Pre-Engineered Modular Cleanroom for High Containment Labs

Komal Hatti, IPS
Tim Rasmussen, G-CON Manufacturing Inc.

High containment labs are defined as research facilities with BSL-3, ABSL-3, BSL-4 or ABSL-4 classification per BMBL. A pre-engineered, turnkey and modular solution with pharmaceutical underpinnings is a safer, smarter and more sustainable approach for these complex facilities, as outlined below:

  1. Engineering and Construction Expertise: Engineering and construction expertise for low containment labs can be found easily. In contrast, there are very few qualified professionals with experience in high containment lab design and construction. A pre-engineered product removes geographical constraints and produces a superior quality product due to controlled construction environment.
  2. Standardized Design: High containment labs have mostly identical components. The only variation is size of the lab room itself. Following the principles of flex lab design and BMBL guidelines, a flex module can be easily developed that can grow in size and be flexible enough to receive most lab equipment.
  3. Pharmaceutical Design Philosophy: BMBL guidelines for high containment labs focus heavily on containment and decontamination. These exact concerns form the foundation for cGMP guidelines for pharmaceutical grade manufacturing facilities. A smarter approach therefore is to start the design with cleanroom and cGMP mindset and design team that has biosecurity and chemical engineering expertise, in addition to a typical AE team. On the other hand, most low containment labs are relatively large and require a designer with a good understanding of lean principles, process flows and mechanical systems for cross-contamination prevention.
  4. Validation Requirements: While failure of a mechanical system in a low containment lab will result in sample loss, productivity loss and minor illness, it will most certainly be fatal in case of a high containment lab. They require extensive post-construction testing and validation. Off-site validation of a modular, standardized product is easier and less expensive.
  5. Cost Neutral: Per square foot cost for a high containment lab is similar to that of a pharmaceutical clean room, and significantly higher than a typical lab. Small project size, complex engineering systems and lack of engineering and construction resources are to blame. Against this backdrop, a turnkey, pre-engineered, cleanroom product makes a lot of economic sense.

The presentation will demonstrate a product platform using a flex ABSL-3 module as the starting point. Components are added or subtracted to achieve variation in complexity for BSL-3, BSL-4 and ABSL-4 labs, while accommodating varying lab sizes.

Due to off-site construction, this approach has far a superior carbon impact compared to a traditional build.

Learning Objectives

  • Gain a better understanding of BMBL requirements for high containment labs. The presentation focuses exclusively on these four types of labs and uses BMBL guidelines as the basis of design for developing the flex modules;
  • Gain a better understanding of the concepts of containment and contamination. They will be better able to evaluate material, process and waste flows that are critical to the success of super clean facilities such as high containment labs and pharmaceutical manufacturing facilities;
  • Understand how modular clean room system works. The presentation uses an actual project design. This approach will open a discussion into what are the logistical challenges involved with accommodating and bringing in a large module inside an existing building; and
  • Gain a better understanding of architectural and engineering systems specific to high containment labs. These include finishes, walls, ceilings, door hardware, HEPA filtration, directional air flow, clean room electrical fixtures and devices, bio-kill system for waste, decontamination using autoclaves and special security systems.

Biography:

Komal has two decades of experience designing a range of building types for the pharmaceutical industry. She specializes in laboratories and research facilities, at an international scale. She has developed and implemented innovative concepts in modern laboratory designs. Her portfolio also includes pharmaceutical manufacturing, compounding pharmacies and vivariums.

Her background in technically complex projects, creative problem solving, leadership & management gives her a unique perspective.

Tim Rasmussen has 25 years' experience as a design and sales engineer across multiple disciplines from industrial manufacturing, aerospace, and medical device. In addition, Tim has experience as a commercial construction project manager. In his current role as a sales engineer for G-CON, he draws on his broad experience to assist companies in designing flexible and scalable autonomous cleanroom solutions.

 

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