This FAQ paper is a follow up to the webinar, “3rd Annual Cleanroom Design and Engineering Forum” presented by Anna Campanella. Many thoughtful questions were asked about non-viable particle counting requirements in cleanrooms and sampling placement pertaining to process design. Questions submitted during and after the webinar are answered by Anna Campanella, below. If you have any additional queries for our experts, submit them directly here.
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?
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.