Strategic Planning Considerations in Pharmaceuticals Plant Design
According to statistics portal Statista, which reports on studies and statistics from nearly 23,000 sources, the U.S. market for pharmaceuticals is the most important national market in the world. In fact, six of the top 10 global pharmaceutical companies are in the U.S. It is estimated that consumers in our country spend a total of more than $450 billion on medications annually. Building plants that can keep up with demand while adhering to the Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMPs) requires significant strategic planning.
Key Requirements for Plants That Manufacture Pharmaceuticals
Because of the U.S. pharmaceutical industry’s impact on the health and wellbeing of the population, there are more rules and regulations covering the operations of these companies than those in any other industry. For full service engineering firms like APECS, this makes strategic planning in advance of the kickoff of a building or remodeling initiative critical. The safety both of plant workers and consumers is at stake, as is the efficacy of the drugs produced using the processes designed.
Below are some of the requirements we keep in mind as we collaborate with companies that produce pharmaceuticals. Ensuring that they are all properly addressed helps organizations operate efficiently, cost-effectively, and in compliance with all the applicable regulations associated with their product.
- CGMP requirements. Before a project begins, it is important for an organization and the engineering firm they are working with to know what FDA requirements apply to the facility as a whole as well as to the specific pharmaceuticals they will be producing in the facility. There can be both country-specific and worldwide rules in effect depending on where the medication will be marketed. Often the requirements cover personnel supervision and training, equipment location, design and installation, and plant processes. It is also important that standard operating procedures for ensuring product quality and preventing cross-contamination between products or even between different batches of the same product are developed.
- Facility and environment requirements. The buildings, wings or departments, rooms, and spaces in which pharmaceuticals are developed, manufactured, tested, and stored must have the appropriate amount of space for machinery and operators, separation between operations, and access points for materials and personnel. The way a facility is laid out can play a significant role in minimizing the risk of mistakes in the production of pharmaceuticals. Strategic planning also helps manufacturers identify and address issues related to air movement and filtering, electrical needs, and water supplies. Protection of the exterior environment around the plant is also vital.
- Special materials and services. The manufacturing of pharmaceuticals often requires special materials like clean steam, filtered gases, and deionized water. How and where those materials will be made available to production processes is key.
- Materials movement. Because cross-contamination can have serious consequences, the movement of raw or unfinished materials around a plant is closely scrutinized. Quantities, routes, and other factors are carefully considered for the use of materials in processes as well as their storage and sampling. The environmental conditions throughout the plant must be accounted for in the strategic planning and design as well.
- Plant personnel and visitor movement. From machinery operators to touring company executives to government inspectors, the optimized plan for a pharmaceuticals plant must take into account how people will move safely and efficiently from one area to another. In some cases, features like airlocks and cleaning areas must be included in the design.
- Machinery and equipment repositioning. Whether it is a recurring event or a one-time relocation, it is important to consider how machinery and equipment should be moved from one area to another. Failing to assess these kinds of issues can lead to inefficiencies or even violation of company or government requirements.
Strategic Planning That Delivers Exceptional Results
The design, construction, and launch of a plant for producing pharmaceuticals is a time-, labor-, and capital-intensive process. Strategic planning and collaboration with a company that specializes in full service engineering and design, project management, capital planning, and environmental health and safety can help ensure that those resources are used to maximum effect.
APECS achieves outstanding results in pharmaceuticals plant design because of our 30+ years of experience helping our clients meet their engineering, design, project and portfolio management, capital planning, and environmental health & safety needs.
Contact APECS, Inc. today to learn more about how we can help with your pharmaceuticals plant design project.