Delta prides itself on our track record of successfully delivering projects within the Regulated Life Science Industries.  


A sample of completed projects is provided below:

 

Validation of Facility

Location: Redwood City, CA    /    Year Completed:  January 2014 –  July 2015

Budget: +$800k

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

  • Spray Dryer
  • Capsule Filer
  • Emulsion Preparation
  • 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.