QA Microbiology Sterility Pharma Equipment

QA Microbiology isolators for sterility testing and VPHP decontamination process analysis in pharmaceutical operations and laboratories are one of our product lines.

Modular Equipment

First of all, the Modular Sterility Testing Isolator is perfect for pharmaceutical labs where professionals require aseptic conditions for microbiology quality assurance when testing the sterility of medicinal products. It can test vials, ampoules, syringes, cartridges and other containers.

It is a Grade A fully closed, GMP compliant isolator with laminar airflow. It has a fast decontamination cycle using VPHP and quick installation and validation.

Modular design allows Comecer to build a configuration with a combination of different modules to precisely address customer requirements. Plus, Comecer is also a customization expert, so we can modify the components to fit customer processes and workflows.

QA Microbiology in research laboratories needs equipment to test product sterility following Direct Inoculation or Membrane Filtration methods. This isolator can help.

Decontamination Analysis

A second useful product for QA microbiology is the VPHP Testing Isolator, a system for the analysis of the decontamination processes in the pharmaceutical field. It uses vaporized hydrogen peroxide (VPHP). This isolator contains an integrated VPHP generator. It has a pre-chamber, used for the inlet of materials, and a main chamber for carrying out the sterility analyses.

In addition, this isolator also monitors H2O2 residues inside the chamber and its exposed materials at the end of the decontamination cycle.

Moreover, it can verify extremely low H2O2 concentrations (less than 3ppb) in the final decontamination phases with a high sensitivity sensor.

Finally, this equipment works in positive pressure compared to the laboratory, thus ensuring chamber sterility.