G-CON

In this video, discover how G-CON partnered with NIIMBL on Project Blackhawk, transforming a 50-year-old warehouse into a GMP-like plasmid production facility using prefabricated POD® Cleanrooms. This innovative POD®-based approach integrated all utility systems, allowed renovation and construction to happen in parallel, and drastically accelerated the project timeline. The result: a demonstration of how GMP-capable facilities can be mobile, rapidly deployable, and adaptable even in minimal infrastructure environments. The project was supported with funding from the National Institute of Standards and Technology in the Department of Commerce under 70NANB21H085.

In this technical paper, Pete Makowenskyj, Sr. Director of Design Consulting at G-CON, explains how cleanroom facilities handling hazardous materials must balance patient safety, product sterility, and operator protection. The paper outlines the regulatory landscape, highlighting gaps between contamination-control guidance and containment requirements for high-risk agents such as ADCs, radiopharmaceuticals, and spore-forming organisms. It details key design considerations—including pressure schemes, HVAC zoning, filtration, and decontamination strategies—that ensure safe, compliant operations. The paper also emphasizes the value of prefabricated cleanroom solutions for achieving tighter environments, flexibility, and future-proofing.

The 503B outsourcing facility market operates under unique pressure: meeting FDA cGMP standards while maintaining agility, sterility assurance, and scalability to serve an ever-expanding network of hospitals, clinics, and health systems. As patient demand and regulatory oversight increase, traditional construction approaches struggle to keep pace. Prefabricated G-CON POD® Cleanrooms offer a transformative alternative—delivering speed, compliance, and future flexibility in a single integrated solution while also dramatically driving risk out of the project.

G-CON provided The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) with prefabricated POD® Cleanrooms to rapidly establish a GMP-like plasmid production facility within a renovated 50-year-old warehouse. The solution included prefabricated POD® Cleanrooms and all necessary utility systems, enabling parallel renovation and significantly accelerating the project timeline. The project was supported with funding from the National Institute of Standards and Technology in the Department of Commerce under 70NANB21H085.

Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.

In this case study, learn how TrueBinding leveraged G-CON’s prefabricated cleanroom PODs to achieve their mission critical goals.

In this webcast, we review industry drivers and risks for capital construction, with a focus on cleanroom infrastructure, and discuss the goals of using a hybrid approach while demonstrating its application and benefits using real-world examples.

Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.

G-CON’s floorlessPOD is a free-standing structure that provides direct integration with the host facility floor, eliminating the need for ramps, platforms and stairs typically required with prefabricated structures that have integrated floors. With fully integrated MEP, the floorlessPOD is an ideal solution when the cleanroom cannot be structurally supported by the host facility.

Following project close out, the G-CON Service Team will ensure that your PODs continue to function as intended. Service offerings include preventative maintenance plans, spare parts, NEBB certified TAB services (testing, adjusting, and balancing), and expedited support options. Additionally, the Service Team handles all warranty requests and manages data from these activities to drive continuous improvement in our products’ performance across all aspects.

Learn about the customization of cleanroom doors to meet specific operational and design requirements. This paper highlights GCS's ability to tailor door solutions, ensuring seamless integration with existing cleanroom infrastructure while maintaining efficiency, sterility, and compliance with industry standards. With a commitment to quality, compliance, and efficiency, GCS delivers door solutions designed to enhance cleanroom performance and meet the stringent demands of controlled environments.

GCS manufactures cleanroom components designed for critical environments, prioritizing the use of sustainable and responsible materials, without compromising the quality and performance of our products. GCS, with its broad range of highly innovative products for the cleanroom infrastructure market, provides clients access to premium cleanroom materials such as modular wall and ceiling panels, cleanroom and specialty doors and other unique components.

G-CON’s floorlessPOD is a free-standing structure that provides direct integration with the host facility floor, eliminating the need for ramps, platforms and stairs typically required with prefabricated structures that have integrated floors. With fully integrated MEP, the floorlessPOD is an ideal solution when the cleanroom cannot be structurally supported by the host facility.

Combining on- and off-site construction approaches reduces project risk while offering benefits to schedule, flexibility, and cost of ownership for new cleanroom construction.

Webinar Date/Time: Thu, Nov 14, 2024 11:00 AM EST

Prefabricated modular construction has gained momentum in many industries around the globe. However, traditionalists continue to have concern and resist adoption of this approach.