FAQ - Conteo de partículas en producción farmacéutica y ciencias de la vida

Pregunta
EU GMP Annex I was going to revise the acceptance criteria for Class A area (for non-viable particle count) from <1 to probable 10 or 20 particles. WHat is the status of this? Can you please inform wheter whether this has revisd and released or not? If not published then when it expected to be released.

Respuesta

The change to the revised limits was expected to be announced March/April 2007. However, we have yet to see confirmation of this from the regulators, so I'm afraid at this time I have no news.

The change from 1 to 20/m3 is also for certification purposes only and a different approach is required for monitoring the area. That approach is based upon the control of the environment you have, which is why it recommends data being gathered during media filling. This allows for a 100% testing of finished product and hence a close correlation of environment to finished product quality. It could be that the limit your facility deems acceptable is no more that 3 counts every 10 minutes and not necessarily 20 counts every 36 minutes.