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Kimball Shahrokhi
Introduction
Renovating an existing pharmaceutical manufacturing facility is a complex process that demands detailed planning to balance compliance, operational efficiency, and safety. Many design considerations need to be addressed when renovating an existing process area, but especially when repurposing non-manufacturing areas into new process spaces. A successful renovation requires thoughtful design to not only ensure the facility meets the latest regulatory standards, but also boosts productivity, fosters innovation, and maintains the highest degree of safety for both workers and products. This article explores key design elements that must be considered when renovating pharmaceutical manufacturing spaces to help achieve a seamless and effective pharmaceutical manufacturing facility renovation.
Renovation Considerations
Space Planning
Effective space planning is a key early component to every successful renovation project. Designers must begin with identifying the criteria required to support the future process, including:
- A comprehensive list of process equipment, including fixed and portable
- Material and waste handling requirements
- Personnel flow
- User Requirement Specification (URS)
This planning phase should be a collaborative, iterative process involving the design-build team and owner representatives, including operations, quality, facilities, and other relevant groups. The result will yield an area layout aligning with the planned manufacturing process that optimizes material, personnel, and waste flows.
For renovations, it’s crucial to account for adjacent spaces and their future interactions. Opportunities must be considered for shared gowning areas and should assess how the material, personnel, and waste flows will interact to maximize space efficiency, minimize operational risk, and ensure GMP compliance.
Ideally, a User Requirement Specification (URS) is completed before the planning process begins, as it will provide essential insights into operational requirements that may impact space and adjacency requirements. In reality, the URS is frequently developed in concert with the early design effort.
Floor-to-Floor Height
Manufacturing cleanrooms require more vertical height than non-classified support spaces. Core cleanroom height requirements are typically based on the associated process equipment, including equipment height and maintenance/operational access requirements. Above the cleanroom ceiling, additional height is required for the ceiling structure, HEPA housings, ductwork, utility piping, lights, electrical/controls conduit, sprinkler piping, and building steel.
For renovated spaces, it is ideal to first completely remove all existing systems to provide maximum flexibility for the new cleanroom design. However, this is often impractical as some existing systems may need to remain in place and accommodated by the new design. The most effective approach to address these constraints begins with an early demolition effort, removing all feasible elements. Following this, a laser scan of the remaining space should be conducted to accurately document initial conditions and provide the design team with a clear foundation and path forward for planning.
Mechanical / Electrical Spaces
Supporting manufacturing cleanrooms requires careful planning of mechanical and electrical spaces. In some cases, existing support spaces can be repurposed to house necessary equipment, especially if systems from previous operations can be adapted to meet future operational needs. When addressing ducted systems and new space is required, it is important to prioritize spaces adjacent to or near the cleanroom(s) to minimize required runs of extensive ductwork.
Electrical and control panels should be located relatively close to process equipment for accessibility and efficiency, while the power source can remain farther away, often housed in an existing electrical room. Accessibility, whether from inside or outside the cleanroom, must also be considered for non-classified space requirements associated with specific process equipment (e.g., sterilizers, etc.), based on operational needs.
Access to Building Exterior
Manufacturing cleanrooms often require some degree of access to the building exterior and, in some cases, the roof. This access is necessary for features such as exhaust ducts and/or process/relief vents. If HVAC equipment is located outdoors, provisions must be made for large supply and return ductwork.
In multi-story buildings, effective vertical connectivity must be ensured in the form of chases or other pathways. This can be particularly challenging when the renovated space is on a lower level with normal operations continuing on the floors above during construction.
Utilities
Utility requirements for manufacturing spaces vary substantially. Designers must begin by assessing the availability of essential services such as domestic water, sanitary and process waste, and power. Next, process and plant utilities, such as chilled water, plant steam, and compressed air should be evaluated to determine their ability to support the planned future operations. If additional capacity is needed, expanding utility generation by integrating it with existing utility systems is the most ideal approach, if possible, to maximize overall system efficiency and redundancy.
Repurposing non-manufacturing areas frequently yields greater challenges as these areas often lack the required utility capacities. However, these limitations can be addressed through an engineering evaluation. If feasible, new utility services can be brought into the building or area.
Conclusion
Pharmaceutical manufacturing facility renovations involve navigating a complex array of challenges due to numerous factors that must be considered. From space planning to utility capacity, achieving success requires balancing the specific needs of the new space within the constraints of an existing facility. The success of such undertakings hinges not only on meticulous planning and execution but, more importantly, on the selection of a design-build partner equipped with the requisite expertise, experience, and approach. This is where BE&K Building Group stands apart.
BE&K Building Group brings to the table a deep understanding of the pharmaceutical manufacturing sector, augmented by a rich history of delivering complex renovation projects on time and within budget. Our team integrates seamlessly with clients and embraces a collaborative approach from the outset to ensure every aspect of the project—from initial concept to project completion—aligns with both current and future operational needs. Our adherence to quality, safety, and the latest regulatory standards, combined with our innovative use of technology, such as laser scanning for precise conditions mapping, ensures we overcome physical constraints while optimizing manufacturing processes.
Moreover, our expertise in innovative space planning, mechanical and electrical space configuration, and the strategic integration of utility services, positions BE&K Building Group as the quintessential partner for navigating the many challenges inherent in pharmaceutical facility renovations. Our track record of transforming challenging spaces into compliant, efficient, and safe manufacturing environments attests to our capability to exceed client expectations.
Choose BE&K Building Group for your next pharmaceutical manufacturing facility renovation project. Together, we can create spaces that foster innovation, elevate productivity, and maintain the stringent levels of safety and compliance required in the pharmaceutical industry.
Contact us today to embark on a journey towards transforming your vision into reality. Let’s build the future of pharmaceutical manufacturing together.