GENIUS SYSTEM - Microbial Air Sampling Modular System

The GENIUS SYSTEM is a microbial air sampling modular system, consisting of multiple and independent satellites managed by a software.

Unlike the TRIO.BAS RABS ISOLATOR or TRIO.BAS MULTIFLEX, which feature one command unit and a maximum of three satellites, the GENIUS SYSTEM supports more satellites with different flow rates and programs. Additionally, the command unit is replaced by a software running on a dedicated PC tablet.

The idea behind the GENIUS SYSTEM is moving from a simple air sampler to a complete air monitoring.

The updated GMP ANNEX 1 standards introduce a significant change in microbiological air monitoring. In class A and B areas, microbiological air sampling must be conducted continuously for the entire duration of the production shift.

ORUM has developed a monitoring system that meets regulatory requirements by providing flexible solutions tailored to the specific needs of end users. It facilitates operator activity, reduces risks, simplifies regulatory audits and calibration. It also enables data comparison across different areas using a consistent baseline.

Unlike particle sampling, which does not require an operator at the sampling point, microbiological sampling involves several steps requiring operator intervention to load, sample, and collect culture plates at the end of sampling. These tasks are risky, especially for long-term continuous sampling and when samples are spread across multiple locations. Ensuring proper coordination of these phases helps to minimize the risk of errors.

The intelligence of the GENIUS satellite is represented by the presence of a display on each individual satellite, governed by electronics inside the satellite- The display reports in real time all the phases of the sampling cycle which can be viewed and managed by the operator independently of an overall view detectable on the command console.

The GENIUS system is designed to meet the needs of market sectors where multiple microbiological sampling satellite (points) must be managed (such as drug production lines). Each of these satellites can be controlled as part of the Genius system or, if required, can be integrated with other control instruments (such as particle counting, temperature and humidity sensors, differential pressure, air flow velocity, etc.) and therefore typically within SCADA.

The GENIUS system allows the management of multiple satellites (from 1 to 24) via a central console command unit where dedicated software is installed and, depending on the number of satellites, with different hardware options as field interface and special adapters (splitter boxes).

SATELLITE SLIT HOLES TO AGAR (SATELLITE ROTATION PLATE)

The air impacts the agar media plate at a flow rate of 15 l/m through a single row of holes. The Petri dish is fixed on a support which rotates slowly. In this way the air always impacts only a virgin area of the agar.

Various advantages are obtained:

• no dehydration of the agar
• the risk of contamination is reduced as operator intervention is limited to the set up phase only
• possibility to identify exactly the moment in which contamination occurred
• reduction of costs as one single Petri plate is used to monitor up to 4 hours

REGULATORY ADAPTATION

The instrument was designed to meet key FDA requirements for acceptable environmental monitoring, as outlined in the Sterile Drug Products Produced by Aseptic Processing Guidelines. It is fully compatible with national and international standards for environmental air monitoring: The Rules Governing Medicinal Product in The European Community Vol. IV: Guide to Good Manufacturing practice for medicinal products, 199207.

ISO EN 16498-1 and 2 Clean rooms and associated controlled environments-Biocontamination.