Stability Operating Procedures types

Provisional specifications have been created for all packaging components, and these are subsequently used to clear all materials through a QC plus type operation prior to use in any tests, irrespective of whether these are feasibility or formal stability studies. Procedures should include (for plastics) material identification (by IR, UV, differential scanning calorimetry (DSC), etc.), physical assessment including dimensions and functional tests, and should be of greater technical and scientific depth than the QC procedures used for subsequent regular incoming production materials (hence the use of the phrase QC plus ). 

Two types of latexes were used for the experiments, one was polystyrene latex synthesized in the laboratory, and the other was a commercial product of SBR. Polystyrene latex was used to fix the operational procedures and to test the feasibility of the apparatus. It was prepared frcm a usual batch synthesis with a later addition of styrene moncmer to increase total solid without damaging latex stability. To obtain one litre of the latex with approximately 36 wt.% total solid, 6.67 gr. of sodium lauryl sulfate, 1.00 gr. of ammonium persulfate were used to the mixture of 600 ml. of water and 200 ml. of styrene. Additional styrene of 200 ml. was added continuously after 20 min. elapsed frcm the initiation with a charge rate of 200 ml/hr. Tenperature was maintained at 60 °C, and the reaction was terminated after 4 hr. 

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. 

The frequency of OQ/performance verification depends not only on the type of instrument and the stability of the performance parameters, but also on the acceptance criteria specified. In general, the time intervals should be selected such that the probability is high that all parameters are still within the operational specifications. Otherwise, analytical results obtained with that particular instrument are questionable. The OQ/performance verification history of the type of instrument can be used to set reasonable test intervals. Here the importance of proper selection of the procedures and acceptance limits becomes very apparent. 

At the same time, internal quality control must be carried out to verify the performance stability of the limited-scope performance of the method. Triply redundant verification methods are carried out with regard to control of first, second and/or third line, each set of methods applied to a particular type of test. The first line of verification involves pro forma repetition of all the steps of the test, in order to establish repeatability or reproducibility for quantitative tests, and to verify the range of sensitivity or detection for qualitative tests. This verification is performed by the experimenter himself, as part of the proper performance of the test. A second line of verification is put into operation by administrative decision, and includes testing with blind samples, repetition of samples, internal audit procedures, etc. If necessary, a third line of verification can be set up by the use of certified reference materials (or spiking materials), or through collaborative trials. These procedures are based on external cooperation. External audit procedures and complaints handling procedures are also part of this third line of verification. 

In this type of analysis, the result must be obtained rapidly as a strategy of feedback is used to optimize or to ensure the stability of the operation. The on-line analyser can control the procedure either up or down stream of the reactor (Figure 21.9). 

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. ... 

As an attempt to simulate real operating conditions of automotive converters, a laboratory bench has been designed and ageing procedures determined to reproduce simultaneous chemical and thermal modifications encountered by catalysts in the exhaust line. Characterization of commercial samples after ageing according to different temperature cycles evidences formation of both platinum/rhodium alloys and cubic perovskite-type compound, CeA103. Simultaneously with the formation of cerium aluminate, a thermal stabilization of catalysts is observed, in terms of mean noble metal particles size and concentration of rhodium in alloyed phases. An interpretation based on the crystallographic adaptation of alumina, cerium aluminate and ceria is proposed. 

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