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WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation
(2006; 43 pages)
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View the documentSupplementary Training Modules on Good Manufacturing Practice
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View the documentBasic Principles of GMP
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Validation

Direct surface sampling (direct method) (2)

  • Other factors include:

    - location from which the sample is taken (including worst case locations, identified in the protocol)

    - composition of the equipment (e.g. glass or steel)

  • Critical areas (hardest to clean)

    - e.g. in semi-automatic/fully automatic clean-in-place systems

  • Use appropriate sampling medium and solvent

9.2.2 The location from which the sample is taken should take into consideration the composition of the equipment (e.g. glass or steel) and the location (e.g. blades, tank walls or fittings). Worst case locations should be considered. The protocol should identify the sampling locations.

9.2.3 Critical areas, i.e. those hardest to clean, should be identified, particularly in large systems that employ semi-automatic or fully automatic clean-in-place systems.

9.2.4 The sampling medium and solvent used should be appropriate to the task.

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Last updated: May 3, 2013