Characterization, Standard Operating Procedure and Validation Document Generation of the Flexicon PF7 for Reagent Fill Manufacturing

This Semester-in-Residence project was conducted at lllumina, Inc., HQ in San Diego, CA between the manufacturing and pilot plant departments. The intent of this Semester-in-Residence project was to complete characterization activities related to the Flexicon PF7 Filler, and generate User Requirement Specifications (URS), Standard Operating Procedures (SOP), and Installation Operational Qualification (IOQ) documentation for the validation of the Flexicon PF7 Filler. One of the requirements under current good manufacturing practices (cGMP) is to validate manufacturing equipment to ensure the equipment operates and is appropriate for the intended use. A URS, SOP, and IOQ documentation were generated in order to validate the Flexicon PF7 Filler. The purpose of the URS is to layout the minimum requirements that the Flexicon PF7 Filler must have in order to meet the intended use in Reagent Manufacturing. The SOP was created to provide the specific details needed to properly operate the equipment so that it operates as intended. The IOQ protocol is required in order to verify that the minimum installation and operational requirements of the Flexicon PF7 are met with regards to the URS. All validation related documents, the URS, SOP, and IOQ were successfully created and approved. The characterization study was completed and is going under review. The characterization study outputs will serve as inputs to the performance qualification (PQ) that will be executed after the IOQ is successfully executed. Future recommendations are to characterize the effects of liquid surface tension with relation to dispense volume.