Search results for "Sterility assurance level"

Aseptic Production vs. Terminal Sterilization

2000

The safety of substance use in intraocular surgery ideally requires the absence of all biologically-active components capable of causing an inflammatory reaction. Substance purity is achieved with isolation and cleansing methods (e.g., of the polysaccharide), which remove any biological component with infective potential. The methods of production for polysaccharide isolation should remove biological agents, regardless of its origin. Hyaluronic acid is isolated either from rooster combs or biological fermentation. Use of this substance showed the development of postoperative intraocular inflammatory reactions resulting from contaminations from both sources. OVD should have low endotoxin val…