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[[File:Filtration Courses.jpg|thumb|right|Filtration Courses]] | |||
* | Filtration is used to separate unwanted contaminants, both viable and non-viable, from drug preparations.'''Filtration Course''' is intended to provide a fundamental understanding of biopharmaceutical filtrations and filters that will enable the participants to concentrate on the use of filters for the most demanding and critical operations for the manufacture of aseptic products. | ||
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* | This course will focus on: | ||
* | * Practical applications and experiences of filter usage | ||
* Economics and performance of systems designs | |||
* Definition of filter suitability in terms of structure and property relationships | |||
* Integrity test methods and importance | |||
* Process validation of filter devices | |||
Topics to be addressed include: | |||
* Filter manufacturing and construction of membrane and depth filters | |||
* Structural and design features of filters | |||
* Contaminant retention including mechanisms for liquid and gas filtrations; e.g., sieve retentions, adsorptive sequestration, electric double layer effect | |||
* Integrity testing including diffusional airflow, Bubble Point, pressure-hold and WIT | |||
* Validation requirements; e.g., bacterial challenges and viability, extractable testing | |||
* Troubleshooting | |||
==Who Should Attend== | |||
Personnel in manufacturing, regulatory affairs, validation, QA, and process development will benefit from this course. | |||
==Objectives== | |||
Upon completion of this course, you will be able to: | |||
* Apply knowledge of filter properties, including hydrophilic/hydrophobic, asymmetric/isomorphic and retention properties | |||
* Perform key filtration operations | |||
* Identify filterability and scalability requirements | |||
* Utilize sound judgment for filter selection | |||
* Describe validation and performance qualification | |||
* Differentiate and optimize filter arrangements | |||
* Design integrity tests and trouble shoot | |||