Project
Implementation of a service contract for the engineering and qualification of USP/DSP production equipment:
- Mobile tanks with options (agitation, regulation, double jacket, CIP, SIP)
- UF filtration SKID
- Chromatography SKID
- Chromatography column
- SKID Fermentation
Expertise
DSP equipment (chromatography, ultrafiltration)
Sheet metalwork/piping
Automation and instrumentation
Qualification
Challenges
- Quality : 5/5
- Cost : 2/5
- Deadlines : 3/5
- Security : 3/5
Services provided
- Definition of equipment URS with users
- Supplier consultation and alignment
- Validation of studies and manufacturing follow-up
- Commissioning FAT/SAT (Drafting and execution)
- Qualification (QC/QI/QO) of production equipment (Drafting and execution)
