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SGS has published an article on the working methodology to assess the exposure to pharmaceutics active principles in the November – December 2011 edition of Industria Farmacéutica magazine. Such bimonthly magazine publishes reports on pharmaceutics processes, biotechnology, research techniques, regulations, etc.

The article published in this pharmaceutics industry magazine, called “Exposure to API’s Assessment. Working Methodology”, describes the different phases to assess the exposure in the job environment to the pharmaceutics active principles (API’s). The described methodology is based in the available bibliography on the subject as well as SGS experience and technical expertise, which is divided into four different phases:

  • Classification of the dangerous active substances depending on their toxicological properties and pharmacological effects.
  • Definition of the necessary protection and contention measures.
  • Validation of the implemented contention systems or devices.
  • Evaluación de la exposición a principios activos mediante mediciones ambientales de los escenarios de exposición más significativos.

The proposed working methodology, based in the control banding philosophy, allows the definition, prior quantitative assessment, of the necessary protection and prevention measures destined for the control of the exposure, depending of the active substances that are being handled. The previous implementation of protection and prevention measures, as well as their later validation, allows facing the quantitative process with more possibilities of success and to confirm the acceptability of the exposure.

For more information, please contact:

Eva Dalmau
División de Prevención y Medio Ambiente
Técnico de Prevención
SGS Tecnos, S.A.
c/ Llull 95-97, 6ª planta
08005-  Barcelona
t: +34 93 320 36 33
m: +34 618 30 81 37
f: +34 93 320 36 31

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark in quality and integrity. With more than 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.