The last two decades started a change in how microbiological methods are being performed, using rapid microbiological methods (RMMs) and alternative microbiological methods. In many places, microbiological identification ... read more

If you have been in the pharmaceutical industry for any length of time, you have probably been exposed to some concern in your facility regarding fungi, i.e., yeasts and molds. The New England Compounding Center (NECC), of ... read more

It has been reported that microorganisms live social lives. They can use coordinated chemical and physical interactions to form complex communities. These communities are very intricate systems which coordinate microbial ... read more

Endotoxin results have been a major area of concern, especially in the biologics area due to issues with low endotoxin recovery. In some recent years, there were regulatory concerns about whether we were properly inoculating ... read more

Recently, a number of different documents have been making statements similar to “incubation conditions and media used must be justified”. Many companies were able to cite USP as a rationale for using two different ... read more