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
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.