Cook Pharmaceutical Solutions Bloomington, Indiana:
I managed the design and construction of Cook Pharmaceutical Solutions’ first manufacturing plant and the president called me back for a site visit. During the visit he asked me to help him develop a plan to expand.
Our timeline was a year and a half, about ten months shorter than is typical for this sort of project.
We evaluated various options to achieve this goal and determined that using a modular approach would be best for meeting the tight schedule.
This would be the very first modular pharmaceutical plant to be built in the US.
This project included stick-built offices, laboratory, utilities, receiving, and finished goods warehousing. The intent of the plant expansion was for the manufacturing of pre-filled syringes.
A future second phase expansion was to include sterile filling of both liquid and lyophilized products.
During the implementation of the initial project, it was decided to pursue the planned future expansion concurrently. The work in preplanning for the second expansion phase during the design of the first allowed for on-time and on-budget completion of both projects.
Because of foresight in the design and planning for both expansions, we avoided potentially long interruptions to production and avoided increased project costs.
Not only did the entire project meet our accelerated timeline, FDA compliance was maintained and no 483’s were issued.
Some challenges that were overcome were:
- Maintaining production in the existing manufacturing area
- Getting permits for a new type of construction
- Planning the project and keeping the FDA informed of the new construction methods and quality planning
- Shipping the modular pods from Sweden to Bloomington, Indiana
- Integrated validation into the construction to expedite the qualification of the site to meet FDA guidelines
Cardinal Health – Albuquerque, NM.
Cardinal Health needed to upgrade their facility to meet current FDA requirements.
I was engaged to manage the renovation project to a portion of their existing manufacturing facility. Maintaining operations was one challenge we faced.
The project had a short schedule due to the need to maintain the inventory of sterile, lifesaving drugs. The plan was to start the shutdown over Memorial Day weekend and have the facility ready for validation by Labor Day Weekend with production re-starting in October.
We also faced a shortage of quality labor. Importing labor from nearby states and rigorous scheduling allowed the project to be delayed only by three weeks.
A third challenge was in owner supplied, pre-purchased equipment needing significant modification to meet the current project requirements.
Cardinal Health also hired us for the validation for the project. This enabled the integration of validation with construction. This allowed production to resume in October as planned.
Production was resumed on-time, and the inventory of life-saving drugs did not run dry.
Some challenges that were overcome were:
- Inaccurate as-built drawings
- Production demands disallowing a thorough review of existing conditions
- A shortage of quality labor due to local conditions
- Owner supplied equipment requiring modification
- Good relations with local contractors and building inspectors needing to be re-established
Universal Products – Fort Worth, TX
The head of product development had worked with me on a previous project and asked if I could validate some new processes at their new start-up company.
Our initial goal was to validate equipment and processes, but upon coming to the site I learned that they were lacking the framework that is required to complete any validation effort.
We modified our agreement to help them set up a Quality System and organize the technical service department.
Once the basic FDA compliance issues were corrected and their new department trained, they were able to validate their process internally.
We helped them find a permanent solution to what would have been a temporary fix, and they reduced costs overall.
Some challenges that were overcome were:
- Helping the start up company understand FDA requirements
- Convincing the owners that the processes do require validation
- Training the staff in GMP’s and proper documentation practices
- Incomplete equipment commissioning prior to the validation process
Patheon – Bend, Oregon
Patheon’s newly acquired API contract process development company located in Bend Oregon needed some additional processing areas and upgrades to enhance GMP compliance in accordance to corporate goals. The project team needed an experienced project manager, so I was hired to fill that role, reporting to both corporate and site management.
The project scope included: adding additional processing areas, new manufacturing processes, some upgrades to the existing manufacturing areas, and updating the critical utilities supporting both the current and new production suites. This work was completed while maintaining current production demands.
The primary friction of the project was a needed paradigm shift, including personnel from the line workers to the plant manager. The new corporate guidelines requires a certain level of documentation and facility upgrades unfamiliar to the plant.
Some challenges that were overcome were:
- Meeting new corporate standards
- New engineering of the facility to meet the corporate guidance
- Changing of general contractors between the planning and building phases
- Understaffed project team
- Maintaining production during construction
- Underqualified validation contractors
Confidential Client and confidential products – Non-Pharma Government Client
The product to be manufactured already existed, but the goal of the project was to automate the process for lower per-unit cost and higher quality, as well as to relocate the manufacturing to reduce shipping costs.
For the feasibility study, we reverse engineered the existing product to develop many new, highly automated manufacturing processes.
We developed production methods for various metal processing, including stamping, welding, coating, and assembly.
The requirement of near total automation made the project very unique. Highly specialized equipment required much research for selection, and the unique nature meant no layout pattern to follow existed.
Some challenges that were overcome were:
- Little knowledge of existing manufacturing process
- Assembling a qualified team due to the specialization
- Confidentiality added a degree of difficulty for research and suppliers
I was asked to help on another project, a phase in achieving a long term goal. This phase is a product development facility (bridge between research and manufacturing).
The main service I provided was to distill and organize many wants and needs into viable goals and objectives.
From there, we developed equipment, personnel, and safety requirements, layouts, and estimated cost for the facility.
The project is currently in the implementation phase.
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