Cleaning Validation References – Alconox


Cleaning validation is a necessary and time-consuming part of manufacturing
pharmaceuticals. The validation process can be expedited and the cost reduced if the
cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to
market faster and at a lower cost. This paper outlines the basics of cleaning validation
and discusses the support services you should seek from your critical cleaning
products supplier to optimize your cleaning validation process.

A cleaning validation involves testing for accept able
residues on pharmaceutical manufacturing or medical
device surfaces. The validation involves:
• Residue identifi cation
• Residue detection method selection
• Sampling method selection
• Setting residue acceptance criteria
• Methods validation and recovery studies
• Writing a procedure and training operators
This procedure is used to document acceptable residues 3 or more times and then a rational monitoring program to maintain a validated state is put in place. If you are changing any part of your procedure or cleaner, first clean the new way, collect data and then clean the old way before using any equipment while you are in the
process of validating the new procedure. 2018-02-09 08-21-28-245

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