By William Smith, III, with Gordon Leichter and PÃ¤r 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
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
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 .
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 . 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.
Benefits of modularization are optimized at the initial design phase. While process architecture will drive the facility layout, the initial stages of design should take full advantage of modularization. The facility can be configured to optimize the positioning of process equipment, utilities, and walls within modules while also optimizing the equipment, material, and people flow of the complete facility. For example, process equipment and clean utilities are positioned within module boundaries, which means that entire systems can be assembled and pre-qualified under controlled workshop conditions.
Figure 4 exemplifies how a modular grid is applied to a combination primary and secondary production facility.
Planning for modularization at a project’s conceptual design phase will provide a layout that could be built conventionally if needed. To approach the project from the other direction by modularizing a layout designed only for conventional construction will require re-engineering costs and time delays associated with a respective redesign effort.
The accelerated pace of a modular project requires expeditious decision-making and communication processes. Long-lead equipment has to be specified and ordered at an early stage to avoid delays. One of the most critical aspects is to involve the quality organization in the initial review and approval process. The validation master plan (VMP) should be developed as early as possible in the project to provide the proper guidance during the compressed approval stages.
A thorough understanding of the communication expectations of modularization is needed. As the design moves through the stages of development, the approval plan becomes as critical as the fabrication schedule. Layers of approval and redundancy detract from the success of any modularization project. There will always be multiple parties involved in the complex process of delivering a pharmaceutical manufacturing facility. Alignment of the external resources is as paramount to attaining the efficacy of the modularization concept as are other disciplines involved.
Some of the time efficiency concepts of modularization should be thought of as akin to just-in-time (JIT) manufacturing. The core concept revolves around the proper and exact
- modules to the job-site,
- the foundation for the modules to sit on,
- plant utilities needed as services to the facility,
- or the acquiring of permits and local certification.
Logistics must be considered closely, and interfaces must be planned for and considered throughout the project.
Having a thorough understanding of the approval and communication process and the criticality of milestone decisions plays a very important part in executing the project. The best executed modularization projects are ones that provide early involvement of the respective disciplines that will commission and operate the facility—validation, maintenance, and end users—and an efficient approval process.
The reality of a compressed time schedule requires more discipline on the part of owners. The payoff, in addition to a shorter project timeline, is minimal changes in cost and schedule.
Changes are an inevitable part of any facility project. Considering the schedule compression and parallel activities that occur during modularization, the impact of late changes can be significant.
However, it is quite common that some processes are not completely defined until later in the project. These types of changes do not necessarily have a detrimental impact on modularization. Awareness of undefined aspects can allow for space and resources to be allocated during master planning. Furthermore, modularization allows for focus or deferral of respective undefined areas irrespective of other areas because modules can be built in any sequence.
When significant uncertainties exist, it may be better to delay manufacturing of the facility until a plan and necessary decisions are in place. Modularization can compensate for a delayed start and still have the facility online in time, with the assurance of a predictable cost and end date.
Avoiding Costly Redundancies
Master planning, facility programming, and process and architectural design should be performed with modularization in mind.
To avoid redundancies:
- plan early
- assemble the full team from the beginning
- assign clear roles, responsibilities and a clear organization
Owners must decide and specify equipment, finishes, etc. at an early stage or accept the standards used by the modular supplier.
To manufacture the modular facility, providers of modular facilities have to incorporate many of the same disciplines provided by traditional architectural and engineering firms in the planning and design of a facility. The most effective process is to design the modular plant directly, rather than performing all conventional design steps and then modularizing at a late stage. The organizations that recognize and eliminate this redundancy will benefit the most from modular technology.
Commissioning and Validation
Commissioning and validation of a new pharmaceutical facility should be considered the optimal goal, as the ROI is not realized until the facility can make product. Budgets and timelines usually become the target focus through a majority of traditional construction projects, sometimes leaving the commissioning and validation of the facility as the final area of focus .
Another paradigm shift that is realized with modularization is the incorporation of an integral commissioning and validation plan and execution program at the onset of the project. The manufacturing environment in which the facility is built and assembled is extremely conducive to quality assurance processes. These processes allow factory acceptance testing (FAT) not only of critical process equipment and the associated utilities, but also FAT of the respective equipment in the actual final location. This situation actually allows for a FAT of the entire manufacturing facility in a workshop environment.
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