Process Solutions
Innovative and sustainable process solutions for pharma, biopharma and biotech industries
Pharma and biopharma applications demand that high purity and process technologies evolve to keep pace with a changing drug manufacturing landscape.
Our experienced design, engineering, and automation teams have client-side experience and work closely with you to customise a sustainable solution that optimises your processes and delivers sterile integrity.
DESIGN & QUALITY COMPLIANCE STANDARDS
Vessel Design
- ASME BPE 2016 for vessel and piping manufacturing
- ASME Section VIII, Div. 1 for pressure vessel manufacturing
Process Design
- US FDA 21 CFR 177.2600 for gaskets and O-rings
- ASME BPE 2016 for vessel and piping manufacturing
Automation Design
- US FDA 21 CFR Parts 11 for Electronic records and electronic signatures.
- GAMP for Validation of Automated System
- GAMP 5 for a risk-based approach to compliant GxP Computerized Systems
Electrical Design
- IEC 60529 standards for panel enclosure protection
- EN/IEC-60204 and UL 508 for electrical work
- CE Marking Compliance Testing and Certification