Delivery of the First POD to Europe... Achieved with Flying Colors

Mark Taylor, Director of Engineering and Project Management

In late 2018, G-CON began working with a global pharmaceutical company whose goal was to scale up their manufacturing operations in the US and Europe for an approved CAR-T product. Specifically, the client was establishing internal lentivirus production capabilities, starting with a fast-track clinical facility at the one of their existing sites. In addition to the demand for clinical capabilities, a 200L commercial operation was also required. Both projects were schedule driven. The client chose G-CON’s POD technology for the clinical portion due to its higher probability of success in schedule driven projects.

Project Execution

To ensure project success in this new market, G-CON enlisted the help of the Asgard Cleanroom Solutions (Asgard). Asgard, G-CON’s European supplier, is the leading installer of architectural cleanroom components in Europe. MEA is an engineering firm located in Dublin, has over 28 years’ experience supporting the pharmaceutical cleanroom industry in Europe.

Asgard’s main objective/role was organizing the manufacturing support to fabricate PODs for the European market. Their expertise in architectural cleanroom systems and relationships with other MEP installers ensured that G-CON provided their customer with the highest quality components without increasing the overall project cost.

With our partnership with IPS through the iCON facility platform, G-CON was able to quickly drive the design forward to POD fabrication and fit out. As customer specifications and requirements expanded during the project, teams were able to quickly adapt and update critical design elements without delaying POD progress.

Project Challenges

In addition to being the first POD system G-CON has successfully manufactured and installed at a client’s site in Europe, this project presented several challenges that G-CON had not previously faced:

  • This was the first POD system to be installed on the 5th floor of a customer facility (with no additional landing) requiring the use of multiple cranes to lift the PODs in place. The use of a second crane provided stabilization so that the rigging points of the first crane could be safely removed as the PODs entered the opening.
  • The truck staging area where PODs were lifted by cranes was on a severe and unavoidable slope. In addition, there was only single lane access where the PODs were rigged and lifted off the trailers. After each trailer was set in place, an engineered ramp had to be assembled so that the trucks could back on to it. Utilizing the ramps and by making adjustments to the trucks air suspension, the PODs were able to be leveled prior to their removal from the trailers.
  • The balcony at the POD entrance was unable to take on additional loading. Working with the onsite construction team, arrangements were made to add the final finished surface to the balcony once the PODs were in place. This offset height was calculated with an understanding of how far the PODs could enter the building prior to removing their first rigging point in conjunction with the POD overhead clearance.
  • The clearance dimensions around the PODs totaled 125 mm (approximately 5 inches) both vertically and horizontally (75mm on each side of the final SubPOD).
  • The local work force spoke German. The overall clearance between the host facilities floors limited access to the top of the PODs requiring a different approach to plenum access.

Meeting Customer Needs

Through diligent planning and precision execution, G-CON was able to deliver this POD system on time and within budget without sacrificing any of G-CON’s stringent quality and safety requirements. Once again, G-CON’s met its true measurement of success, meeting customer needs so that all parties can focus on what really matters, the patient.