Batch analysis

Reaction not Verify final batch analysis and conditions before complete before drumming transfer/ drumming. CCPS G-15 CCPS G-22 CCPS G-29 CCPS G-30... 

Since the reliability of gas turbines in the power industry has been lower than desired in recent years because of hot-corrosion problems, techniques have been developed to detect and control the parameters that cause these problems. By monitoring the water content and corrosive contaminant in the fuel line, any changes in fuel quality can be noted and corrective measures initiated. The concept here is that Na contaminants in the fuel are caused from external sources such as seawater thus, by monitoring water content, Na content is automatically being monitored. This on-line technique is adequate for lighter distillate fuels. For heavier fuels, a more complete analysis of the fuel should be carried out at least once a month using the batch-type system. The data should be input directly to the computer. The water and corrosion detecting systems also operate in conjunction with the batch analysis for the heavier fuels. 

Initial Situation An experimental granulation technique is to be evaluated a sample of tablets of the hrst trial run is sent to the analytical laboratory for the standard batch analysis prescribed for this kind of product, including content uniformity (homogeneity of the drug substance on a tablet-to-tablet basis, see USP Section (905)" ), tablet dissolution, friability (abrassion resistance), hardness, and weight. The last two tests require little time and were therefore done first. (Note Hardness data is either given in [kg-force] or [N], with 1 kg = 9.81 Newton). 

Numerous workers have found that measurements of serum lipase activity are useful in the diagnosis of pancreatitis (83, 84, 85). Despite this, serum lipase determinations are not usually performed in clinical laboratories, probably due to inherent problems associated with the conventional methods, based on an emulsified lipid substrate. The methods are also not very suitable for manual batch analysis nor for automation due to laborious post incubation procedures. 

The effect of collecting batches depends on the shortening of the analysis time by batch analysis and the time needed to collect the batches. 

J.G. Vollenbroek and B.G.M. Vandeginste, Some considerations on batch arrival and batch analysis in analytical laboratories. Anal. Chim. Acta, 133 (1981) 85-97. 

Describe the quality control procedures required, frequency of QC checks during batch analysis, pass/fail criteria, action to take in the event of a failure. Cross-reference to the relevant sections above. 

There are four different drug products under Part II chemical active substance(s), radiopharmaceutical products, biological medicinal products, and vegetable medicinal products. For example, the GMP production report for biological medicinal products includes description of the genes used, strain of cell line, cell bank system, fermentation and harvesting, purification, characterization, analytical method development, process validation, impurities, and batch analysis (GMP production of biopharmaceuticals is described in Chapter 10). A DMF (Exhibit 8.8) is submitted. 

Abstract Removal of catechol and resorcinol from aqueous solutions by adsorption onto high area activated carbon cloth (ACC) was investigated. Kinetics of adsorption was followed by in-situ uv-spectroscopy and the data were treated according to pseudo-first-order, pseudo-second-order and intraparticle drfiusion models. It was fotmd that the adsorption process of these compotmds onto ACC follows pseudo-second-order model. Furthermore, intraparticle drfiusion is efiective in rate of adsorption processes of these compoimds. Adsorption isotherms were derived at 25°C on the basis of batch analysis. Isotherm data were treated according to Langmuir and Freundhch models. The fits of experimental data to these equations were examined. 

However, the ICH guidelines do not include information about conducting or interpreting impurity studies, except to state that stability studies, chemical development studies, and routine batch analysis should be used to predict the impurities likely to occur in commercial production. 

All the methods described above have been amenable to continuous monitoring as the reaction proceeded. In this section the batch procedure is described, in which aliquots of the reaction mixture are removed at various times and analyzed. Although the batch method is tedious it must be used to study certain exchange reactions and when the quenched-flow technique is used (Sec. 3.3.2). Recent events have suggested that batch analysis of a reacting system may give vital information not easily obtained by routine spectral analysis, see the next section. 

EMEA Comparative table of current and proposed specifications. Batch analysis data on two production batches for all tests in the new specification. Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable. Minor change type IB requires approval... 

Data to identify the active constituent, its chemical and physical properties, formulation composition, batch analysis and stability, process chemistry, analytical methods, and quality control... 

The nature and amounts of these impurities are regulated by specifications that are enforced by batch analysis during color additive certification (192,195). 

Before laboratory QC checks are discussed, we need to revisit the concept of batch analysis introduced in Chapter 4.3. Laboratories process samples in a batch manner by assembling sets of samples that are prepared and analyzed together. Batch analysis enables laboratories to maximize sample throughput while performing a minimum of the required laboratory QC checks. 

Radionuclides involved in manufacturing radiopharmaceuticals must be considered as starting materials. For very short-lived radionuclides, where batch analysis is not possible, the validation of the production process of the radionuclide is of utmost importance. 

A number of valuable methods of analysis are essentially batch processis themselves and cannot be operated on a continuous basis. Their use in an on line mode will then require frequent sampling and rapid presentation of the sample to the instrument followed by rapid analysis. It may be necessary to use a battery of analysers working in parallel to cope with the number of samples presented. A particularly important example of batch analysis is the use of gas-liquid chromatography. The power of this technique to provide rapid analysis of complex mixtures has led to its use for "monitoring many organic processes, and its integration into many chemical plants. 

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