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Pharmaceutical products, steril isolators

As pharmaceutical products contain increasingly potent active constituents and as health, safety, and environmental protection issues increase in importance, isolators have been developed in many shapes and forms to permit thesafe weighing and subdivision of highly active compounds. The most sophisticated applications, such as the subdivision of bulk sterile active compounds, require that the isolator maintain aseptic processing conditions internally at the same time as satisfying the safety requirements. Fig. 2 shows an isolator device designed to allow a keg of potent... [Pg.2135]

Many isolator applications at the clinical trial scale of manufacturing are based on the same scale of technology used for sterility testing. The aseptic dispensing of pharmaceutical products in hospital pharmacies is also carried out on this scale. Such manufacturing is not carried out on a continuous basis, but in relatively small batches that can be transferred from the isolator with the help of one of the more secure transfer systems. In this type of application, one isolator is being used to dispense a variety of products or several isolators are used for separate tasks. [Pg.2136]

Downstream processing involves employment of a purifying system that can isolate the product in as few steps as possible using the simplest purification technology that will achieve the required purity. While purity is a critical consideration for both small-molecule pharmaceuticals and biopharmaceuticals, the nature of biopharmaceutical administration (typically via injection) and the nature of biotechnology processes require that additional considerations be paid to the purity of biopharmaceuticals. The final product must meet regulatory purity and sterility standards and must be below the maximally acceptable cellular or microbial contamination (Ho and Gibaldi, 2003). [Pg.199]

Final product isolation in a form suitable for further processing into the final dose form of the pharmaceutical, e.g., as a tablet or an injectable solution. Secondary production of this type is sometimes done in a separate facility, with the raw material referred to as the bulk product or, more recently, the active pharmaceutical ingredient. Examples of unit operations at this stage of processing include lyophilization, precipitation, or crystallization followed by solid isolation using filtration and drying techniques. In some cases, the final product must be produced in a sterile form, which introduces additional complications when selecting suitable process equipment. [Pg.637]

At present, the pharmaceutical industry regulatory requirements refer to isolators specifically in the context of the manufacture of sterile products. There is no reference to their role in broader areas of crosscontamination and operator safety control. Within Europe, the current EU GMP clearly states that isolators might produce improvements in sterility assurance of sterile products, and that aseptic processing manufacturing isolators should be placed in at least a Grade D surrounding environment. The Food and Drug Administration (FDA) requirements are less well defined, but it is likely that in equivalent circumstances, they would like to see an isolator located in a class 100,000 or M6.5 environment In Operation. ... [Pg.2134]

Sterile processing facilities require additional levels of sophistication. Active pharmaceutical ingredients manufactured for sterile use are required to be completed (usually the isolation/purification steps) in a sterile facility. The sterile facility is designed to minimize the exposure of the product from microbial contamination. [Pg.146]

Clothing the operator completely in an impervious plastic suit represents the ultimate in personal protection and has the additional merit of isolating the product completely from operator and such suits have been used to maintain sterility during pharmaceutical manufacture. Isolator suits should not be used as the primary means of protecting the operator but must be used only in combination with effective techniques for safely dispensing, handling and freeze-drying hazardous products. [Pg.207]


See other pages where Pharmaceutical products, steril isolators is mentioned: [Pg.643]    [Pg.291]    [Pg.514]    [Pg.232]    [Pg.313]    [Pg.259]    [Pg.439]    [Pg.728]    [Pg.227]    [Pg.459]   
See also in sourсe #XX -- [ Pg.43 , Pg.504 ]




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