McGhan Medical

Santa Barbara, CA.

New 60,000 SF breast implant manufacturing facility, validated systems included, process chilled water, CDA, USP Pure Water system; Mixing rooms, Coating rooms, Testing & Packaging rooms, Sterilization rooms and Class 100 production hoods.

Chiron Aids Test Kit Manufacturing Plant

Vacaville, CA

New 65,000 SF aids test kit manufacturing plant.  Systems included high pressure clean steam, LN2, CIP USP water, CDA, validated refrigerated storage, and process chilled water.

Bayer Biotechnology, Establishment Licensing Applications (ELA)

Berkeley, CA

Documentation for manufacture of multiple pharmaceutical products in a 150,000 sq. ft. multi-purpose biotechnology manufacturing facility.  Documentation included development of room utilization plans, production equipment utilization plans, air cleanliness classification plans, USP purified water system plans and schematic diagrams, hot and cold WFI system plans and schematic diagrams, clean steam system plans and schematic diagrams, process CO2 and O2 system plans, process compressed air system plans and schematic diagrams, HVAC system plans and diagrams including room differential pressure plans, raw material flow diagrams, in- process and finished product flow diagrams, solid and cell waste flow diagrams, equipment flow diagrams, personnel flow diagrams and pest control diagrams.

Bayer Biotechnology, Process Manufacturing Tank Modifications

Berkeley, CA.

Design of acid (acetic and hydrochloric) injection system for manufacture of buffer solutions in fixed 1,500 liter stainless steel vessels.  Investigation and design of production tank agitator modifications to allow proper mixing of buffer and media solutions.

Supergen R&D GLP Laboratory

Pleasanton, CA

New 10,000 SF building housing the GLP Research and Development laboratories for this drug discovery company.

Bayer Biotechnology, Purification Equipment Modifications

Berkeley, CA

Design of modifications to chromatography equipment including installation of pressure relief valves on columns and installation of stainless steel gearboxes, couplings and motors for product transfer pumps (rotary lobe type).

Bayer Biotechnology, Critical Production Equipment Spare Parts

Berkeley, CA.

Identified and specified critical spare part inventory for all process related equipment and systems installed in a 150,000 sq. ft. multi-purpose biotechnology manufacturing facility. Equipment included fermenters, chromatography equipment, tanks, agitators, rotary lobe pumps, peristaltic pumps, ultra filters, clean-in-place equipment, sanitary pumps, utility system pumps, heat exchangers, stills, HVAC equipment, cooling towers, compressors, technical gas systems, incubators, water baths and refrigerators.

Syntex Validated Warehouse

Newark, CA

Design and validation of a new 20,000 SF validated warehouse, with 5,000 SF storage and quarantine areas maintained at ± 2°F and ±4% RH.

Bayer Biotechnology, Hazmat Storage Module

Berkeley, CA

Design and Project Management of prefabricated hazardous material storage modules.  Storage module design included secondary spill containment, dry chemical fire extinguishing system and alarm, explosion relief panels, explosion proof lighting, ventilation fans and self contained 12 volt battery powered electrical power system that utilized solar charging.  Modules were utilized for storage of flammable QA Quarantine and Release material used in cGMP production.

Bayer Biotechnology, Central Refrigeration System

Berkeley, CA

Review of variable flow 3,600 GPM central chilled glycol distribution piping system.  Managed recommendation and implementation of modifications for pressure differential control of distribution loop.  Review of 1,500 ton capacity refrigeration generation system utilizing ammonia compressors.  Designed and managed installation of 800 ton capacity refrigeration generation plant to supplement existing 1,500 ton system.  Supplemental system was designed, installed and operational in 8 weeks.  Supplemental system was installed and placed on-line without interruption of existing operations.

