This FAQ paper is a follow up to the webinar, “ISO EN 17141 & ISO 14968 Overview”.
Some questions covered in this paper are
Is there any guidance or requirement that applies in a quality control laboratory? Or are they only applicable for cleanrooms in manufacturing areas?
How do I check the particles in nitrogen gas, and what are the specifications?
This FAQ paper covers a wide spectrum of important information about the BioCapt Sinlge Use 100 Microbial Impactor, including questions such as:
What is the part number?
What are the main differences from BCSU 25/50 LPM?
Which types of agar media are available?
Are the raw materials the same as the other BCSU’s?
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.
This guide, which was built from the Beginner Guide to Particle Counting, helps those new to particle counting get comfortable with the basic details and concepts around monitoring and controlling contamination.
