Sterilization and Particle Removal Pharmaceuticals

Sterilization and Particle Removal (Pharmaceuticals). A great many of the drugs and solutions produced by the pharmaceutical industry or made up in the hospital pharmacy have to be both sterile and relatively free of particulate mat-ter-especially if the product is to be injected into the bloodstream. For drugs and other products that will not withstand heat, sterilizing filtration is the only alternative. Tissue culture media, parenteral solutions, vaccines, human plasma fractions, antibiotics, diagnostic injectables are all sterilized by membrane filters. 

Even if MF has been applied by the manufacturer, the solution may need to be filtered again by the pharmacist due to contamination during mixing or reconstitution. A single microorganism can grow into thousands overnight. Serious and sometimes fatal infections can result. 

There is a growing clinical evidence that particulate matter in IV solutions can also be a serious health hazard. Direct blockage of blood vessels can occur. For example, the partial occlusion of retinal arteries can result in blind spots. Clot formation and emboli result because of the tendency of red cells to adhere to particles. Granulomas have resulted from inflammatory reactions where a particle is embedded in tissue. 

Achieving low particulate levels in the final drug or parenteral solution usually requires filtration of the constituent water. The United StatesPharmacopoea defines specifications and methods for production of water for injection. Ultra-pure water systems in the pharmaceutical industry use reverse osmosis, ion exchange, and MF just as in the electronics industry (see below). Both industries seek to produce sterile/particle free water. However, in the pharmaceutical in- 

MF is also used to remove microorganisms and particulates from air and other gases used in the pharmaceutical industry. Some specific applications include vent filters filtration of compressed air used in sterilizers, filtration of air or nitrogen used for solution transfers or at filing lines, and filtration of air or nitrogen used in fermentors. 

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