Study of Single Use Device Performance After 4-Hour Continuous Sampling
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The scope of this study was to evaluate the BioCapt® Single-Use’s (BCSU’s) ability to recover microorganisms in stressed conditions after four hours of continuous air sampling at 28 LPM. The European Pharmacopoeia Growth Promotion Test performed on the BCSU after incubation shows a good recovery rate (≥ 70%), comparable between the two impactors tested (stressed and unstressed). All three test results aligned with acceptance criteria, and visual inspection of the media post-sampling was satisfactory. This study supports the use of BCSU for four-hour sampling with no change to its monitoring capabilities.
The BioCapt® Single-Use (BCSU) is an inertial impactor with elliptic cuts (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 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 used for disinfection of surfaces and/or Lactamator®, an enzyme inactivating a broad-spectrum of beta-lactam antibiotics. As a result, residues of disinfectants and antibiotics present in the environment do not inhibit the growth of bacteria sensitive to them.
This product is an appropriate choice for active monitoring of air environments, and the formulation with Lactamator® is the most appropriate solution where contamination or production of beta-lactam antibiotics is present.
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