Stability Operating Procedures development

Previously, we developed a prototype model of automated 2DE system which enabled rapid, highly reproducible, and required minimal maintenance (6). All the 2DE procedures including lEF, on-part protein staining, SDS-PAGE, and in situ protein detection were automatically completed. The system completed the entire process within 1.5 h. Recently, an improved model of this system was capable of reliability y and portability, e.g., operational stabilities in both componentry and software, and miniaturization of whole apparatus. Followings are described system components, operational procedure, and data analysis of this 2DE system in a hands-on form. 

Fatty Acids. The above process is an old and direct method by which to make soap but if fatty acids are wanted, and their use is increasing, the addition of alkali must be avoided unless subsequent treatment with acid at additional expense iis to be incurred. For making these fatty acids several processes may be used, the autoclave and the traditional Twitched method, which are batch operations, and the more modem continuous-countercurrent procedures developed by Colgate-Palmolive-Peet and by The Procter Gamble Company. Darkening of the resulting products from this type of operation is retarded by the use of hydroxy aromatic compounds as stabilizers. ... 

Preservation of IM meat is complex in nature. The identified stabilization operations/treatments in processing, water activity, and storage temperature of IM meat are never greater than those for other preserved meats (Leistner, 1987). The specific preservation procedure or step for each empirical product cannot be taken for granted, but must be determined by experimentation. The possible involved consequence and/or synergistic stabilization factors developed in the preservation procedure should be subjected to more scientific scrutiny. 

The information on the container and the development pharmaceutics is to cover the qualitative composition (polymeric and other), closure type and method of operation, tightness of the closure, dosing device information, tamper evidence and child resistance, stability of the product in the container, the method of administration of the medicinal product, any sterilization procedures, the ability of the container to protect the contents from external factors,... 

The objective of the present study is to develop a cross-flow filtration module operated under low transmembrane pressure drop that can result in high permeate flux, and also to demonstrate the efficient use of such a module to continuously separate wax from ultrafine iron catalyst particles from simulated FTS catalyst/ wax slurry products from an SBCR pilot plant unit. An important goal of this research was to monitor and record cross-flow flux measurements over a longterm time-on-stream (TOS) period (500+ h). Two types (active and passive) of permeate flux maintenance procedures were developed and tested during this study. Depending on the efficiency of different flux maintenance or filter media cleaning procedures employed over the long-term test to stabilize the flux over time, the most efficient procedure can be selected for further development and cost optimization. The effect of mono-olefins and aliphatic alcohols on permeate flux and on the efficiency of the filter membrane for catalyst/wax separation was also studied. 

Development studies, summarized within a distinct report on the physiochemical aspects, drug substance attributes, and finished product characteristics, become critical parts of the validation package. Such data is also valuable for future integration into a manufacturing operation. This includes the scientific rationale for formulating and bulk-handling procedures, lyophilization processing parameters, finished product analysis, and stability requirements. 

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