Use of Membrane Filters in Production Technology for Sterile Drugs

Abstract

Filtration is one of the methods on which all the world's chemical-pharmaceutical industries depend. This technological method is used for the sterilization of labile drugs and to provide them with the required properties. As a result of the introduction of strict GMP rules, most current plants use membrane filtration. We review here the main criteria used for selecting material for sterilizing filtration and provide examples of drugs whose manufacture uses this method.

Improvement of the filtration and antifouling performance of a nanofibrous sterile membrane by a one-step grafting zwitterionic compound

“…Firstly, each membrane was pressurized with deionized water at 0.2 MPa for 0.5 h. Then the test solution was changed to 0.5 g L À1 BSA solution. The calculation of the BSA flux was performed using eqn (1).…”

“…For example, thermal sterilization of some solutions may change the pH of the solution and result in the formation of precipitates. 1 Sterilization filtration becomes more and more important in the downstream purification process of the pharmaceutical industry to reduce the overall bioburden and maintain low pyrogen levels. 2 Compared with other sterilization methods, sterilization filtration is simpler to operate and causes little damage to the drug products, especially heat-unstable biological drug products.…”