Material Tracking Reports (MTR) and Certificates of Conformance (COC). EPIC provided welder performance qualification (WPQ) records for every craftsperson involved in the project, maintaining stringent documentation throughout the construction phases. 



Time-Saving Solution and Delivery: The modular tactics employed by EPIC proved to be a time-saving solution, streamlining the design, fabrication, and assembly processes. This approach met the client’s goals and contributed to the client’s success by adhering to the accelerated deadline. 

Stringent Industry Standards: EPIC’s modular approach not only met but exceeded stringent industry standards, ensuring that the hygienic process systems complied with ASME BPE guidelines and other relevant regulations. 

Efficient Installation and Commissioning: With a focus on efficiency, EPIC seamlessly installed and commissioned the skids after thorough quality testing, minimizing downtime and ensuring a quick transition to operational status. 

Expanded Production Capability: The delivered sanitary-grade systems enabled the client to significantly expand its production capability, providing a tangible boost to their operational capacity and overall growth. 

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EPIC Systems is a multidisciplinary engineering integrator specialized in industrial automation for process manufacturers. We deliver solutions in the following areas:

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