Any Time, Any Place, Any Product: A Roadmap for Successful International Pharmaceutical Plant Construction Projects

Modularization and preassembly vs. onsite decisions — The benefits of off-site fabrication are well-documented (Pharmaceutical Manufacturing, September 2004), and modular construction can help:

1. Mitigate site labor shortages and weather-related delays;
   
   
2. Improve quality compliance, since shop fabrication programs ensure a higher quality installation;
   
   
3. Reduce the impact of labor interruptions, and the project’s social and environmental impact.

However, modularization is not a panacea. Many countries discourage any discretionary imports, offering tax benefits for the use of local engineering, construction and materials, so a thorough cost/benefit analysis is critical.

Electronic Tools — When properly applied, electronic design, project management and construction tools can dramatically improve coordination. However, the project must be properly configured and managed to best use these modern conveniences:

1. Communication — E-mail communication is convenient, but it should not be overused. In international projects, particularly, the potential for misunderstandings is great. In general, if the subject is complicated or controversial, pick up the phone.
   
   
2. Site infrastructure — Don’t assume that an adequate communication infrastructure exists in remote locations. In less-developed areas, phone and wireless access are more difficult to set up. Many people assume that, with a satellite receiver in place, the issue is resolved. However, some countries do not allow unpermitted transmissions and obtaining an appropriate permit from local authorities or communication agencies can take months
   
   
3. Centrally hosted project collaboration systems — It’s now widespread practice to maintain all project documentation in a central database, accessible by the engineer, constructor, key suppliers and owner. For pharmaceutical projects, the main advantage of these systems is the fact that they allow team members to reuse the engineering data, stored in templates, for commissioning and validation.
   
   
4. Remote design review — Many projects use 3-D engineering tools and project database systems to provide a virtual representation of the proposed project. These tools offer benefits over 2-D technology, but maximum benefits are obtained when all project team members use the model for planning and scheduling their work.

Cost estimating — A common source of severe estimate swings is the broad application of U.S. or European productivity standards. Construction productivities vary significantly around the world, primarily due to local work practices, tools, work hours, governmental influences and customs. In addition to estimating systems, project cost systems should be tested and proven capable of dealing with multiple currencies and conversions.

Facility qualification strategy & validation master plan — Without the approval of the appropriate drug regulatory agency, pharmaceutical plants become the “white elephants” that every CEO dreads. With international projects, the regulatory approval requirements are likely to involve multiple agencies, complicating the design process. Facility design must consider the “worst case” regulatory position of each of the various agencies.

Risk assessment/mitigation — The project manager must conduct an early assessment of the risks expected, and categorize each based on the likelihood of it occurring and its potential severity. The assessment is a living document — as the project progresses, some risks will go away as new risks emerge.

3. Engineering — Designing for the region, serving the world

For many international projects, the conceptual and preliminary engineering scope will be executed in a region close to the owner’s technology center, or in an area where specific process engineering expertise is available. The execution of the detailed engineering, however, is typically performed in the international region where the project is to be located.

By splitting the design in this way, an owner is usually guaranteed the best of both worlds — a front-end definition package by a world-class engineering firm and construction drawings prepared in a location familiar with the site’s codes, permitting requirements, local materials, climate, workforce and design standards.

Owners and consultants should focus their attention on the following:

• Engineering (3-D vs. 2-D) — Most projects in developed regions have migrated to 3-D project execution platforms. However, if the local contractor doesn’t have experience with 3-D, many of the benefits can be lost, and converting data from 3-D back to 2-D is more expensive than using 2-D methodology from the start.
  
  
• Engineering data — At the outset of the project, the owner and engineer should commit to the central management of the project data, with the goal being to migrate data to the commissioning and qualification templates. The data is thus available for commissioning, validation and, ultimately, the seeding of the owner’s operations and maintenance system.
  
  
• Materials and specifications — Throughout the engineering process, the owner and engineer should be aware of the differences in tolerances for international materials, and the availability of the materials themselves. For instance, in many locations, the low carbon version of stainless steel (304L, 316L, etc.) is the only form available. Owners and designers should not automatically specify their “home standards” without first checking material availability and pricing in the plant’s ultimate location.
  
  
• Complexity of controls systems/automation — The degree of automation must be evaluated early in the project’s life cycle to prevent catastrophic impact should the initial concept fail. In most international locations, “less is better.”

4. Procurement: Think locally, act globally