El control total de la contaminación en Salas Blancas y Estériles

How to Succeed in the Search for Nothing: Effective Swabbing Techniques for Cleaning Validation

Searching for nothing would seem to be an absolute waste of time — unless you are responsible for cleaning validation. In that case, success is deliciously ironic since you can say, “I found nothing and that’s good news”.

Introduction

Searching for nothing would seem to be an absolute waste of time — unless you are responsible for cleaning validation. In that case, success is deliciously ironic since you can say, “I found nothing and that’s good news”.

But perhaps we should start at the beginning.

Those involved in the manufacture and quality control of pharmaceuticals and biotechnology products are aware of the need to prove that the production equipment and the manufacturing environment are sufficiently clean such that the next lot of product will not be contaminated by materials from the previous lot, i.e. that cross contamination will not be an issue. The
procedures and documentation for that proof constitute what is known as cleaning validation. Essentially, one wants to prove with a high degree of certainty, that any residues of drug product from a manufacturing lot and any residues of cleaning agents used to remove those drug residues, are below acceptable limits. To put a fine point on it, we’re not exactly searching for nothing (as in a zero value), but for extremely low values of residues — both drug product residues and cleaning agent residues.

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