We pride ourselves on our successful track record of executing projects within the Regulated Life Science Industries.
Examples of previously completed projects:
Validation of Facility
Location: Redwood City, CA / Year Completed: January 2014 – July 2015
Client planned to move into a ~40K sq. ft, multi-story, multi-tenant building that will contain a GMP manufacturing facility (controlled environment), GMP Pilot Plant (suitable for clinical trial supply and scale-up work), GMP grade warehouse for commercial/clinical materials, R&D labs, and offices/conference rooms/cubicles.
Project Deliverables: The project scope activities were grouped into three areas:
Facility (including BMS Data Historian, HVAC, Warehouse Temp. Mapping)
Utilities (Purified Water, Nitrogen Distribution)
Process equipment (Spray dryer, Homogenizer, High-Shear Mixers, Glove Box, Parts Washer)
Development of qualification documents that included Site Master Validation Plan, URS, VMP, RA, TM, IOPQ Protocols, Validation Summary report generation.
Responsibility for leading project team meetings and schedule and cost management.
Spray Dryer Capacity Increase C&Q
Location: San Carlos, CA / Year Completed: July 2013 – June 2015
C&Q Budget: $1.25MM
Project seeks to renovate existing office, lab production areas, and unused space on site to great additional GMP Manufacturing capacity by adding a new Spray Dryer and Capsule Filler suite. Delta PM partnered with Dome Construction (General Contractor) to be their project C&Q group.
Area Process Equipment
Equilibration equipment for capsules
Equipment parts washer, drying oven, and CIP System
Utility and Infrastructure Upgrades
New Air Handler Units
Extension of existing utilities – Qualified (RODI, CDA, Process Vacuum) and Commission-only (Chilled Water, Hot Water, Cooling Tower Water, Plant Steam, Electrical, Process Waste Water)
Additional BAS points for infrastructure utilities
Aseptic Fill Suite C&Q Project
Location: Fremont, CA / Year Completed: April 2014 – May 2015
Owner’s Rep: Confidential/ Budget: $500k
DPM was selected by a CMO to provide Commissioning & Qualification support for a new aseptic fill facility that will allow the site to utilize an aseptic isolator fill line for new products coming into the facility.
Isolator was designed to provide Grade A EU (US Class 100) environment with an integrated hydrogen peroxide decontamination system, and Glove Tester.
Syringe Filler designed for filling and closing of pre-sterilized syringes in tubs.
Also in scope was a Belimed parts washer and Steris autoclave. Performed IQ/OQ and CD/PQ on both systems.
DPM also qualified the following supporting utilities: Nitrogen, WFI/RODI, CDA, and Clean Steam and dedicated HVAC servicing the Isolator.