Microfiltration pharmaceutical

Downstream Processing Microfiltration plays a significant role in downstream processing of fermentation products in the pharmaceutical and bioprocessing industry. Examples are clarification of fermentation broths, sterile filtration, cell recycle in continuous fermentation, harvesting mammahan cells, cell washing, mycelia recovery, lysate recovery, enzyme purification, vaccines, and so forth. 

Pharmaceutical Removal of suspended matter is a frequent application for MF. Processes may be either clarification, in which the main product is a clarified liquid, or solids recovery. Separating cells or their fragments from broth is the most common application. Clarification of the broth in preparation for product recovery is the usual objective, but the primary goal may be recovery of cells. Cross-flow microfiltration competes w l with centrifugation, conventional filtration by rotary vacuum filter or filter press and decantation. MF delivers a cleaner permeate, an uncontaminated, concentrated cell product... 

Generally, a distinction can be made between membrane bioreactors based on cells performing a desired conversion and processes based on enzymes. In ceU-based processes, bacteria, plant and mammalian cells are used for the production of (fine) chemicals, pharmaceuticals and food additives or for the treatment of waste streams. Enzyme-based membrane bioreactors are typically used for the degradation of natural polymeric materials Hke starch, cellulose or proteins or for the resolution of optically active components in the pharmaceutical, agrochemical, food and chemical industry [50, 51]. In general, only ultrafiltration (UF) or microfiltration (MF)-based processes have been reported and little is known on the application of reverse osmosis (RO) or nanofiltration (NF) in membrane bioreactors. Additionally, membrane contactor systems have been developed, based on micro-porous polyolefin or teflon membranes [52-55]. 

The primary market for the disposable cartridge is sterile filtration for the pharmaceutical industry and final point-of-use polishing of ultrapure water for the microelectronics industry. Both industries require very high-quality, particle-free water. The cost of microfiltration compared to the value of the products is small so these markets have driven the microfiltration industry for the past 15 years. 

Microfiltration is used widely in the pharmaceutical industry to produce injectable drug solutions. Regulating agencies require rigid adherence to standard preparation procedures to ensure a consistent, safe, sterile product. Microfiltration removes particles but, more importantly, all viable bacteria, so a 0.22- xm-rated filter is usually used. Because the cost of validating membrane suppliers is substantial, users usually develop long-term relationships with individual suppliers. 

Cold sterilization of beer using microfiltration was introduced on a commercial scale in 1963. The process was not generally accepted at that time, but has recently become more common. Sterilization of beer and wine is much less stringent than pharmaceutical sterilization. The main objective is to remove yeast cells, which are quite large, so the product is clear and bright. Bacterial removal is also desirable a 106 reduction in bacteria is equivalent to the best depth filters. The industry has found that 1-p.m filters can remove essentially all the yeast as well as provide a 106 reduction in the common bacteria found in beer and wine. Because the cost structure of beer and wine production is very different from that... 

This membrane industry is very fragmented. Industrial applications are divided into six main sub-groups reverse osmosis ultrafiltration microfiltration gas separation pervaporation and electrodialysis. Medical applications are divided into three more artificial kidneys blood oxygenators and controlled release pharmaceuticals. Few companies are involved in more than one sub-group of the industry. Because of these divisions it is difficult to obtain an overview of membrane science and technology this book is an attempt to give such an overview. 

Primary recovery of the active ingredient from the solid or liquid phase to remove large quantities of unwanted waste materials, which may themselves be processed further. Suitable techniques include solvent extraction, precipitation by chemical or physical changes to the product-containing solution, and ultrafiltration or microfiltration to separate products above a particular size. Work done on combined biomass separation-primary product recovery processes such as expanded-bed adsorption are now being commercialized in the pharmaceutical industry. 

Other The cassette (Fig. 22-54), a modification of a plate-and-frame device that is favored because of the ease of scale-up from laboratory to small plants is widely used in pharmaceutical microfiltration and ultrafiltration. An entirely different module also called a cassette is used in the MF of water. There are a host of other clever module designs in use, and new ones appear frequently. 

Microfiltration Biotechnology, chemicals, electronics, environmental control, food beverage, pharmaceutical 550 million 1.5 billion... 

Sales of microfiltration equipment and membranes are expected to rise from 1.9 billion worldwide in 2005 to 2.5 billion in 2008. The main applications are the production of sterilized water for the pharmaceutical and biotechnology industry. 

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