Developing a pharmaceutical product takes many years and hundreds of millions of dollars. With Hexagon PPM's solutions, pharmaceutical companies can gain dramatically better control over their valuable information asset needed to comply with federal regulations, bring new products to market quicker, and eliminate plant shutdowns. They can proactively manage the critical information required to demonstrate regulatory compliance in operating the plant day-to-day, which helps to save time and reduce costs throughout the plant life cycle.
Design, construction, and operation of pharmaceutical and life sciences plants
At every step of the way
- 3D Design & Visualization
- Asset Lifecycle Information Management
- Engineering & Schematics
- Procurement, Fabrication & Construction
As the healthcare and medical industry expands to support increasing demands to improve the health of communities, together with advances in the pharmaceutical industry to offer new drugs, Hexagon PPM's plant design and visualization applications continue to support key aspects of project execution for the pharmaceutical industry, from conceptual plant design through detailed design and construction, into plant operations and maintenance. Some of the world's leading EPC companies involved in the design and construction of pharmaceutical plants, such as Jacobs and Project Management Group, as well as pharmaceutical companies such as Bayer and Eli Lilly, have chosen PPM plant design software for major pharmaceutical projects for the past two decades.
High-value pharmaceutical facilities require very strict standards, and Hexagon PPM analysis solutions can help you design these facilities so they are safer and more reliable. For example, the challenges of clean in place (CIP) designs in many of these facilities, often in constrained locations, can introduce piping stresses that cause mechanical failures that lead to extended closures, while facilities undergo repairs and sanitation for reuse. PPM solutions help eliminate substandard designs that could lead to system failures, which prevents costly closures and provides long-term savings for owner operators.
A new product's plant must be brought to market rapidly to take advantage of limited product patent life. Defining, recording, and auditing the plant's ever-changing operating characteristics can be a challenge. Plus, analyzing and managing the impact of change must be performed in accordance with regulatory and process quality practices. All of this must be achieved in a global market where capital project delivery must not only be fast and efficient, but perfect. This is a significant Asset Lifecycle Information Management challenge that Hexagon PPM has been leading with its customers from around the world.
Pharmaceutical projects are executed in a fast-track mode, because as in many cases, the patent window is small and the investments are high. This forces owners to begin projects often quite early with the risks of changes. SmartPlant® Engineering & Schematics solutions offer fast-track, high-quality design and support of validation and compliance.
With the support of rules and integration, the solutions offer high-quality designs that streamline the validation process. In addition, changes can be implemented easily, quickly, and consistently through the project, once again thanks to the support of the relationships and rules.
To fast-track projects, the plant is made up of pre-fabricated units that SmartPlant Engineering & Schematics can manage and integrate into a uniform design. During operations, the engineering tool needs to support data for FDA inspections, CFR 21 Part 11, and the ability to re-configure the plant and keep a history of the re-configuration for new production campaigns.
For a typical new pharmaceutical facility or extension, 10 to 15 percent of the total cost is for engineering design and 50 to 60 percent of the costs are related to material. It is obvious that surplus materials caused by ineffective materials management, even to levels of only five percent, can result in the loss of millions of dollars on an average capital project. Without continuous management and project performance, it is difficult to take the appropriate corrective action to prevent schedule delays. These delays can often be even more costly when they affect the pharmaceutical facility owner's ability to produce and sell the product. Effectively managing these complicated business processes in an integrated environment throughout all phases of the project life cycle is vital.
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