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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