"When you're focused on a commitment, and have the perseverance to see it through, and lead by your own actions, you are on the quest for excellence."
- Michael O'Callaghan, Partner/President/Program Manager

Process Design Engineering Services and More for Your Facilities

Here are some of our recent projects:

Heron Therapeutics

Provided process design engineering, equipment procurement, construction management, commissioning, and validation services to Heron Therapeutics to support the development of a commercial scale polymer manufacturing process to be used for extended-release of chemotherapy and pain management drug products. Scope included identification and evaluation of existing sites for the manufacturing of these polymers and the 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.

Teva Pharmaceuticals

Provided process engineering services to the Pomona, NY facility to assist in process flow configuration and development. PFG provided preliminary equipment design and selection for their scale-up lab to be utilized to conduct process development and feasibility studies. The new integrations were to support 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 technical support for equipment specification and procurement.

Novo Nordisk

Buildings 1 & 9 New Process

PFG provided process engineering and startup support services for modifications to existing plant and clean utilities in support of clinical runs of the new N8-GP process transferred from Novo Nordisk's Denmark facility to the West Lebanon, NH facility. The process consisted of cell culture, harvest, purification via chromatography, and pegylation activities utilizing single-use technology.

Responsibilities included redlining existing P&IDs and facility drawings to create construction documents with sufficient detail to enable modifications by MEP subcontractors. Prepared PFD and P&IDs of the overall process to document how the process was being run at the facility to allow the manufacturing team to see the outcome of adapting to existing equipment and systems at the facility. Services included facilitation of on-site "what-if/checklist" safety reviews, development of PM program, and on-site coordination of change control and corrective action activities.

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

Repair and Maintenance
Construction of Facility Suites
Off-Site / On-Site Warehouses
Fill Line Suites
Bulk Sterile API Manufacturing
Construction

Equipment Installation
Commissioning and Startup New Bulk Sterile API Suite
Autoclave
Plant and Clean Process Utilities
CIP/SIP/COP systems

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.

Pacira Pharmaceuticals - B6 Spray Process

The breadth 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 capable of operating continuously 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 met 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; process modeling and simulation; preparation of priced equipment list to support the 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.