Biometrix has extensive experience in the development and execution of high quality filling machine validation protocols. Biometrix can provide and execute filling machine validation protocols such as Installation, Operational and Performance Qualification. Biometrix can also develop filling machine specification documents such as Design, Factory Acceptance Testing and Functional and User Requirement Specifications.

Installation Qualification requirements will vary based on customer guidelines.  Operational Qualification will include SOP and training verification and manual/automatic control systems challenges. Performance Qualification will include determination of optimum operating parameters like conveyors and turn table speed, filling needle height, nitrogen flush rate/pressure, and a statistical confirmation of fill volume accuracy.  Media fills will be performed to challenge the range of container volumes and container opening sizes as well as transition to closure.

Biometrix provides consulting services to assist our clients with the often difficult task of developing and validating the sterilization of materials needed for a fill process and manipulation of sterilized filler parts at the start of a filling process and throughout the fill.

Biometrix provides a comprehensive validation report package that includes a summary of all test results including deviations, the executed protocol, test data, test equipment calibration data with NIST-traceable calibration certificates. The validation report package is carefully prepared, reviewed and submitted for client approval.

Our Validation Engineers have experience with a vast array of fill/finish processes and can provide you with the high quality service that you demand. Our ultimate goal is to leave you with the peace of mind that your company’s validation requirements are being met.

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