6533b7dafe1ef96bd126dfbb

RESEARCH PRODUCT

Aseptic Production vs. Terminal Sterilization

subject

description

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 values. Although many manufacturers claim their products to be pyrogen-free, this is hardly ever attained in practice. The lowest acceptable endotoxin concentration of a substance used intraocularly has not yet been established. For some manufacturers, a concentration of up to 3 EU/ml is acceptable. It is in fact not yet clear at which concentration exactly inflammatory reactions occur in mammals. It seems justified to require < 0.5 EU/ml, as is standard for other medicinal products intended for injection into the human body. As increasingly confusing terminologies have been noted up lately, certain terms should be elucidated (Sharp, 1995). The term sterility is defined as the complete absence of living organisms (so-called “Orange Guide”, 1983). Sterility is an absolute State; i.e., there is no gradual grading of sterility. Sterile is defined as that which is in the state of sterility (Sharp, 1995). An OVD batch can be sterilized by different methods, however, the probability of a non-sterile particle in the batch is dependent on the method employed. This probability is described as SAL (sterility assurance level) and represents the highest probability of non-sterility of a unit, after the sterilization process.