The scope of this study was to verify the performance of collecting contamination from continuous three-hour samplings using the BioCapt® Single-Use manufactured by Particle Measuring Systems under unidirectional airflow, at 22 °C with 48% relative humidity.
All four test results aligned with acceptance criteria, and visual inspection of the media post-sampling was satisfactory. With the backing of this study, BioCapt Single-Use can be used for three-hour sampling with no change to its monitoring capabilities.
The BioCapt® Single-Use (BCSU) is an inertial impactor with elliptic cuts (also known as slits) used to perform microbiological analysis and monitoring of air. It is made of transparent polystyrene, with visible culture media. It is composed of three separable parts:
- The base holding the culture media.
- The lid with slits for air aspiration.
- The cap that covers the lid.
BCSU microbial impactor contains ready-to-use (RTU) culture media in packaging sterilized by irradiation.
A vacuum source connects to the side adapter to allow a constant flow of air into the device. After sampling and incubation, the lid can be removed for additional colony testing.
Diverse formulations of BCSU are available. The media can include neutralizing agents to counter the effects of bactericidal or bacteriostatic disinfectants, including penicillinase―an enzyme inactivating a broad-spectrum of beta-lactam antibiotics―used for cleaning of surfaces. As a result, antibiotics present in the environment do not inhibit the growth of bacteria sensitive to them.
This product is an appropriate choice for monitoring environments that have been disinfected, and where contamination by beta-lactam antibiotics may be present, especially where beta-lactam antibiotics are produced.
Methods
Before the start of the study, BCSU performance was tested by evaluating the microorganisms’ dehydration and recovery efficiency by growth promotion test. The supplier also validated the biological and physical efficiency of their biological monitoring system.
All testing occurred in an isolator. Four tests were carried out to determine the performance of the BCSU, designed and manufactured by Particle Measuring Systems, under specific sampling conditions testing for Environmental Temperature, Environmental Humidity (%), and Aspiration Flow. The following tests were conducted:
- Test 1: Stress Capability Test, Dirty to Sterile Sampling
- Test 2: Stress Capability Test, Sterile to Dirty Sampling
- Test 3: Recovery Efficiency after 3-hour-and-10-minute Sampling under the UDAF
- Test 4: Recovery Efficiency before 3-hour-and-10-minute Sampling under the UDAF
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