Airbio One for continous monitoring
853K AIRBIO ONE CM 25 l/m PETRI with cable PACK (25 litres/min flow rate) (*)
(*) each PACK consists of: 1 air sampler with Bluetooth and battery charger, 1 calibration certificate, 1 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable for transfer data and 1 robustus carrying case.
The GMP Annex 1 introduced news about the microbial air monitoring in Grade “A” and “B” of the cleanroom:
The paragraphs 9.22 and 9.24 of the Chapter 9 say:
9.22 Where aseptic operations are performed, microbial monitoring should be frequent using a combination of methods such as settle plates, volumetric air sampling, glove, gown and surface sampling (e.g. swabs and contact plates). The method of sampling used should @e justified within the CCS and should be demonstrated not to have a detrimental impact on grade A and B airflow patterns. Cleanroom and equipment surfaces should be monitored at the end of an operation.
9.24 Continuous viable air monitoring in grade A (e.g. air sampling or settle plates) should be undertaken for the full duration of critical processing, including equipment (aseptic set-up) assembly and critical processing. A similar approach should be considered for grade B cleanrooms based on the risk of impact on the aseptic processing. The monitoring should be performed in such a way that all interventions, transient events and any system deterioration would be captured and any risk caused by interventions of the monitoring operations is avoided.
The new generation of ORUM microbial air samplers called "CM" have been developed to follow these new indications of GMP Annex 1.