ESPACIOS EXTERIORES

An API project is created when a need arises through one or more of several areas. Some examples include: (1) new pro-duct intropro-duction, (2) regulatory requirements, (3) existing product capacity shortfalls, and (4) process improvements.

Any one or combination of these areas can generate the need for a new capital investment.

The engineering and construction steps are similar for the four stated cases. Excellent scope definition and a well thought out execution strategy are required for all of them. A firm will analyze many different manufacturing options before estab-lishing the final project scope. The most uncertainty occurs with the new product introduction. The firm can be required to develop a preliminary scope of work during early stages of process development. There is a higher probability of change and process churn as the new process develops. The firm must be prepared to manage facility and equipment changes as the new process is finalized. The key to success is both minimizing and coping with those changes. The uncertainty in the volume of production requirements can also change during the initial scope development of a project.

The other business cases normally have a defined process within existing operating facilities and with known market volumes having already been on the market. The major pro-cess components have already been defined. The propro-cess is a regulatory agency-approved process, which has proven viabi-lity. Normally, the changes associated with these types of projects are limited in scope to process enhancements, i.e., increasing throughput, eliminating bottlenecks, increasing yields, etc. We will not focus the discussion on these types of projects.

We will focus on the requirements of engineering and construction of facilities for a new API introduction. This is the most difficult and complex task because the technology is untested on a commercial scale and there are technical assumptions with the associated risks that must be taken.

Assuming the product and the process are untried at commer-cial scale, there may be unforeseen issues with start-up and

operation that arise at the proposed scale for the new API entity. Certain components of the process, such as product handling and transfer, and material consistency may become an issue at the production scale, which were not detected in a pilot or bench operation. The design team must take into con-sideration any components of the process that will not be a scaled-up duplication of the laboratory version of the process.

The risk of a pump or product transfer system not working properly because of material viscosity or incompatibility may require changes to the process once the system is built.

Material handling aspects through equipment such as centrifuges, blenders, or mills can be different from the smaller-scale experience. Common problems that develop at commercial scales include pumps not operating as designed, material bridging in centrifuges and blenders=dryers, and different milling consistencies. The engineering and construc-tion team may be required to change components during the initial production runs of a new compound. A good designer will incorporate the necessary flexibility in the new process to allow for equipment change outs. The design of equipment should incorporate the ability to replace it or upgrade in a manageable fashion.

A benefit for the readers is the ability to utilize this strategy for other process improvement or regulatory-driven projects. The steps are similar if not the same (the major dif-ferences are associated with the business and engineering analyses for the new API).

A. An API Manufacturer Will Focus on the Appropriate Level of New Capacity

Market projections will indicate required volumes of the new API. Unfortunately, market projections can vary widely.

Manufacturing capacity for a new API facility is expensive to build, maintain, and operate. It is important to ‘‘properly size’’ the production processing equipment and supporting facilities. A proper engineering approach will incorporate the ability to expand a production facility or equipment train(s) to allow for future expansion for potential volume

increases. The future expansion planning can be as simple as incorporating the footings for a building expansion during construction of a new facility. It can be as complex as adding an additional bay to a new or existing building along with all associated utilities for that future expansion.

B. The New API Manufacturer Will Focus on Flexibility in Design

A key component of the analysis is whether to produce the new API with dedicated process trains and facilities or to campaign the new product with other products utilizing simi-lar equipment. Major new API compounds may warrant dedi-cated process trains and facilities due to the sheer volume of product or due to unique processing techniques. However, most new higher-potency APIs can be produced with less equipment over a shorter time span than in the past, thus allowing the manufacturer to produce multiple products within the same equipment. This approach can often result in significant conservation of capital.

C. Location of the New Facility

The new facility can be located in any of the major markets in the world. Many countries provide tax incentives for locating an API production facility in their country. Labor markets are an important component of the analysis. The technical skills required to operate and maintain the facility and for construc-tion and start-up are sophisticated. Complex processes require skilled technicians to run the process. Skilled mechanics will be required to maintain the facility.

Sophisticated equipment and facilities require skilled labor and construction professionals. It is difficult to construct and maintain one of these facilities in a remote part of the world and certain parts of the United States. Labor markets are lim-ited. The new facility may compete with other facilities under construction for the available labor and construction support resources. Major API and biotechnology projects have recently experienced large cost impacts, both in the United States and foreign locations, because of a dearth of trained construction

and engineering professionals to design and construct these facilities. Site selection should be one that offers an acceptable supply of operational support and construction resources.