On Demand Webinar

The New EU GMP Annex 1 Revision 2017: Review, Insights, and Feedback

Learn more or

Download Now

Selección de los puntos de muestreo de partículas no viables más adecuados

MostSuitableSampPtLocationsAs environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).

The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the process being monitored.

The goal of this article is to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.

Particle counting in pharmaceutical applications can be clearly segregated into one of three categories: certification, qualification and monitoring. Each category requires a different approach.

Interested in learning more? Complete the form on this page to receive a free copy of the Choosing the Most Suitable Particle Sample Point Locations application note.

In order to provide complete functionality, this web site needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site including but not limited to: log in, buy products, see personalized content, switch between site cultures. It is recommended that you allow all cookies.