Bio SERV Release: 3 Essential Methods An Aseptic Liquid Fill And Finish Contract Pharmaceutical Manufacturing Service In The U.S. Must Have
Published: Dec 17, 2013
December 17, 2013 -- There are many reasons why a pharmaceutical company may want to seriously consider using an aseptic liquid fill and finish contract pharmaceutical manufacturing service in the U.S. The sole purpose of using an aseptic system is to effectively eliminate any microorganisms that may lead to an infection in the end-user. These types of systems are an excellent means of maintaining sterility at the various stages of the manufacturing process. This method is often used most effectively for products that will later be used for injection. Because of the high level of risk to life and health, it is extremely critical that the environment for production is just as safe as the drug itself. There are many ways that a manufacturing company can accomplish this. Preparing the Environment From the very beginning of the process, aseptic methods of sterilization have to begin in a cleanroom. Determining whether a location qualifies as a viable cleanroom will be based on the amount of living matter that exists. A class, 100,000 cleanroom for example, must have less than 100,000 particles of 0.5 microns in a cubic foot of air. For aseptic manufacturing locations, that number must be drastically reduced to 100 microns or lower. This brings the risk factor of contamination before filling to a miniscule level. Sterilizing the Product Once the location has been properly prepared, the product then needs to be sterilized. Using heat, irradiation, and filtration methods designed to remove the majority of bacteria and molds that may have developed can do this. Filtering processes must be regularly tested before and after the fill to maintain the integrity of the product. Sealing the Product Once the product is sterilized it is then moved to a holding tank that keeps the product in a pure state until ready to fill. These tanks are usually pressurized to prevent any chances of contamination from microbes; even the valves that the handlers use to control the pressure must be steam sterilized on a regular basis. From this point, the product can be safely filled into vials and packaged in air-tight containe rs and readied for shipment. The main goal of an Aseptic Liquid Fill and Finish Contract Pharmaceutical Manufacturing service in the U.S. is to maintain the purity of the product from the start to the finish. It may seem like a simple thing to fill a vial with liquid, but it is a far more complex process than the average person may understand. For a pharmaceutical company, it is absolutely necessary that the integrity of the drug be maintained and that all possible variables for contamination are addressed throughout the entire manufacturing process.
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