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?
Continuous monitoring helps ensure the sterility of clean manufacturing within the pharmaceutical industry. In the pharmaceutical field, one of the main objectives required by regulatory guidelines is to preserve the sterility of cleanrooms. Cleanrooms are controlled areas where contamination levels are monitored and managed to meet a defined cleanliness level. To reach this goal, it is important to ensure that each GMP requirement is respected over time.
In May 2021, a revision to USP <1788> Methods for Determination of Subvisible Particulate Matter was published in order to provide clarification and support of the information given in chapters USP <788> Particulate Matter in Injections, USP <789> Particulate Matter in Ophthalmic Solutions, and USP <787> Sub-visible Particulate Matter in Therapeutic Protein Injections. While the previous version of USP <1788> only covered the testing requirements for Optical Light Obscuration testing and Microscope testing, the revision expands the scope of testing requirements to include newly viable technologies such as Flow Imaging and new therapeutic protein solutions. Particle Measuring Systems’(PMS) APSS-2000 testing system still fully complies with the requirements for use in the testing of solutions in the Normative Chapters and revised General Chapters.
Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively. This is accomplished by making sure differences are understood and appropriate data conversions can be made to make meaningful comparisons.
