Molecular Weight Test Method Validation and HPLC System Qualification

Abstract

The Molecular Weight (Mw) Test Method is performed by a contract laboratory. Performing the method externally affects the product release timeframe and represents additional costs when the results are required to be expedite. It is the intent of the company to validate the Molecular Weight (in-house testing) to avoid the waiting time associated to the samples travel time and to the test processing lead time. Qualifying this test in-house will allow to process results in three days instead of two weeks (current timeframe for contract laboratory to provide the results upon processing). There will not be associated costs to expedite results once the test is qualified at the company laboratory. Additionally, the company will be implementing a data acquisition software (Empower) which will allow the automatic processing of the samples as well as the results to avoid data transcription. Empower software is FDA 21 Part 11 compliance fully traceable through an audit trail configuration. This feature will avoid security opportunities (data manipulation). Key Terms ⎯ Molecular Weight, P4HB monofilament, HPLC System, Bioresorbable material.