ASEPCO’s PolyMixer Cleaning Validation Study

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ASEPCO requested JM Hyde Consulting, Inc. to engineer and execute a CIP Validation study of the PolyMixer™.

Since 1993, JM Hyde Consulting has been a leader in providing value-added, expertise-based engineering, compliance, and validation services to biopharmaceutical and pharmaceutical manufacturers.

The plan includes the CIP cycle development of the CIP skid/circuit, generation and execution of one OQ protocol for the ASEPCO PolyMixer to show complete riboflavin removal, and the generation and execution of a PQ protocol to demonstrate repeatable, consistent CIP cleansing.

Registered users of ASEPCO Online may download the complete validation study. Log in to ASEPCO Online and scroll down to the Download section.