The aim of this module is to identify and understand the many factors involved in the development, validation, implementation and control of cleaning programmes for the bio/pharmaceutical industry.
*Curricular information is subject to change
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Regulatory requirements for cleaning validation
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Cleaning design and development
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Cleaning Validation Programme
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Documentation requirements
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Lifecycle approach, Maintenance of the validated state/state of control
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Process Analytical Technology, Single Use Systems
-Equipment characteristics & design
-Types of cleaning
-Grouping methods & strategies
-Product/formulation attributes
-Residues/residue removal
-Sampling methods
-Analytical methods
-Limits
- Worst Cases
Lectures , Case-Studies, Workshops, Webinars, Literature Reviewo
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |