Bioreactor Steam In Place (SIP) Practical
The goal of this practical is to prepare a 150L stainless steel bioreactor for a steam in place (SIP) cycle. Pressure hold tests are undertaken following a cycle of SIP, monitoring results and understanding processes involved.
Before the process is begun for bioprocessing, bioreactors are to be completely cleaned and sterilised to mitigate the risk of contamination that could potentially lead to complete product loss. The purpose of the PHT and SIP cycles is to maintain a sterile boundary in the bioreactor and ensure all systems are intact. Once the SIP cycles through the bioreactor components no other contaminants can enter. After bioreactor undergoes a CIP cycle a number of modulations are made so that the bioreactor is ready and capable of carrying out a PHT (pressure hold test) and SIP. The practical is make sure that students are competent in the processes involved in CIP, PHT and SIP and ensure that the sterile boundary is intact.
As per manual.
The changes to be made that were highlighted in the lab manual were undertaken and the PHT was performed. Potential leaks were identified following the PHT, requiring replacement of filter case and another PHT cycle. Following PHT confirmation, SIP was carried out. Discussion:
It is crucial to ensure that all of the components of the bioreactor required during the batch process are in place correctly during PHT and SIP as any further changes to the components will compromise the sterile boundary. As a result a further SIP cycle would have to take place. This means that all filters and probes (pH or oxygen) must be in place when PHT/SIP cycles are taking place.
The initial leak identified at the area where filters were installed indicated compromise of the sterility boundary. As the steam was able to leak from the boundary, it suggests that potential microbes and other contaminants may enter...
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