This webinar will outline a methodology for identifying and addressing different categories of BU and CU variation, including:
- Collecting and analyzing stratified BU and CU data per the International Society of Pharmaceutical Engineering (ISPE);
- Conducting a statistical analysis of the BU and CU data, including calculating the normality of the data, overall mean and RSD, location mean values, and within-location and between-location variation via an ANOVA;
- Identifying the category that accurately describes the BU and CU variation (e.g., trending, wandering, hot spot, scatter, stray);
- Analyzing potential next steps to further investigate the root cause(s) of the BU and CU variation for a given category of data; and
- Reviewing potential corrective actions to reduce the BU and CU variation, including a brief overview of the basic principles of segregation and powder flow.
Presenter Information: Jim Prescott joined Jenike & Johanson in 1992. His focus has been primarily on pharmaceutical applications, such as solving and preventing content uniformity problems, maintaining reliable feed, reducing product weight variations, developing specialized feeders for low feed rate/high accuracy applications, and standardizing handling equipment. He has published several articles, lectures frequently and has been awarded patents on equipment related to segregation testing and control. He is a member of American Association of Pharmaceutical Scientists (AAPS), International Society for Pharmaceutical Engineering (ISPE), and was a member of Product Quality Research Institute (PQRI) Blend Uniformity Working Group (BUWG).
Tom Baxter joined Jenike & Johanson in 1997. He has focused on pharmaceutical applications, including solving content uniformity problems, maintaining reliable feed and working with clients to develop more robust formulations and process designs, including the design and qualification of a continuous manufacturing process for oral solid dosages. He has published numerous papers, lectures frequently on the storage and flow of bulk solids and is a member of American Association of Pharmaceutical Scientists (AAPS). Tom also worked at Vertex Pharmaceuticals in the formulation development department as a Senior Scientist as part of a team designing, installing and qualifying on of the world’s first continuous tableting liens for oral solid dosages.
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