Modular Manufacturing: A Paradigm Shift for Pharma Plants

PharmaManufacturing.com

“Mod con” offers a number of benefits, but requires a different approach to planning and design

By William Smith, III, with Gordon Leichter and Pär Almhem, Pharmadule

Modular construction is becoming more popular for new pharmaceutical manufacturing facilities. The approach offers advantages such as improved quality, increased flexibility and faster completion, and allows owner-operators to minimize site disruptions and speed validation. However, modular projects must be handled very differently from traditional plant construction projects, and require a “paradigm shift” in both project planning and execution. This article will discuss some of the issues involved in designing and building new facilities using prebuilt modules.

Because these modules are assembled from thousands of parts in a parallel process similar to ship or aircraft assembly, the initial stages of any modular construction project are the most challenging and time-consuming. Assembly generally proceeds much faster—if initial planning and design have been carried out properly.

This emphasis on initial engineering means that a full engineering team is required at an early stage of any modular construction project. As a result, the modular project’s staffing curve is different from that of the traditional project, which typically starts with a core team, adding staff as the project progresses.

The timeframes for modular projects also tend to be much shorter than those for traditional engineering and construction projects. In addition, in modular projects, commissioning, qualification and validation are integrated, rather than sequential steps, as they are in traditional projects.

These differences between modular and traditional projects underscore the importance of initial design and planning stages in modular construction. Effective communication and coordination, both internally and

Figure 1

with engineering partners, is critical at the earliest stage of any modular construction project to prevent costly errors and redundancies.

Manufactured, Not Constructed

Today, a growing number of modular facility manufacturers, including Pharmadule, Jacobs, and Pharmaplan, offer different approaches to modular construction, bearing witness to a growing interest in the technology, the industry’s increased “comfort” with it, and increased engineering experience.

Modularization allows the more complex areas of a pharmaceutical manufacturing facility to be built in a controlled work environment, similar to the manufacturing of the complex equipment utilized in these facilities. The facility is assembled in a short time from parts and components that have been prepared in advance.

Large structural steel frames (modules) are the foundation of any modular project construction (Figure 1). These robust modules, complete with poured concrete floors, allow all architectural finishes, utilities, process piping and equipment to be installed before the units are transported to the final work site, without being taken apart (Figure 2). In addition, equipment installed within the module is placed in its final operating location, and won’t require reassembly or extensive retesting (Figure 3).

Master Planning for Modularization

Figure 2

Proper planning is important for any engineering project, but even more so with modular construction. A properly developed user requirements specification (URS) is invaluable as the basis for a successfully executed project. Validation must be considered in the initial phase of the project, as will be discussed later.

When deciding when to utilize modularization for a new plant construction project, the Construction Industry Institute (CII) suggests that the process begin at a Strategic Level I Analysis, where the benefits of modularization are aligned with business objectives. Subsequent steps then match project phases, to assure that proper information is available to evaluate the benefits of modularization and establish the proper sequence in the process, e.g.; URS development; evaluation of drivers, goals, objectives and barriers; comparison of alternatives; and levels of modularization and complexity [1].

The fast-track nature of a modular project requires a very concise set of project execution approaches that need to be considered in the early phases of project planning [2]. Team building, interface management, automation, and integrated
validation must be incorporated into the plan at the pre-project planning phase. Responsibilities for subcontractors, permitting, and interaction with site work all contribute to the efficacy of modularization. The accelerated pace of a compressed modularization schedule requires that all disciplines involved with the completion of the project are properly aligned.