(572g) Critical Process Parameter Determination for a Sterile Liquid Filled Syringe Product

An important consideration in the technology transfer of a sterile liquid into manufacturing is the determination of critical process parameters (CPPs). After the overall process flow is devised, the processing conditions for each individual unit operation can be determined. Process parameters, equipment capabilities, predicted operating ranges, critical operating limits, and the impact of exceeding critical limits are considered for each key unit operation. This paper demonstrates an example of the process review and assessment of the key process parameters for a new commercial sterile liquid filled syringe protein product.