A new thermogelling chitosan-glycerophosphate system has been recently prop
osed for biomedical applications such as drug and cell delivery, The object
ives of this work were to characterize the effect of steam sterilization on
the in vitro and in vivo end performances of the gel and to develop a filt
ration-based method to assess its sterility. Autoclaving 2% (w/v) chitosan
solutions for as short as 10 min resulted in a 30% decrease in molecular we
ight, 3-5-fold decrease in dynamic viscosity, and substantial loss of mecha
nical properties of the resulting gel. However, sterilization did not impai
r the ability of the system to form a gel at 37 degreesC. The antimicrobial
activity of chitosan against several microorganisms was evaluated after in
oculation of chitosan solutions and removal of the cells by filtration. It
was found that, although chitosan was bacteriostatic against the heat steri
lization bioindicator Bacillus stearothermophilus, the bacteria could rapid
ly grow after separation from the chitosan solution by filtration. This ind
icated that B. stearothermophilus is an adequate strain to validate a heat
sterilization method on chitosan preparations, and accordingly this strain
was used to assess the sterility of chitosan solution following a 10 min au
toclaving time. (C) 2001 John Wiley & Sons, Inc.