In the 4th Quarter Edition of Technically Speaking, G-CON's Director of Engineering and Project Management, Mark Taylor discusses the execution, challenges and success of G-CON's first POD delivery in Europe and the collaborations that made it happen.

1. TECHNICALLY SPEAKING
G-CON Manufacturing, Inc. | Technically Speaking
Mark Taylor
Director of Engineering and Project Management
G-CON Manufacturing, Inc.
Delivery of the First POD to Europe...
Achieved with Flying Colors
Introduction
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) and McElroy
Associates (MEA). 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.
MEA’s long standing knowledge of structural and MEP systems
allowed G-CON to quickly drive the design forward to POD
fabrication and fit out. As customer specifications and
requirements expanded during the project, MEA was 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.
www.gconbio.com