Hygienic Applications

ECE specializes in the codes and standards related to the hygienic process industries such as:

• Pharmaceutical
• Biotechnology
• Food & Beverage
• Personal care

Hygienic industries must consider numerous regulations and standards that have been developed and adopted over time.  Below are some of the most relevant codes and standards for which ECE has experience:

• ASME BPE – Bioprocessing Equipment
• ASME B31.3 – Process Piping
• ASME Boiler & Pressure Vessel Codes – Sections 5, 8 & 9
• AWS D18.2 – Guide to Weld Discoloration Levels
• ASTM – A269, A270, A380, ……
• FDA – Title 21 parts 210 & 211- Current Good Manufacturing Practices
• 3A – Sanitary Standards
• ISPE – Guideline and Baseline^® Documents

These standards, in combination with one another, provide requirements applicable to the design of components, equipment and critical systems.  Unlike most other codes of construction, these standards address unique aspects such as:

• Cleanability
• Dimensions and tolerances
• Surface finishes
• Tube welding
• Crevice free mechanical joining
• Seals related to hygienic installations

The United States FDA (Food and Drug Administration) recognizes these codes and guidance standards as part of the federal approval and regulation process.

Our experience with such stringent and special requirements reaches back over a decade. In particular, we have worked with major companies, involving tasks such as:

• Specifications – Critical System Engineering Requirements
• Engineering & Design – Process Systems, Skids and Modules
• In-Process Inspections – Component Installation and Hygienic Welding
• Certification– Material Traceability and Welder Qualification
• Factory Approval Tests – As-Built, Performance Testing
• Documentation– Engineering and Construction Quality Manuals

We work with leading organizations during the design, manufacturing, inspection, and approval phases of hygienic process systems and plant engineering projects.