Verta Life Sciences and Strategic Partners have had leadership roles in the creation of pharmaceutical and biotech manufacturing and support facilities in North America, Asia, Europe, and Africa.
The process we follow usually involves the following major activities:
- Establish project requirements.
- Develop conceptual options to provide the facility space and functional requirements that support the process systems to be accommodated in the facilities.
- Select a preferred facility option.
- Assemble a suitably qualified design team, including process engineering, facility design, structural, mechanical and electrical engineering.
- Produce process engineering and facility design documentation.
- Construct facilities and process system.
- Commission facilities and process systems.
- Qualify facility and process systems.
The key ingredient to the success of any facility project is focused project management. Which ensures the scope (requirements), cost and schedule for the process systems, equipment, and facilities are established at the start of a project and maintained throughout the life of the project.
Verta Life Sciences and Strategic Partners have managed numerous projects to successful completion, on time and on budget.
FACILITY CREATION CASE STUDY
A major international pharmaceutical company wanted to create a new manufacturing plant on its existing campus.
Create a manufacturing plant for solid dosage and liquid products that leverages technology to allow efficient production of short runs of multiple products.
The key criteria by which project managers measure their projects’ performance are scope, schedule and cost. They have to remain in balance. Changes in any one will affect the others. On most facility projects, the process is to define the scope (functional and space requirements) of the project first, then develop an acceptable conceptual design that deliver the requirements. A budget and schedule to deliver the project are developed next. If the budget and/or schedule are unacceptable, the scope has to be adjusted until the three criteria are in balance.
Initial cost estimates and schedules were developed as soon as the project requirements (scope) were known. These estimates and schedules were based on historical information for similar manufacturing facilities.
Our view is that the form of manufacturing facilities should be driven by the functional and space requirements of the manufacturing processes and equipment. It is necessary to understand and design the manufacturing technologies first, before the facility is designed. On this project, task forces were formed to study and evaluate different technologies, including containment, material handling, etc.
Once a decision had been reached on the technologies that would be used, the process/industrial engineers were engaged to develop the concepts for the manufacturing processes and material management systems. Conceptual designs for the building and its systems followed.
More detailed estimates and schedules were produced, based on the manufacturing equipment and building conceptual designs. Once corporate approved, these estimates, schedules and concept designs became the baselines against which the project performance was measured until its completion.
Based on experience on pharmaceutical manufacturing projects, a contracting strategy was developed that allowed flexibility to make changes to the layout and equipment cost effectively. This strategy paid off when a number of changes had to be made during the life of the project.
Project controls focused on monitoring, reporting and controlling the project scope, budget and schedule. When the systematic monitoring identified deviations from the base lines, corrective actions were taken. The project was completed on schedule and on budget in about 30 months and at a final cost of about $105 million (2010 dollars).