Hygienic Equipment & Fabrication Validation
The Pharmaceutical, Biotechnology, Food & Beverage and Personal Care product manufacturers are predominately regulated and therefore must comply with national and international laws, regulations codes, standards and alike.
Certification for manufacturers within the Hygienic industries ultimately translates into a license to manufacture. The steps to achieve a license to manufacture requires Qualification and Commissioning activities upon which Validation is built. Validation challenges the entire “System” for compliance according to good engineering practices, engineering specifications, process integrity and product quality. Using ASME BPE standards is critical for component and system validation according to cGMP and FDA requirements.
ECE applies ASME BPE and provides validation services for:
- Master Planning
- System and Equipment Impact Assessment
- Risk Assessments
- Enhanced Design Reviews (EDR) \ Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification ( PQ)
Vendor Qualification Requirements
Manufacturers rely on contractors and suppliers to meet project specifications. Increasingly vendors have the ability to contribute according to project requirements, but tend to minimize their contribution to the point they don’t comply with the requirements. Moreover, the project needs the resources to ensure the project requirements and in particular vendor deliverables are qualified before or upon receipt. ASME BPE standards is a key benchmark for vendor qualification.
ECE provides validation services for:
- Vendor Auditing / Capability & QA System Assessment
- Weld Procedure and Welder Qualification
- Documentation Qualification
- Factory and Site Acceptance