New possibilities in microbial contamination control

Hyclas © PMT

Regulations in the pharmaceutical environment continue to pose challenges for applications in critical process environments. However, they also open up new possibilities in microbial contamination control.

PMT Particle Measurement Technology GmbH is expanding its product portfolio with the Hyclas impact microbial sampler.

The microbial sampler combines traditional microbial collection with continuous contamination monitoring in critical process areas. It can be used both in standalone operation and in stationary monitoring mode.

Thanks to the stainless steel housing, the Hylcas devices are suitable for use in cleanrooms and are also compliant with ISO 14698-1:2003 and EN 17141:2020. The impact microbial sampler is available in different versions. One as a portable variant with an integrated display and another as a stationary version. This is used for continuous contamination monitoring in, for example, isolators and RABS. Due to the integrated vacuum supply, only a power connection needs to be installed at the installation site.

Hydra is an extension of the stationary microbial sampler. Multiple units are connected to form a monitoring system. The current version of EU-GMP Annex 1 requires continuous microbial monitoring throughout the entire process. The special mechanism of Hydra enables exactly this. Additionally, the Hyclas's Modbus compatibility allows the individual units to be controlled via, for example, an HMI.

– Mobile/stationary air microbial sampler
– Integrated vacuum supply
– Available with 100 LPM or 180 LPM
– Battery operation / mains operation (depending on the version)
– Conforms to ISO 14698-1:2003 and EN 17141:2020 as well as 21 CFR Part 11
– Remote control possible
– 316 L stainless steel
– Uses standard 9 cm Petri dishes