Renovating a facility requires careful design and a plan to minimize production interruption.
Not all types of construction are the same—there are significant differences between renovation and new or “greenfield” construction. Experienced construction professionals know that the design and renovation of a legacy facility is harder than starting from the clean slate of an unbuilt, green field. With new construction, because there are so few constraints, anything that is required (and within budget) can be provided. It’s a matter of having a clear definition of the user requirements, engaging in a systematic development of the design, and then executing the construction. Nearly as straightforward is stripping an existing facility down to the structural frame, sometimes referred to as “brownfield”. Again, except for the structure and its spatial constraints, everything is new. The only limits of what can be achieved are essentially practical and financial in nature.
A renovation, however, is by definition less intrusive, leaving much of the existing facility intact. Here the story is more complex. Although the new portions of a renovation are as straightforward as any other new construction, this new work does not stand in isolation. It is necessary for the new work to respond to and be integrated into the existing facility. A practical, cost-effective approach demands that existing systems and infrastructure be leveraged to the greatest advantage. This melding of old and new also presents an opportunity to address current problems and to extend the longevity of the existing infrastructure. In addition, it can facilitate the upgrading and change-out of obsolete systems.
The first step then is a systematic, thorough evaluation and inventory of the existing building and its utilities and services. Existing capacities must be identified, deficiencies enumerated, and strategies developed to address the infrastructure involved. But installed utilities usually are difficult to observe in their entirety and existing documentation is often inaccurate or, at times, non-existent. This limitation drives the design team to rely on experience to make judgements that will not be validated until the construction work is underway. A thoughtful strategy is needed to mediate the potential cost risks from these unknowns. A unique type of creativity, which grows out of experience and a knowledge of older systems and construction practices, is required.
With an in-depth understanding of the existing facility, the team can move forward with design. The requirements of the new design, however, must be superimposed on the existing, operating facility and its infrastructure. An assortment of tactics must be developed that reflects the specific conditions and circumstances of the individual systems involved. Some systems may be provided for the first time, while others will require refurbishment, extension, or replacement. Plans should be developed that optimize the value of the existing capital investment while delivering an effective operational installation.
The utilities required for the new portion of the facility is a case in point. Balancing the user needs and superimposing them on the existing limitations and opportunities of the facility is not easy. While providing as much new infrastructure as possible can simplify the design, leveraging the existing infrastructure is a powerful cost-savings tactic both in terms of first costs and ongoing operational expenses. Where to locate the new utility generation equipment is an important concern. Expanding an existing mechanical room has obvious advantages. But given the presence of existing ductwork and piping, the routing, coordination, and installation of services to support the new area is often a challenge. Careful location of the tie-in points is another related consideration. Where possible, finding appropriate tie-ins close to the area of work provides the best solution.
Besides its impact on initial costs and operations, achieving the chosen mix of new and existing will have a significant impact on the amount of manufacturing disruption required by implementation. With renovations, maintaining the ongoing operations (which is the source of revenue) is always an issue. Not only does the design need to integrate with the existing plant, but the new work has to be planned so that its execution minimizes interruption of the ongoing production activities. Phased construction is usually vital to attaining this end. Phasing can be broad and easy or it can be complex, requiring many successive construction stages. Regardless, the design has to support and facilitate the phasing strategy adopted. Working in these smaller construction components is by necessity less efficient than doing all the work at once. It is typically the best response, however, in order to maintain a facility’s ability to continue to make product during the construction phase.
In addition, the design has to reinforce the legacy facility and its current operations. Perhaps the most important consideration in this regard is maintaining, reinforcing, and expanding the flows for materials, equipment, personnel, and waste. Working in a GMP environment demands that compliance issues be embraced. It may be appealing to drop a new functional need into an existing open space, such as a warehouse, but this can be self-defeating. Any savings obtained by the easier execution will be wasted if overall GMP compliance is not maintained. Reinforcing and expanding the existing flows and gowning strategies is crucial to a successful facility that is sustainable for years to come.
Related to having and maintaining a clear system of process flows is anticipating future changes. Change is a constant in the pharmaceutical and biopharmaceutical industry, and a successful manufacturing facility will be called upon repeatedly to support any number of new products and processes. Any renovation work must keep open the ability to meet future opportunities. Appropriate access needs to be preserved so that new equipment can be moved into existing production spaces. Future expansion of the flow of material, personnel, and waste must not be excluded, and a plan should be in place to provide future space for expansions, even if it includes off-site scenarios.
Renovations are more complex and difficult to execute than new construction. There is greater complexity and creativity required to develop good solutions that do not detract from the existing or future operations. Integrating the new work into the existing infrastructure presents many challenges, but it is also an opportunity to exploit the capital already vested in the legacy facility. Facility managers should look at the constraints of existing infrastructure as resources that can be leveraged to great advantage and renovation as an opportunity to improve the entire facility.
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