10 – Cleaning Validation


The cleaning of pharmaceutical equipment is an area of increasing  regulatory importance within the industry.  The potential for cross contamination of materials is influenced by a wide range of factors, and the achievement of robust and efficient cleaning operations offers a significant challenge to all product manufacturers. Effective cleaning is key to products assurance.  Cleaning is performed to remove product and non product-contaminating materials.  Ineffective cleaning can lead to adulterated product, which may be from previous batches, cleaning agents or other extraneous material introduced into, or generated by, the process.  Irrespective of the contamination source or facility configuration there is a need to ensure that cleaning procedures can cope with the demands of the task.  Cleaning validation is the means of confirming the reproducibility and efficiency of a cleaning procedure. This Monograph has been written by a team drawn from several of the leading UK pharmaceutical companies. It gives practical advice on a subject that is being actively discussed throughout the industry. This monograph is intended for all those involved in validating the cleaning of pharmaceutical equipment, whether they are employed in development, production or packaging. The first edition was published in 1999.


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