4th September 2018 Content supplied by: Sartorius AG
Air Monitoring: Continuous Monitoring in Grade A and B
During critical processing, monitoring of viable particles in air should be performed uninterrupted and continuously to ensure process integrity, products safety and ultimately patients safety.
Sartorius 30-year proven Gelatine air monitoring devices filter class A and B air during processing, avoiding the introduction of agar into the critical spaces. In addition, the gelatine filters can filter for more than 8 hrs non-stop without dehydration, enabling you to do continuously monitor your production without interruption.
The sterile air monitoring filters can be introduced into the isolator using a Biosafe Port for solid material. The integrated air monitoring instrument, the MD8 airscan® filter holder including the air flow passage were sterilized during the regular HVAC process of the isolator, by adjusting the Airscan airflow to the laminar flow inside the Isolator to ensure full effectiveness of the HVAC process. Simply place the Air Monitoring filters onto the MD8 Airscan Filter holder device and sample the entire production shift. After usage, the filters can be placed back into the Biosafe Bags and transferred out of the Isolator via the Biosafe port. After transfer into the Microbiolgical QC laboratory, Collected viable particles can be grown on regular agar outside the critical space by simply placing the gelatine filter onto a regular agar plate before incubation.
- 8 hrs non-stop air monitoring inside class A and B environments enables continuous monitoring of critical processes
- Bacteria, Viruses and Phages can be collected by size and adhesion on Gelatine Air Monitoring filters
- The Air monitoring instrument MD8 Airscan is built into the isolator and can be adjusted to HVAC air flow rate during the decontamination cycles
- adjustment of Air Monitoring airflow to Isolator air flow ensure laminar flow and effective sterilization of all parts in contact with air
- Sterile Gelatine Air monitoring filters in Biosafe Bags can be introduced into the production space using Biosafe Ports
- written Risk Assessment on parts replacement MD8 Airscan available upon request
- IQ/OQ Installation Service and Maintenance Service
Date Published: 4th September 2018
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