Environmental Monitoring Microbiology and Single Use Solution Validation
Single Use Systems for Environmental Monitoring Microbiology can be a great solution to eliminate costly work such as autoclaving. Aseptic Processing is aimed to maintain the sterility of a product via the assembly from sterile components. It is implemented to prevent microbial contamination.
Here we look at data supporting the validation of a Single Use System for Environmental Monitoring Microbiology – the BioCapt Single Use microbial sampler impactor including a preloaded agar plate.
BioCapt Single-Use has an efficiency performance comparable
to the BioCapt Stainless Steel microbial impactor.
1. The BioCapt Single-Use sampling device has a radial slit impactor design showing physical and biological efficiency performances comparable with the BioCapt Stainless Steel sampling head.
2. The leakage test demonstrated that 100% of the air sampled comes from the air drawn through the slits of the sampling head by the suction effect of a vacuum pump.
3. The BioCapt Single-Use complies with ISO 14698-1 (Clean rooms and associated controller environments – Biocontamination control –Part 1: General principles and methods (ISO14698-1:2003))
4. The quality of the microbiological ready-to-use culture media used to fill the BioCapt Single-Use system complies with the corresponding specific release (Validation study)
