The exacting production requirements for Bio/Pharma processing equipment systems present the most rigorous manufacturing challenges of any industry. Here’s how Lee Industries meets those challenges for the wide variety of production vessels required for batch formulation, mixing, fermentation and holding Bio/Pharma products.
Multiple vessel penetrations:
Bio/Pharma vessel designs often require many different attachments that penetrate the body of the vessel to allow for monitoring, measurement, sampling, agitation and other specialized process requirements. Since each of these penetrations may create individual hot and cold spots on the vessel’s surface; special precautions must be taken during the layout and design stages to maintain the vessel’s heating and cooling performance requirements. In addition, during fabrication, special skill is required to prevent heat warpage to the vessel surface as fittings and attachments for these openings are welded in close proximity to each other.
Ultra-high surface finish requirements:
Vessels for Bio/Pharma processing applications often require ultra-fine surface finishes. Lee’s in-house polishing capabilities provide surface finishes of less than 6 Ra average for mechanical finishing and 12 Ra maximum for electropolishing, to help you meet the most demanding surface finishing requirements. To address these and many other complex requirements the Lee Industries team has a long track record in meeting the most challenging design, engineering and fabrication requirements for Bio/Pharma processing.
Validation and Quality Assurance:
To meet your project’s stringent validation and QA requirements for Bio/Pharma applications, Lee Industries holds ISO, ASME, European PED, CE, Canadian and Singapore pressure vessel and manufacturing certifications. Before vessel production begins, source materials are inspected upon receipt with our Positive Material Identification (PMI) gun for non-destructive verification of chemical alloy composition of stainless steels and other metals used in production. Lee Industries performs routine vendor audits to verify ongoing quality for materials and components used in the manufacture of its vessels. During vessel fabrication, welds are carefully inspected throughout the project to verify weld integrity. Other tests, such as comprehensive dimensional checks, surface measurements and hydrostatic testing, are performed throughout the vessel fabrication stage.
For Bio/Pharma vessel projects, your company can make use of our offsite inspection facility in Tipton, PA, where vessels can be moved to provide for sprayball tests and additional extensive performance testing by your company’s QA, validation and inspection teams.
In addition to the required international, industry and ASME pressure vessel certifications, Lee Industries implements a seven-point internal inspection process prior to releasing every vessel for shipment. Here, every design and production team member involved in a vessel project, performs their own rigorous independent inspection on each production vessel before it ships from our facility.
Installation, Start-Up and Commissioning:
Proper installation and start-up of complex vessels for Bio/Pharma applications is critical to prevent installation damage and to ensure safe operation compliant with your company’s processing requirements. To assist you at this stage, our ASME-certified field service crew is available to travel to any location in the U.S. or internationally to provide installation supervision and start-up assistance for your new processing vessel.
To learn more about vessel and tank design for demanding Bio/Pharma processing applications, download our Guide to Bio/Pharma Engineering Services.
