El control total de la contaminación en Salas Blancas y Estériles

Optimum Wiper Characteristics for the Cleaning and Disinfection of Pharmaceutical Cleanrooms

Who knew that there was so much technology associated with such a small piece of cloth?

Introduction

The title of this presentation, while perhaps not generating breathless excitement, does deal with an important topic. The cleaning and disinfection of pharmaceutical and biotechnology cleanrooms - especially aseptic fill areas - are critical, “no compromise” activities. These important tasks are scheduled to occur between sequential manufacturing lots; in fact subsequent lots cannot be manufactured until the manufacturing equipment and the environment have been cleaned and disinfected and the cleaning activity has been validated. Wipers - and by extension, mops - are used for these cleaning and validation tasks and since they come into contact with critical manufacturing surfaces, it is important to understand which materials are optimum for these activities. We want these procedures to be done efficiently, without undue labor, in a reasonable amount of time and with the assurance that the treated surfaces have been effectively cleaned and disinfected. If we examine the cleaning and disinfection activities needed for pharmaceutical cleanrooms, we can readily identify a number of key characteristics for wipers and mops.

  • Optimum Wiper Characteristics
  • Form Factors
  • Sterility
  • Cleaning
  • Disinfection
  • Optimum Wiping Techniques
  • Sterile Pre-wetted Wipers

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