Binders used for tablet are highly susceptible to contaminations as no biocides can be added.
As most binders are a mixture of natural ingredients such as cellulose, starch, gelatin, and other polysaccharides, they serve as excellent growth medium for a broad range of microorganisms.
The instability of the binder material emphasizes the importance of fast results when analyzing the microbial quality of the binder, as the concentration will increase over time.
IntuGrow is a method where the microbial quality of binder material can be analyzed in less than 24 hours instead of the 5 days currently specified in USP61/ ph eur 2.6.12.
