A population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI.
Source: GMP Draft Annex 1
10 Steps to a Cleaner Cleanroom
The risk of contamination affecting a product increases as operator activities increase within a cle...Read more
A true cleanroom panel, this system is perfect for projects which need to adhere to GMP guidelines.Read more
ISO 14644-1:2015 Compliant Cleanroom Monitoring
ISO 14644-1 specifies the classification of air cleanliness in terms of the concentration of airborn...Read more