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Cleaning Validation - Dismissing Your Fears

The term 'cleaning validation' has been known to make grown men cry, or at least shake with fear! It is a much misunderstood process yet can be relatively straightforward if tackled correctly and methodically. Cleaning validation can be defined as 'documented evidence that has a high level of assurance, where a cleaning process will consistently produce equipment and products meeting pre-determined quality specifications.' There are many approaches to establishing a rugged, documented, validated cleaning programme. Here we will discuss just one option of approaching cleaning validation in a systematic way, to achieve the final cleaning goal.

Step 1

In this initial step, there are four tasks to accomplish before being able to move to Step 2.

1. Identify and keep a record of all manufacturing and filling equipment, which is dedicated to one product or used for multiple products. Equipment used for multiple products may be considered (provided it is qualified) for product grouping as an alternative to individually validating all the products processed with the same equipment. Similarly constructed equipment is defined as having a different size, but built with the same material of construction when compared to the equipment train in the specific group.


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By Phil Smith, Marketing Manager at STERIS - Life Sciences Group

Phil Smith is a Marketing Manager for STERIS - Life Sciences Group, focussing on the cleaning and disinfection of validated pharmaceutical environments within Europe, the Middle East and Africa. Originally qualified in Microbiology and Biochemistry, he has worked in regulated industries for 13 years. His career began in sterility assurance, and later biocide development. Phil also has a wide experience of health care and pharmaceutical processes and has held positions in sales, business development and marketing. For the last six years, Phil has focussed on cleaning validation for STERIS, becoming involved in international 'clean in place' (CIP) projects and broader cleaning validation issues.

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