ACTIVE AND PASSIVE AIR SAMPLE ACCORDING TO GMP Annex 1
Alessandro Ligugnana
Environmental Monitoring and Contamination Control for the Pharmaceutical Industry @ ORUM INTERNATIONAL
ACTIVE AND PASSIVE AIR SAMPLE ACCORDING TO GMP Annex 1
Continuous monitoring with active or passive air sampling?
The GMP Annex 1 introduced news about the microbial air monitoring in Grade “A” and “B” of the cleanroom.
The paragraph 9.22 of the Chapter 9 says:
The paragraph 9.24 of the Chapter 9 says:
It is clear that both active and passive methods for continuous monitoring are considered valid and should be together applied.
Active and Passive microbial air sampler together
The combination of an active and passive sampling systems is the answer to the GMP Annex 1: both methods should be applied.
TRIO.BAS AIRBIO TRIO (25 l/m) for Active Air Sampling
TRIO.BAS ISOLATOR RABS (25 l/m) for Active Air Sampling
TRIO.BAS TRIO SETTLE FOR TABLE” with timer for Passive Air Sampling
All the two procedures are under control with “TRIO.BAS? ISOLATOR RABS (25 l/m)” (or AIRBIO TRIO (25 l/m) connected to one or two or three satellites) stationary air sampler in combination with the TRIO.BAS COUNT DOWN SETTLE. The operator performs active and passive sampling with the same air sampler and the related data are recorded.?
The data are recorded in the memory of the air sampler and it is possible to export them to a printer.
It is possible a continuous air sampling from 1 to 6 hours using 1 or 2 or 3 plates. The use of 2 or 3 plates reduces the dehydration of the nutrient agar medium with better fertility for the growing of microorganisms. Another important advantage is that during the working shift it is easy the identification of time when a microbial contamination happens.
With the TRIO.BAS ISOLATOR RABS it is possible to easily install satellites in different critical points.