INSIGHTS: Proactive Planning for Improved Manufacturing

By Ryan Andrulewich, AIA, LEED AP BD+C

With our experience and focus on project outcomes, the team at Bergmann offers a specialized, proactive approach that helps our manufacturing clients address the unique issues that challenge their projects. These issues frequently include:

• Response to immediate market demand with minimal capital investment and limited downtime
• Unique flows and interactions of specific products (personnel, material, product, and waste) to comply with regulatory requirements of the market being served
• Implementation of project and future maintenance activities with minimal or no impacts to on-going operations
• Creating a facility that is cleanable and is a pleasant working environment for all employees

As architects, we are trained problem-solvers who seek design solutions that provide our clients with utility, structure, and beauty. We offer expertise that ultimately provides our clients with a facility that can cost-effectively expand to respond to their long-term business goals.

Whether our client is breaking into a new market or improving on established workflows, manufacturing projects are often phased for immediate market demand with minimal capital investments and downtime. In a specialized industry where cGMP compliant flows, systems, and processes are key drivers, near term goals must be rationalized against future market potential to minimize costly impacts associated with evolving business planning decisions. With our unique and specialized planning experience, we create responsive facilities that enable effective expansion opportunities that are aligned with their overall strategic vision.

Our approach begins with understanding the equipment and workflows and reviewing all steps of the process to understand the interactions and flows of personnel, material, product, and waste. All aspects of the process are examined to determine how they will flex and grow with business plans. One of our clients specializing in over-the-counter medications needed to improve raw material dispensing operations. After touring the plant to familiarize the team with site operations, the team designed an 8,500 SF central dispensing and wash facility to support a 325,000 SF manufacturing plant. Recipes were compared across multiple product lines and optimized to align common container sizes, weighing operations, kit building, and washing procedures. Our team paid particular attention to the efficient integration of clean equipment staging, kit building, and material weighing operations to minimize additional staffing needs. After centralizing dispensing operations, new SOPs (Standard Operating Procedures) were developed with the users to comply with product transfers through unclassified warehouse environments. We traced facility workflows and identified two product lines for additional improvements at point-of-use dispensing. Our team integrated with quality control departments from two vested companies to accommodate FDA and EU compliant qualification procedures, process validation, and information management. By following the process through every step, support operations were able to stay ahead of manufacturing schedules without a burden on existing manufacturing suites.

While movements within the manufacturing spaces are critical, Bergmann places equal importance on maintenance flows and utility distribution around the suite. The appropriate design is one that incorporates the logistics of implementation as well as maintenance. Qualified systems require detailed planning for expansion and efficient distributions. Headers and utility needs are rarely sized for grandiose master plans and all construction projects must account for future shutdowns and improvements with minimal impact to existing operations. In addition to offering 3D renderings for review with users, our team has provided clients with interactive fly-throughs of walkable ceilings, mezzanines, and equipment platforms. Details of shut-offs, disconnects, and reheat coil access are given the same scrutiny as a utility panel within the cleanroom. Our BIM enhancements allow clients to trace systems, perform clash detection, and develop strategies that minimize disruption to secure spaces by maintenance staff. For one contract manufacturing client, the design of a third expansion to a filling facility required fast problem solving when positive tests for lead paint presented constructability concerns. Our team modeled alternative structural solutions and coordinated in 3D in real time with the client and contractors to find a cost-effective solution to keep the project on track. These BIM models were provided to sub-contractors to expedite shop drawing development and submittal reviews. For clients whose business goals are driven by minimal downtime, time spent on a well-designed plenum has a direct impact on profitability.

Lastly, sterile facilities should not feel sterile. Manufacturing suites can be more than isolated labyrinths for employees who spend more hours at work than they do at home. The team at Bergmann is transforming outdated, whitewashed cleanrooms into modern facilities where architecture informs procedures and provides visual cues for workflow. After designing the master plan and completing a first phase of construction, Bergmann was retained by one of our start-up clients to complete a second expansion to accommodate rapid success in clinical trials. They allowed us to turn their manufacturing suite into a marketing tool that draws investors, partners, and colleagues. Simple ideas like using floor colors to represent gowning requirements, flows, and first aid stations help keep facilities safe and compliant. Visual connections and access to natural light allow for better communication, facility orientation, and employee productivity. The manufacturing spaces were able to highlight the modern, innovative culture of the company in a way that distinguished their reputation while respecting tight budgets.