LG Life Sciences, the technology and electronics innovator, had a project awarded to manufacture large quantities of the polio and pertussis vaccines. To accommodate the work, LG Life Sciences was required to build a biologics manufacturing facility that incorporated both cGMP and BSL-3 design concepts. The large-scale production containment facility is the first documented design of its kind. CRC was selected to consult on the detailed design for this highly complex facility and certify its operations per NIH/CDC and applicable country requirements.
The principle of GMP design requires production to be conducted in a positive pressure setting so that the material can be contained. Alternatively, BSL-3 laboratory design principle requires negative room pressure so that there is no cross-contamination from room to room. The design of the facility required a BSL-3 laboratory within the GMP facility. CRC reviewed the 100% detailed design document and recommended the air pressure regime for BSL-3 and GMP. Challenged with not changing the layout (i.e. location of door) per LG Life Science’s specific requirement, CRC assigned pressure differential zones. Upon review of the HVAC design, CRC recognized that some parts of the system were under-engineered while other parts were over-engineered. Since the HVAC design could not be changed due to budget restraints, CRC recommended using an air leakage test to verify the proper HVAC performance.
CRC has been providing periodic construction inspections as part of its consultancy role. One deficiency identified by our biocontainment engineers was a poorly installed paneling system. CRC identified that the joints did not meet properly. Additionally the industry-standard laminate was missing. This issue was immediately brought to LG Life Science’s attention. Upon construction completion, CRC returned to certify the facility.