Continuous Air Microbial Monitoring

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.
AIRBIO ONE CM
IDENTIFICATION CODES
Code | AIRBIO ONE for CONTINUOUS 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


AIRBIO DUO CM
IDENTIFICATION CODES
Code | AIRBIO DUO for CONTINUOUS MONITORING |
---|---|
854K | AIRBIO DUO 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, 2 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable for transfer data and 1 robustus carrying case
AIRBIO TRIO CM
IDENTIFICATION CODES
Code | AIRBIO TRIO for CONTINUOUS MONITORING |
---|---|
855K | AIRBIO TRIO 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, 3 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable for transfer data and 1 robustus carrying case

TRIO.BAS RABS ISOLATOR CM AND SATELLITE CM
IDENTIFICATION CODES
Code | RABS ISOLATOR for CONTINUOUS MONITORING |
---|---|
850K | TRIO.BAS RABS ISOLATOR CM 25 l/m PETRI with 1 SATELLITE PACK (25 litres/min flow rate) (*) |
(*) each PACK consists of: 1 TRIO.BAS RABS ISOLATOR with battery charger, 1 calibration certificate, 1 s/s satellite, 1 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable connection (5 mt) (code 265), 1 cable for data transfer and 1 robustus medium carrying case
Code | SATELLITE UNIT for CONTINUOUS MONITORING |
---|---|
851K | CONTINUOUS SATELLITE UNIT Petri PACK |
Code | EACH PACK CONSIST OF: |
---|---|
830 | S/S ASPI HEAD PETRI CM |
465 | COVER HEAD s/s to protect ASPI HEAD |
265 | Cable connection between the Satellite and the command unit - 1 set of 5 meters |

TRIO.BAS RABS ISOLATOR CM + 1
SATELLITE CM

TRIO.BAS RABS ISOLATOR + 2
SATELLITES CM

TRIO.BAS RABS ISOLATOR CM + 3
SATELLITES CM
REMOTE SYSTEM
REMOTE FUNNEL
IDENTIFICATION CODES
Code | REMOTE FUNNEL SYSTEM |
---|---|
181 | REMOTE FUNNEL SYSTEM in s/s AISI316 with tri clamps connection, funnel and bell - carrying case included |


REMOTE HEAD
IDENTIFICATION CODES
Code | REMOTE HEAD SYSTEM |
---|---|
192 | REMOTE HEAD SYSTEM Petri 90 plate in s/s AISI316 with tri clamps connection - carrying case included |
Code | ACCESSORIES for REMOTE SYSTEM |
---|---|
140 | s/s valve for REMOTE SYSTEM with 2 TRI clamps connection |
184 | silicone tube with 2 TRI clamps connection - 50 cm lenght |
185 | silicone tube with 2 TRI clamps connection - 100 cm lenght |
186 | silicone gasket for TRI clamp |
187 | s/s cap clamps |
188 | s/s 90° elbow short tube with 2 TRI clamps connection - wheelbase 40 mm |
193 | s/s tri clamps with silicone gasket |
194 | s/s tube with 2 TRI clamps connection - 100 mm lenght |
Code | REMOTE HEAD SYSTEM |
---|---|
194/1 | s/s tube with 2 TRI clamps connection - 200 mm lenght |
194/2 | s/s tube with 2 TRI clamps connection - 500 mm lenght |
195 | s/s 90° elbow long tube with 2 TRI clamps connection - wheelbase 89 mm |
197 | s/s hexagonal pipe hook with inserts - 100 mm |
189 | s/s wall connection with 2 TRI clamps connection (wall < 5mm) |
198 | s/s wall connection with 2 TRI clamps connection - size 80 mm lenght (wall > 5mm) |
199 | s/s floor pole - base diameter 250 mm - lenght 1 mt |