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    • A Complete Manufacturing Approach to Water Activity Monitoring A Complete Manufacturing Approach to Water Activity Monitoring Brady Carter, Research Scientist, Decagon Devices Recorded: Jan 11 2011 4:00 pm UTC 75 mins
    • A Complete Manufacturing Approach to Effective Water Activity Monitoring

      This seminar will provide information about strategies to control product consistency, quality and safety using water activity testing at key locations in a manufacturing facility. Strategies using water activity to facilitate product development and formulation in the R&D lab will be discussed. Applications for water activity in ensuring the quality and consistency of incoming ingredients at ingredient inspection also will be discussed. Information will be provided on ways for QA/QC departments to effectively use water activity as a release specification during production. Finally, strategies for determining shelf life and monitoring conditions while the product is stored in packaging and shipped to the consumer will be provided.

      Major Learning Objectives:

      1) Critical quality and safety factors that can be controlled by water activity

      2) How water activity can replace your moisture content specification

      3) Effective use of water activity:

      - in the R&D lab

      - for ingredient inspection

      - by QA/QC as a release specification

      - in storage and transport

      Brady Carter, MS is a Research Scientist at Decagon Devices, Inc. Before joining Decagon, he was an Assistant Research Scientist at Washington State University. Mr. Carter received his bachelor degree in Botany from Weber State University in 1997 and his master’s degree in Cereal Chemistry from Washington State University in 1999.

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    • Understanding and Applying USP Method <1112> Understanding and Applying USP Method <1112> Brady Carter, Research Scientist, Decagon Devices, Inc. Recorded: Sep 15 2009 3:00 pm UTC 76 mins
    • Understanding and Applying USP Method <1112>: Application of Water Activity Determination to Nonsterile Pharmaceutical Products


      This seminar will provide an overview of USP Method <1112> and how it can be used to save time and money. USP <1112> outlines strategies based on water activity that can reduce the amount of microbial limit testing needed for products with lower water activities. Microbial limit testing can be time consuming and expensive and reducing the amount of testing will result in savings. Products with water activity levels below the growth limits of pathogenic organisms are candidates for reduced microbial testing since the organisms cannot effectively grow under lower water activities. Utilization of this method requires an understanding of water activity and this seminar will define water activity and describe methods for accurately measuring it. The seminar also will discuss the relationship between water activity and microbial growth and discuss strategies for implementing USP <1112> to save time and money.

      5 Major Learning Objectives:

      What is water activity?
      How are water activity and moisture content different?
      How is water activity measured?
      What is USP method <1112>?
      How does USP method <1112> facilitate reduced microbial limit testing?
      How can USP method <1112> save time and money?

      Presenter:

      Brady Carter, Research Scientist

      Brady Carter, MS is a Research Scientist at Decagon Devices, Inc. Before joining Decagon, he was an Assistant Research Scientist at Washington State University. Mr. Carter received his bachelor degree in Botany from Weber State University in 1997 and his master’s degree in Cereal Chemistry from Washington State University in 1999.

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    • Dewpoint Moisture Content: A New Method Moisture Content Analysis Dewpoint Moisture Content: A New Method Moisture Content Analysis Brady Carter, Decagon Devices Recorded: Jun 8 2010 3:00 pm UTC 69 mins
    • Dewpoint Moisture Content: A New Method for Moisture Content Analysis

      This seminar will provide information about the Dewpoint Moisture Content method, a new method for moisture content analysis. Moisture content is a quantitative measurement of the amount of water in a product. It is primarily measured using loss on drying techniques where water (and often other volatiles) is driven out of the product by exposure to elevated temperatures inside an oven. Moisture content provides valuable information about yield, product purity, and ingredient concentration. Water activity represents the energy status of the water in the system. It provides valuable information about microbial, chemical, and physical stability. The primary method for measuring water activity is chilled-mirror dewpoint method. Moisture content and water activity are currently measured using separate techniques or instruments. The Dewpoint Moisture Content method makes it possible to measure both analyses in one instrument. To work, the Dewpoint Moisture Content method requires an understanding of the relationship between water activity and moisture content. This seminar will describe this relationship, called a moisture sorption isotherm, and how it can be used to determine moisture content using dewpoint derived water activity values. The accuracy and precision of the Dewpoint Moisture method will be reported and compared to other moisture content methods.

      5 Major Learning Objectives:

      1) The Dewpoint Moisture Content method will be introduced

      2) The relationship between water and moisture content will be described.

      3) Development of a calibration model relating moisture content to water activity will be described.

      4) Moisture content results for the Dewpoint Moisture Content method will be reported.

      5) The Dewpoint Moisture Content method will be compared to other methods.

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    • Incorporating Water Activity Testing in New Pharma Initiatives Incorporating Water Activity Testing in New Pharma Initiatives Brady Carter, Research Scientist – Decagon Devices Inc. Recorded: Apr 8 2010 3:00 pm UTC 81 mins
    • Incorporating Water Activity Testing in New Pharmaceutical Initiatives

      This seminar will provide an overview of effective utilization of water activity as part of new pharmaceutical initiatives such as ICH and QBD. USP 1112 outlines strategies based on water activity that can reduce the amount of microbial limit testing needed for products with lower water activities. These strategies can be applied to drug release quality programs that are developed using ICH or QBD guidelines. The primary goal of these initiatives is to create risk-based, science backed quality programs. In terms of microbial safety of drug products, the new quality initiatives indicate that products that are “dry” are candidates for reduced microbial limits testing. Water activity is the only effective screen for “dry” conditions that prevent microbial spoilage as evidenced in scientific literature while moisture content is not. Water activity is also related to other critical quality attributes such as dissolution, excipient performance, and degradation of API. Utilization of water activity testing requires an understanding of water activity and this seminar will define water activity and describe methods for accurately measuring it. The seminar also will discuss the relationship between water activity and critical quality attributes and discuss strategies for implementing water activity testing in drug quality programs.

      5 Major Learning Objectives:

      1) What is water activity?
      2)How are water activity and moisture content different?
      3)How is water activity measured?
      4)What critical quality attributes is water activity related to?
      5)How can water activity be used with ICH?
      6)How can water activity be used with QBD?

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    • A Complete Moisture Analysis A Complete Moisture Analysis Brady Carter Recorded: Jan 13 2010 4:00 pm UTC 85 mins
    • This seminar will highlight the importance of a complete moisture analysis consisting of both water activity and moisture content. Definitions for water activity and moisture content will be established with a particular focus on their differences. Methods for measuring water activity and moisture content as well as techniques for obtaining accurate measurements will be highlighted. The relationship between water activity and moisture content, referred to as a moisture sorption isotherm, will be described. Practical applications for water activity, moisture content, and moisture sorption isotherms will be detailed. These applications will cover both product safety and quality including: microbial safety, shelf life, ingredient mixing, temperature abuse, product formulation, caking and clumping, and package performance.

      5 Major Learning Objectives:

      1) What is water activity and moisture content?

      2) How are water activity and moisture content different?

      3) How are water activity and moisture content measured?

      4) What is a moisture sorption isotherm?

      5) How do water activity and moisture content influence product safety and quality?

      6) How can the relationships between moisture content and water activity be used to improve product formulation?

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