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