C&Q of SIP Cycles for Product Hold Vessels

The Aphex Group undertook a body of work to commission and qualify SIP cycles for a number of 2000L Product Hold Vessels for a protein based product. This was performed in accordance with the Project Validation Plan. Commissioning involved determining the potential worst case locations to heat up and cool down. Such areas were monitored using an Infra-Red based Heat Gun at various phases throughout the SIP recipe and completed cycles were analysed via the Pi Historian system. This allowed us to lengthen and shorten various timers for the individual phases as part of the SIP recipe. Extensive safety checks and a LOTO system were employed during this process. Understanding the various circuits and potential cross over with other commissioning activities was crucial in ensuring a safe work environment. Successful commissioning runs allowed for Functional Design Specifications to be redlined and updated to commence OQ and PQ. Due to the similarity of the routes between these vessels a family approach was adopted that allowed for reduced testing where a parent and child approach was adopted whereby the parent tank was run three times with temperature measured using a Kaye Validator 2000, along with BIs in worst case locations in each circuit, and a child circuit run once using the same acceptance criteria and testing methodology as the parent circuits.