AlfaTech Big Book: Life Sciences

L I F E S C I E N C E S

VIVUS

NOVARTIS (CHIRON)*

JANSSEN PHARMACEUTICALS*

Lakewood, NJ

Vacaville, CA

Vacaville, CA

Type: Laboratory, Manufacturing Size: 80,000 SF

Type: VMF OLWX Project Manufacturing Facility Expansion Size: 17,000 SF, two-story building

Numerous upgrade and expansion projects were executed throughout all aspects of the facility including labs, manufacturing process and HVAC systems and building utility upgrades, manufacturing clean room projects, site infrastructure and utilities and administrative tenant improvements. Projects included: • Multi-year plantwide HVAC system renovation and replacement to modernize the plant’s clean room HVAC systems and to meet cGMP requirements. • Process Dust Collection System collecting hazardous dust produced pharmaceutical product manufacturing. • Manufacturing Suite projects to accommodate new products and processes including suite workflow layout, utility system design (electrical, O2, AOF, N2, chilled water, clean steam, etc.), waste streams, Architectural improvements. • Regenerative Thermal Oxidizer • Manufacturing Equipment Safety Upgrades to meet J&J Corporate safety standards • Raw Materials Warehousing and Lab • 1MW Solar Farm Condition Assessment and Upgrades • Manufacturing Washrooms • QC Labs

AlfaTech acted as the owner’s principal engineer for design of a facility that expanded their capacity to formulate and produce a new drug and drug delivery system. The scope of work involved HVAC, process utilities, R.O./D.I. and hot USP water systems, production room layout, and general engineering support. AT also worked closely with the validating agency to provide a complete turnover package.

Full Civil and MEP design services for a 17,000 SF two-story building expansion. The expansion included private offices, open office areas, meeting, conference and storage rooms, corridors, stairs, restrooms, elevator, QA/QC engineering document storage room, QC and raw materials laboratories and process equipment storage, in the following cGMP areas: weigh/dispense room, quarantined and released materials.

BAXTER HEALTHCARE Hayward, CA

NOVARTIS (CHIRON)* San Carlos, CA

Type: cGMP Laboratory

This Hyland Division Laboratory renovation project involved a complete remodel and relocation of the biotechnology process rooms. Construction documents and validation for a cGMP upgrade of the existing facility were also required.

Engineering Design for multiple facility projects including: • Temperature Control for CSD-1 Dryer • Laboratory Humidification System Replacement • Site Energy Manager (Staff Augmentation) • Sitewide Electrical Power Study and Maintenance Plan • Niro-2 Exhaust Modifications (Design/Build Project Delivery)

COLLAGEN AESTHETICS INC. Fremont, CA

• Code Studies • Data Center

NOVARTIS (CHIRON)* Emeryville, CA

Type: Manufacturing Plant Size: 12,000 SF Facilities: • Bulk Processing Area Addition • Office Space Tenant Improvements • Warehouse and Office Space

PAR, FAIRBANK OSD* Facility Master Plan, Irvine, CA

Architecture and Engineering Design for multiple facility projects including: • Site Wide Energy Efficiency Study • Building 4 Lab Tenant Improvements • Robotics Lab Tenant Improvements • Building 4 Executive Conference Center • Building G&T Chilled Water System Upgrades Concept Design

Responsible for Master Planning, Options Development, Programming, and Conceptual Design of the facility. For an existing 90,000 SF OSD Facility that includes manufacturing, QC lab, lab support, warehousing and administrative functions

Collagen Aesthetics Inc. develops, manufactures, and markets on a worldwide basis high quality biocompatible products for the treatment of defective, diseased, traumatized or aging human tissues. This project modified existing Class 100 – 10,000 spaces for laminar flow filling suites for new product manufacturing. The firm maintains Collagen’s library of as-built drawings to support ISO 9001 certification.

* Completed by AlfaTech principal during previous employment