PROCESS FACILITIES GROUP, LLC

ENGINEERING  •  CONSTRUCTION MANAGEMENT  •  COMMISSIONING   SERVICES

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Recent Projects


Here are some of our recent projects.

 

          

Provided process design engineering, procurement, construction management, and commissioning services to Heron Therapeutics to support the development of a commercial scale polymer manufacturing process that enables extended release of chemotherapy and pain management drug products. Scope included identification and evaluation of existing sites for the manufacturing of these polymers, and development of capital and operating costs. Responsibilities included: process simulation and modeling to optimize scale-up of polymer manufacturing process; site selection and assessment support; preparation of PFDs and PIDs; equipment specifications; and development of capital and operating costs.


                                                     

Provided process engineering services to Teva Pharmaceuticals Pomona, NY facility to assist in process flow configuration and development, as well as equipment design and selection for their scale-up lab that will be utilized to conduct process development and feasibility studies in support of its sterile product development of generic forms of injectable drugs using nanoparticle technology via suspensions, microspheres, and liposomes. Responsibilities included: process simulation and modeling; preparation of PFDs and P&IDs; and technical support for equipment specification and procurement.


  Novo Nordisk

Buildings 1 & 9 New Process

Provided process engineering and startup support services for modifications to existing plant and clean utilities in support of clinical runs of new N8-GP process transferred from Novo Nordisk’s Denmark facility to West Lebanon, NH. Process consisted of cell culture, harvest, purification via chromatography, and pegylation activities utilizing single-use technology. Responsible for redlining existing drawings to create construction documents with sufficient detail to enable modifications by MEP subcontractors. Prepared PFD and P&IDs of overall process to document how process was being run at facility since it was adapted to existing equipment and systems at facility. Services included facilitation of onsite “what-if/checklist” safety review, PM program, and onsite coordination of change control and corrective action activities.


Pacira Pharmaceuticals - Suite C Expansion

Project involved providing on-site program management, facilities and engineering management, process engineering, facilities supervision, and commissioning support for a new expansion suite used to aseptically manufacture a bulk non-opioid extended release painkiller drug from a lipid formulation called EXPAREL.  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, facility/engineering personnel, scheduling on-site vendors, SOP’s, PM programs, change control, scheduling, financial planning, cost control, repair and maintenance, construction of facility suites, off site / on site warehouses, fill line suites, bulk sterile API manufacturing, construction, installation, commissioning and startup of a new bulk sterile API suite, autoclave, plant and clean process utilities, CIP/SIP/COP systems.

Process engineering support included an evaluation and reduction of the overall batch cycle time to less than 24 hours/day by redesigning SIP and CIP circuits, moving TFF to a COP wash station and cleaning with isopropyl alcohol, and increasing the capacity of CIP chemical feed pumps.  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, and temperature control skid.

Scope of services included: scheduling on-site vendor support; preparation of manufacturing and preventative maintenance SOPs; LOTO program; preventative maintenance programs; preparation of change controls; risk assessments; preparation and tracking of capital appropriation requests; creating as-builts of process and utility system P&IDs; and preparation of project schedules.

 


Pacira Pharmaceuticals - Suite C TFF IPA COP

Conducted a feasibility study to assess the effectiveness of using isopropyl alcohol to Clean-Out-of-Place (COP) the tangential flow filter (TFF) cartridges associated with the bulk EXPAREL manufacturing process in Suite C in order to extend the number of uses of the TFF cartridges, decrease the overall cycle time of clean-in-place (CIP) of the EXPAREL process, and define the requirements to allow implementation in both Suites A and C.  Due to the nature of the lipids associated with the EXPAREL manufacturing process, the CIP of the TFF cartridges with caustic and acid proved to be ineffective.

Isopropyl alcohol was used since it was very effective in dissolving the lipids.  A COP station was designed using isopropyl alcohol to clean the TFF cartridges.  This important cleaning step would improve the reliability of the TFF cartridges which wwould lead to less down time and remove the need to change the TFFs out so regularly.  The objective was to be able to use the TFF cartridges for up to 6-8 batches instead of changing them out every 2-3 batches.  This change had a significant cost savings to the cost of goods, since each TFF cartridge costs $6,000.

Worked with Pacira’s process development engineers and chemists to conduct experiments to prove and document effectiveness of cleaning the TFFs with isopropyl alcohol.  Resulting data was used as basis for design and equipment sizing and selection.

Scope of services included: process design; preparation of PFDs and P&IDs; preparation of URS and Basis of Design documents; preparation of capital appropriation request; specification and procurement of equipment and instruments; piping design and supervision of piping contractor; preparation of SOPs; preparation of change controls; start-up and commissioning; operator training; and weekly budget and schedule tracking

 


Pacira Pharmaceuticals - AMCEC Upgrade

Pacira operates an existing steam stripper system designed, fabricated, and supplied by AMCEC to remove methylene chloride from the vent gas and liquid waste streams from the bulk EXPAREL manufacturing process.  The system consists of three skids:  a low temperature chiller/condenser skid, a carbon adsorption skid with a decanter tank, and a steam stripper skid featuring an 8 in. diameter x 21 ft. high packed stripper column.  A stripper feed tank collects process wastewaters containing methylene chloride from the manufacturing suites and serves as feed reservoir for the steam stripper system.  All of the skids and the feed tank are located outdoors in the service yard of Building 1.

Vent gas from the manufacturing process, containing methylene chloride and water vapor is first processed in the low temperature chiller/condenser skid for removal of a major portion of the water and methylene chloride vapors.  A condensing temperatureof –35oF is used.  The treated gas with residual methylene chloride leaves the chiller/condenser skid and is routed to the carbon adsorption skid for to further reduce the methylene chloride concentration to acceptable limits prior to being vented to the atmosphere.

Liquid waste from the manufacturing process also contains methylene chloride which must be removed prior to discharge to sanitary sewer.  The methylene chloride is stripped in the steam stripper skid via steam stripping, and then condensed and collected in 55-gallon drums for disposal by a contract hauler.  The resulting wastewater is subsequently pH adjusted in the neutralization system and discharged to the city sewer.

A second AMCEC stripping column was added to increase the overall capacity of the treatment system to handle the vent gas and wastewater load from the Suite C expansion project.

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.

 


Pacira Pharmaceuticals - B6 Spray Process

The scope of this project involved the design, construction, and start-up of a “Clinical” version of an existing laboratory scale Spray Process into the existing R&D laboratory in Building 6.  The capacity goal of this Clinical Spray Process was to enable a 4-hour clinical run to produce 16 liters of EXPAREL product and to produce it aseptically.

Pacira developed this new clinical spray process which was capable of operating in a continuous fashion to produce 16 liters of EXPAREL at the rate of 4 liters/hr compared to the batch manufacturing process used in Suite C that generates 45 liters of EXPAREL.  Methylene chloride is used as the solvent in the Suite C process and is replaced with chloroform in the clinical spray process.  The spray process product meets all release specifications for EXPAREL.

Scope of services provided included: process design and detailed engineering for the installation of an aseptic spray drying process in an existing R&D laboratory; preparation of priced equipment list to support preparation of capital appropriation request; preparation of PFDs and P&IDs; equipment layout drawings; environmental permitting support; preparation of equipment and instrument procurement specifications; review of vendor shop drawings; attendance at FATs; field engineering support during construction; and start-up.