Pacira Pharmaceuticals - Suite C Expansion
This project involved providing on-site program management, facilities and engineering management, process engineering, facilities supervision, and commissioning support for a new expansion commercial manufacturing suite. Suite C was designed and built to aseptically manufacture a bulk, non-opioid, extended-release painkiller drug from a lipid formulation called EXPAREL. PFG coordinated daily activities with facilities, manufacturing, QA, validation, and automation personnel with direct reporting to the General Manager.
Responsibilities involved managing daily facility/engineering activities in liaison with QA, manufacturing, IT, and facility/engineering personnel while scheduling on-site equipment vendors during start-up and commissioning:
- SOP's
- PM Programs
- Change Control
- Scheduling
- Financial Planning
- Cost Control
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- Repair and Maintenance
- Construction of Facility Suites
- Off-Site / On-Site Warehouses
- Fill Line Suites
- Bulk Sterile API Manufacturing
- Construction
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- Equipment Installation
- Commissioning and Startup New Bulk Sterile API Suite
- Autoclave
- Plant and Clean Process Utilities
- CIP/SIP/COP systems
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The process engineering support included an evaluation and reduction of the overall batch cycle time to less than 24 hours/day. This was achieved by redesigning SIP and CIP circuits, moving the TFF to a COP wash station for cleaning with isopropyl alcohol, and increasing capacity of CIP chemical feed pumps. Lastly, PFG started up and commissioned all clean and plant utilities, including CIP/SIP/COP systems, methylene chloride storage and feed system, clean steam generator, WFI Still, solvent steam stripper skid, and temperature control skids.
Scope of services included: process engineering support for the start-up, operation, and operator training of the new steam stripper skid supplied by AMCEC including an assessment of the existing utility systems; investigation of existing utility generation system capacities and distribution; construction support during the shutdown and installation of the 2nd AMCEC stripper column; start-up and commissioning assistance; preparation of an operator training manual; and on-site operator training.