The Pharmaceutical Process

Figure 9.7 The cold composite stream for the pharmaceutical process.

Dedicated to Theodore E. Byers, formerly of the U.S. Food and Drug Administration, and Heinz Sucker, Professor at the University of Berne, Switzerland, for their pioneering contributions with respect to the pharmaceutical process validation concept. We also acknowledge the past contributions of Bernard T. Loftus and Ira R. Berry toward the success of Pharmaceutical Process Validation. 

With the emergence of the pharmaceutical process validation concept, the following four additional steps have been added ... 

DMF is used primarily in the pharmaceutical processing and acrylic fiber production industries. These uses account for about 50% of the total demand. 

There are a variety of different depth filter and membrane filter materials used within the pharmaceutical processes. Depth filter are fibrous materials for example, polypropylene, borosilicate, or glassfibre fleeces (Fig. 3). Borosilicate and glassfibre materials are highly adsorptive and commonly used to remove colloidal substances, like iron oxide from water or colloidal haze from sugar solutions. 

Of the melt-processible fluoropolymers, which are the most suitable for tubing, PFA provides the extreme thermal and chemical resistance required in the pharmaceutical processing. PFA, however, does not have the physical strength of PTFE at elevated temperatures... 

The best approach to assessing problems with respect to a terminal sterilization method (i.e., moist heat, dry heat, radiation, and chemical methods) is to first establish the qualification, validation and stability of the pharmaceutical process prior to conducting a given sterilization procedure. 

Any person who is deemed to be sick, either by medical examination or by the production supervisor, shall be excluded from direct contact with the pharmaceutical process until the condition is corrected. 

Whichever of these routes is used to obtain a bulk drug constitutes the chemical process. Further processing of the bulk drug to obtain the dosage form constitutes the pharmaceutical process. This distinction is depicted in Fig. 4, where simple... 

The newness of these testing points has spurred a plethora of new companies and instrumentation. In addition to traditional spectroscopic ranges, laser-induced fluorescence, thermal effusivity, and acoustics (passive and active) have made appearances. Raman has also become process-hardened, along with other techniques. In the rush to be part of the pharmaceutical process revolution, some very interesting new players have entered the game. 

Excipients in the pharmaceutical processing operations may originate from a wide variety of sources, including plants (e.g., starches, sugars, celluloses), animals (gelatin, lactose, shellac), minerals (e.g., dicalcium phosphate dehydrate, magnesium stearate), and from synthetic origin (e.g., polyvinylpyrolidone, polysorbates. 

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