Purified Water – Andover, MA
Upgraded existing purified water systems to meet cGMPs and FDA approval and included expanded water production, purification, circulation and maintenance, and also conducting a cGMP Audit of existing pretreatment, treatment, storage and distribution systems. Compliant gaps and specify remedial actions were determined and User Requirement Specifications (URS) and Design Specifications were developed for new ambient water ozonation system and new hot water purified water storage tank. Responsible for complete system engineering, contractor RFQs, bid evaluation, detailed design, project management installation supervision and qualification.
Biopharmaceutical – Boca Raton, FL
Upgraded an existing fractionation facility, including Developing User Requirement Specifications, Process Design, Utility Sizing, P&IDs, Design Specifications, Functional Specifications, and Validation Master Plan in compliance with cGMPs.
cGMP Consulting – Carlsbad, CA
Upgraded an existing reagent facility to meet cGMP requirements. The project included performing cGMP Gap analysis on facility construction, air, personnel, material and waste flows, process equipment, sanitary piping installation, instrumentation and controls and available qualification documentation. Standard operating procedures were audited and compliant issues were identified with recommended remedial actions.