Case Study
Cleaning Development and CIP PQ: Helped design the execution and testing strategy with a focus on the most difficult-to-clean locations. Wrote and executed the first cleaning development protocol. Provided execution and issue-resolution support, performed statistical analysis (including capability calculations using Minitab), and drafted the cleaning development report. Provided review and execution support for the CIP PQ.
SIP Development and PQ: Wrote and executed the SIP development protocol. Set thermocouple locations and sterile boundaries on the BFS P&ID drawing. Trained Technical Operations staff on using the Kaye Validator and installing biological indicators (BIs) into the BFS process piping. Provided review and execution support for the SIP PQ including data anlysis in Minitab.
Filling Design of Experiment (DoE): Focused on placebo temperature, filling pressure, and ampoule fill-weight stability. Developed the DoE in Minitab alongside the DoE protocol. Results provided process optimization for fill-weight control and temperature stability.
Filling Development: Optimized critical process parameters (CPPs) for filling. Performed capability analysis on development run data to establish CPP warning and alarm set points.
Process Development: Identified and set ranges for CPPs, including head and main mold temperatures, extrusion zone temperatures, mandrel cooling, filling pressure, and exterior cooling pressure of the ampoule card. Verified and optimized warning and fault limits with three additional placebo runs in preparation for BFS PQ.
Procedure Development: Drafted or updated BFS SOPs and work instructions to align with development data and new CPP ranges.
Personnel Training: Trained staff on BFS operations, ampoule fill-weight adjustment, and the use of Minitab for data analysis, including generating panels for validation reports.
BFS Equipment PQ: Wrote and led a team of 10 from Operations and Technical Operations to execute the BFS PQ, including one active product run and three placebo runs. Oversaw data collection and analysis, and drafted the PQ report with supporting graphs and statistical analysis.
Aseptic Process Simulation (Media Fill): Provided protocol review and technical support for three process simulation runs, drawing from experience in developing and executing three previous BFS aseptic process simulations.
Control Strategy Technical Summary: Authored a submission document outlining the strategy for maintaining CPPs within established ranges, summarizing development efforts, and provided analytical data to support the warning and fault limits.
PPQ Protocol and Report: Wrote and managed the execution of the PPQ protocol, which included three commercial batches carried out by Operations and Technical Operations. Drafted the PPQ report, generated Excel graphs and Minitab statistical analysis panels, and transitioned final report responsibilities to the Technical Operations team.