The system FAT was a three-week test SBBI conducted to verify the fabrication and functionality of the bioreactor systems.
Members of the Cytovance team traveled to Bethlehem, PA for the duration of the FAT to supervise and observe the process.
Two problems initially threatened to delay the FAT process for the 500 L bioreactor system. First, the vessel arrived from
the manufacturer with shipping damage. Second, there were difficulties in ensuring that all the 500 L agitator impellors were
delivered in time.
Cytovance Biologics and SBBI worked creatively to avoid delays and keep the project on schedule. The shipping damage to the
500 L vessel consisted of a dent to the vessel jacket, requiring jacket replacement. Functionally, this did not affect any
of the FAT tests, so we first decided to continue with the FAT and repair the vessel after testing. It was more economical
time-wise to ship the vessel from Pennsylvania to Missouri (where it could be turned around in less than one day) on its way
to Oklahoma, rather than delay the FAT schedule.
Second, we decided that having all agitator impellors installed was not functionally important for most of the FAT execution.
The second impellor that SBBI was waiting to receive was required only for the riboflavin and sterile media hold challenges.
This allowed SBBI to continue testing the 500 L system for one-and-a-half weeks before the last impellor arrived, which preserved
the original schedule.
The system FAT proved to be a critical test. By performing an extremely thorough inspection of system fabrication and functionality,
non-conformances that were found could be corrected on site at the SBBI manufacturing facility. Various flaws in the programming,
piping slopes, and CIP flow paths were easily addressed during the FAT process.
Additionally, Cytovance Biologics had also ordered a CIP skid that was ready for testing at the same time as the bioreactor
systems. This enabled us to test the communication between the CIP skid and each bioreactor system during the FAT and verify
that the systems communicated as designed.
At the end of the FAT, we developed a formal list of action items required to be addressed before shipment. The FAT was successful
in ensuring that Cytovance Biologics received functionally sound bioreactor systems that were fabricated according to approved
specifications and documented any nonconformances that were found.
INSTALLATION AND START-UP
The 100 L bioreactor system arrived on site at our facilities in Oklahoma City on March 20. The 500 L bioreactor system arrived
on March 27 and the vessel followed closely behind (after stopping through Missouri for the jacket repair). SBBI was scheduled
for two visits to complete the project: the first for installation of the bioreactor system and the second for system start-up
Cytovance Biologics rapidly executed system set-up and tie-in to the utility systems in each cell-culture suite, to allow
SBBI to perform their installation functions on time. The installation included reassembly of the bioreactor systems, leveling
of each system, and assurance that the vessels were correctly mounted on the load cells .
SBBI returned for the second visit two weeks later to perform system start-up training. SBBI provided instruction on operation
of the DCU3 controller, performed some system checks, and tested sequences.
When SBBI completed the formal installation and start-up training, Cytovance was ready to begin formal commissioning and qualification
of the bioreactor systems. The 100 L and 500 L bioreactor systems had been ordered, fabricated, delivered, and installed successfully
on time and on budget.
This project represented hard work, successful planning, and creative solutions from the entire bioreactor project team. When
managing a large project, there are certain guidelines a project manager should implement to ensure the project goes as smoothly
User Requirement Specification (URS) Time constraints meant that a formal URS was not generated as part of this project. However, we highly recommend developing
a formal URS. This document defines detailed specifications of what the user requires for a piece of equipment, or a system,
and includes piping, instrument, and software control requirements. The URS is then submitted to vendors to solicit proposals
for systems that meet user requirements.