Biomedical product applicable standards

ASTM. F2103-01 Standard guide for characterization and testing of chitosan salts as starting materials intended Iot use in biomedical and tissue-engineered medical product applications (2001)... 

One of the most important inputs for the project development of a biomedical product is the analysis of applicable regulatory standards. Where there are nationally or internationally recognized reference standards, the definition of the requirements of a biomedical product is facilitated. 

Models and reference standards applicable to design and production of biomedical products... 

Various novel applications in biotechnology, biomedical engineering, information industry, and microelectronics involve the use of polymeric microspheres with controlled size and surface properties [1-31. Traditionally, the polymer microspheres larger than 100 /urn with a certain size distribution have been produced by the suspension polymerization process, where the monomer droplets are broken into micron-size in the existence of a stabilizer and are subsequently polymerized within a continuous medium by using an oil-soluble initiator. Suspension polymerization is usually preferred for the production of polymeric particles in the size range of 50-1000 /Ltm. But, there is a wide size distribution in the product due to the inherent size distribution of the mechanical homogenization and due to the coalescence problem. The size distribution is measured with the standard deviation or the coefficient of variation (CV) and the suspension polymerization provides polymeric microspheres with CVs varying from 15-30%. 

This review describes currently useful methods for the separation and characterization of inorganic complexes. Some separations are required just to remove unreacted reagents or minor side products. Advances for these standard techniques (ion chromatography, normal and reversed-phase chromatography, thin-layer methods) are often limited by the availability of a specialized support material. However, newer, innovative methods for the separation of species have evolved, particularly separation methods needed in biomedical and industrial applications. 

Recombinant enzymes have been produced and purified via these methods at market costs as low as 23/lb (110) these costs are likely acceptable for protein polymers with a primary commercial use as a high value biomedical material. For large commercial materials applications, however, lower cost production and purification will be required. Additional advances in fermentation, such as the use of secretion, may help drive costs down, although currently the yields of protein obtained by protein secretion systems have generally tended to be much lower than those of the standard intracellular accumulation systems. 

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