Sterile product comes in contact with compressed gasses and air at numerous points in any production process. Microbial contamination can exist in the valves or lines that are used to feed gas and air into critical, aseptic manufacturing environments. Microbial monitoring of the gasses and air which pass through these lines is therefore a critical component of any environmental monitoring program.
The M Air T System is designed for active air sampling from isolator and barrier environments. The M Air T compressed gas and air test kit, used with the M Air T isolator pump, offers operators a uniquely convenient and reliable method of sampling compressed gas and air. The sampling head automatically converts the compressed air or gas sample, which can be at pressures of up to 5 bar (73 psi), to atmospheric conditions, thereby providing accurate, reliable sampling. Automated operation and short-duration, high-volume sampling reduces the time and effort required for monitoring and validating aseptic conditions.
Unlike other systems, which may require separate flow meters, the M Air T System is complete. There’s no vacuum calibration needed, and no additional equipment required that could introduce contamination into the sampling area.
Operators easily create and store airflow parameters, set run-time, and specify criteria for multi-cycle operation on the pump’s user-friendly control panel. Sampling is fast, processing 1000 L of air in fewer than 8 minutes.
A start-delay timer allows the operator to leave the area before testing begins. The system stops automatically.
The pump’s software simplifies documentation and reporting. Operators may easily download data such as sampling parameters, operator ID, test objective and location, as well as other plant specific details to personal computers.
Comprehensive protocols are available to make validation faster and easier. The validation protocol book contains ready-to-use installation, operation and performance qualification protocols that are written to the same standards as protocols used to validate pharmaceutical processes.
|Materials of Construction|
|M Air T Compressed Gas and Air Test Kit||Pressure reducer, cone adapter, sieve and TC clamps: 316 L Stainless steel; TC gaskets: silicone|
|M Air T Air Tester for Isolator Pump||Frame: 316L stainless steel; Casing: Polyurethane with acrylic lacquer; Handle: Stainless steel epoxy paint; Keypad: Polycarbonate|
|Width, mm||Depth, mm||Height, mm||Weight, kg|
|M Air T Compressed Gas and Air Test Kit||170||130||310||3.5|
|M Air T Air Tester for Isolator Pump||325||340||200||9.3|
|TC Gaskets||1.5 in. (38.1 mm)|
|TC Gaskets||4 in. (101.6 mm)|
|Air Flow||136 LPM (auto-regulated)|
|Regulatory Compliance||CE marked|