Syntex S2 Research Laboratory

Palo Alto, CA

Renovation of an existing 25,000 SF research laboratory to accommodate new Microbiology, Analytical Services, Health Physics Radioactivity, Consolidated Compound Inventory, and Bio-analytical and Metabolic Research laboratories.  Systems included new fume hood and bio-safety exhaust systems, complete renovation of the HVAC and temperature controls, de-ionized water system, autoclave and bio-decontamination system, laboratory waste and neutralization system, and laboratory gas systems.
Bayer Biotechnology, Central Utility Planning, Berkeley, CA:  Member of the Central Utility Investigation Team providing recommendations for future expansion and upgrades to the campus utility systems.  Systems investigated included central validated compressed air, O2, CO2, and refrigeration.  Developed demand curves for future expansion of these utility systems.  Analyzed and identified critical use and redundancy requirements for utility generation equipment based upon analysis of single-fault scenario.  Developed preliminary cost estimates for implementation of alternatives.  Provided recommendations based upon cost savings resulting from increased efficiency, reduction in maintenance and increase in life cycle.

3M Pharmaceutical, Pure Water System

Northridge, CA.

3M Pharmaceutical, Refrigerant Propellant System

Northridge, CA.

Bayer Biotechnology, Central Compressor Plant Renovation

Berkeley, CA.

Managed review, design and renovation of 110 psi, 700 cfm central validated compressed air utility generation plant.  Review of compressed air system resulted in removal of two 125-hp compressors with associated dryers from project scope by rearranging piping to improve system efficiency.   Project included removal of two existing high-pressure steam boilers and reconfiguration of exiting structure.  Project was performed without interruption of high-pressure steam and compressed air utility services.

Chiron Corporation, USP Purified Water Generation and Distribution Systems

Emeryville, CA.

Member of corporate water system team that included representatives from Production, Validation, Regulatory Affairs, Maintenance, Engineering and Quality Assurance.  Managed design review of numerous USP purified water generation and distribution systems installed on the Emeryville campus.  These systems were installed in licensed diagnostic and therapeutic pharmaceutical manufacturing facilities.  Provided and implemented recommendations to improve purity and performance of numerous systems.

Chiron Corporation, Depyrogenation Oven Modifications

Emeryville, CA.

Management, review, design and implementation of modifications to a through-wall depyrogenation oven installed in a therapeutic manufacturing facility utilized for aseptic packaging. Modifications included installation of oven chamber air pressurization controls and alarms.

Bayer Biotechnology, Building 28A Animal Research Facility

Berkeley, CA.

This 48,000 SF research animal facility was renovated for strategic and development projects.  This project upgrades the building infrastructure and brings the building into current AAALAC standards.  The project includes relocation of the Surgical Suite and support spaces, Radioisotope Laboratory and Animal Quarters, Quality Assurance Cold Boxes and Storage, Pre-clinical Development Laboratory and support offices.  Freezers throughout the building will be consolidated into a new Freezer Room, and new Pharmacology Offices will be provided.  New air handlers, exhaust systems, sanitary sewer upgrades and building controls will be installed.

Penta Biotech, Manufacturing Facility

Union City, CA

New 10,000 SF cGMP manufacturing facility for powder form active pharmaceutical ingredients.  Validated systems include compressed air and nitrogen, USP water, and room pressure differentials.  Large quantities of solvents required H2 designation of two control zones, and explosion control measures using dilution.  Roof exhaust systems required special care for design of the exhaust plume from the nine process exhaust fans.

Bayer Biotechnology, Building 57 Purification Suite Cold Rooms

Berkeley, CA.

Modifications to the existing cold rooms for use as cGMP Purification Suites for the manufacture of pharmaceutical products.  This project is currently in design, and includes modifying these unventilated cold rooms to accomplish Class 10,000 standards, and correct other deficiencies within the cold room including lighting, fire protection, finishes, doors, CIP connections, sanitary pipe supports and pass-throughs.  A new desiccant dryer/air handler and low temperature chiller and back-up chiller are provided.


Milpitas, CA

This 60,000 SF research vivarium facility includes animal breeding rooms, laboratories (surgery, necroppsy, micro-injection), animal quarantine, cold rooms, equipment rooms, lab support, and offices.  Design includes new air handler , exhaust systems, sanitary sewer upgrades, RO/DI, CO2, VAC, CDA, N2 system and building controls.

Ortho McNeil

Menlo Park, CA

This 12,000 SF project upgrades the building infrastructure and brings the building into current standards for production of anti-pregnancy skin patch kits.  Areas included labs (polymer, skin, excipient weigh, weigh staging, analytical development, and process extrusion), hot room, validated warehouse and office support areas.  Design includes 100% outside air system with pressurization/ separation.