25 Feb 2019

Regenerative Medicine

Location: Lexington, MA

This client in Waltham, MA is a clinical-stage company, focusing on the development of restorative cell therapies in the United States. The company offers a tissue implant product, which is in Phase III clinical trial to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee.





Project Scope –
PPT provided RODI equipment, install, start-up, sanitization and supported validation with project documentation and IQ/OQ development

Water Quality USP with WFI endotoxin limits
Pretreatment Carbon softening
RO Production 2,800 GPD
Membrane type BW4040
Recovery rate 70%
Reject Rate 98%
Storage Tank 250 Gallons
Distribution Flowrate 30 GPM
UI oxidation 185nm
Final Filtration 1 µ
Deionization Type Electrodeionization
Post EDI filtration Ultrafiltration
Final filtration 0.2 µ
Distribution piping PPl BCF Sanitary
Controls PLC,HMI,TOC,UI Listed
Skid frame Structiural aluminium