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Implement or Expand Water Activity testing using USP<922>

Description

The USP <922> for water activity measurements became official on 01-May-2021 and multiple pharmaceutical companies are implementing or expanding the use of this new test. This General Chapter begins with the theoretical background of water activity, then a description of the five different types of water activity analyzers, and finally a description of the operation and validation of the water activity instruments and methods.

This webinar will describe how adding water activity measurements impact all the critical quality attributes of oral solid dose products including potency, purity, disintegration, dissolution, hardness, swelling and microbial growth. This webinar will explain why adding water activity measurements provides critical quality information that is not provided by Karl Fischer titration.

Water activity is a measurement of the chemical potential energy and therefore, the rate that water is available to participate in undesirable chemical, physical and biological processes. It is this concentration of free and loosely bound water that correlates to microbial growth, chemical degradation, and physical changes that can cause failures.
The webinar will include new information for formulation development, process development, and packaging development groups who must understand how moisture absorbs and desorbs during the manufacturing process and determines the water activity of the product at initial release.

We will focus on QC teams who manage and conduct the long-term stability testing of tablets and capsules in blister packs and bottles that are held at ICH Zone I to Zone IV or ICH accelerated stability conditions. See how water activity used is to determine the relative humidity inside the primary packaging versus time inside the environmental chamber. Learn how the moisture vapor transmission rate (MVTR) of the packaging as described in USP<671>, and actual moisture sorption properties of the drug product, impact the water activity of the product during the stability testing period.




Contributors

  • Mike Lally, Lighthouse Instruments

    Mike Lally is the Application & Validation Specialist at Lighthouse Instruments. For the past decade, Mike has worked with pharmaceutical research, manufacturing and QC groups who have implemented water activity testing into their quality programs. Prior to joining Lighthouse Instruments, Mike had 30-years of experience in analytical and preparative HPLC. Mike received this BS Chemical Engineering degree from Arizona State University.

September 15, 2022
Thu 12:30 PM EDT

Duration 1H 30M

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