Analyzer batch

For some drugs, especially experimental ones, not only is each batch analyzed separately but it can never be combined with other batches. When it is packaged, it is labeled with the batch number and the analysis. For these pharmaceuticals a record must be retained of the complete production history, as well as of the results of all tests. All samples taken from the batch must also be kept. Then, should some odd reaction occur in a patient, all the information about the batch is available to... 

Take samples from the granulation prior to tableting and during tableting (beginning, middle, and end of the pilot batch) analyze the particle size distribution of the samples taken. 

Discrete or batch analyzers In these, each sample preserves its integrity in a vessel transported mechanically to various zones of the analyzer, where the different analytical stages are carried out in a sequential manner. Each sample finally arrives at the detector where the relevant signals are recorded. 

Batch analyzers can be classified according to the manner in which the sample is transferred to the final operation, that is, with or without final transfer of the sample. In analyzers with final transfer, the reaction mixture is transported to the detection system, where the analytical measurement is carried out in a fixed cuvette. In analyzers without final transfer of the reaction mixture, all the stages of the process take place in the same vessel. 

In addition to the retest values associated with the OOS sample, samples from lots or batches analyzed along with the aberrant sample (i.e., within the same analytical run) should also be evaluated since they may have been affected by the same errant factor that produced the OOS result. The fact that an accompanying sample passed specification while another failed may be only a result of serendipity. One practice employed by several industrial laboratories is to retest samples that bracketed (surrounded) the OOS sample in the original analytical run. Although the initial results from these... 

To avoid bottlenecks in the analysis, each step should be automated. Automation of data acquisition is achieved by automated HPLC/UV/MS/ ELSD instruments, equipped with autosamplers that allow compounds to be batch analyzed in unattended fashion. Recently, fast generic HPLC methods have been implemented for analysis of combinatorial libraries [33 53]. 

Ping L, Dasgupta PK. 1990. Determination of urinary mercury with an automated micro batch analyzer. Anal Chem 62(l) 85-88. 

Summary information on the stability studies conducted on a drug product are to include conditions tested, batches analyzed, and analytical procedures used. A brief discussion of the results and conclusions, with respect to storage conditions and shelf life, from drug product stability studies and an analysis of the data is to be provided. Tables and graphs should be used where appropriate to describe stability data. A brief description of the postapproval stability protocol for a drug product is to be included. 

L.F. Almeida, M.G.R. Vale, M.B. Dessuy, M.M. Silva, R.S. Lima, V.B. Santos, et al., A flow-batch analyzer with piston propulsion applied to automatic preparation of calibration solutions for Mn determination in mineral waters by ET AAS, Talanta 73 (2007) 906. 

The issue of reproducibility of process parameters and of achievable product quantity and quality is of highest significance as this will ultimately be evaluated by the regulatory agencies. For Investigational New Drug applications (IND) and Process Licence Applications (PLA), rather specific requirements must be met with respect to the minimal number of product batches analyzed. For INDs, no less than three product runs are recommended. Shorter batch processes (5-7 days) have... 

In a batch analyzer, each discrete sample is assigned a container (sample cup or sample bag), within which it is held through all the steps necessary to perform the analysis. The advantage of this approach is that crosscontamination between samples is not possible the samples preserve their identity and cannot be mismatched, since each container carries an identification label. The disadvantage of all batch analyzers is that they are mechanically very complex, have many moving parts that may become worn, and include components that must be precisely machined therefore, they have limited lifetimes. Three types of batch analyzers have been suggested [1.2-1.4]. 

To summarize, air-segmented continuous-flow systems, similarly to batch analyzers, emulate manual solution handling, since these systems rely on attaining steady state and homogeneous mixing. 

Parallel Fast. Parallel-fast analyzers are a special variation of batch analyzers, based on the use of a centrifuge. They are sometimes called centrifugal fast analyzers. The principle is illustrated in Figure 24.13. A central, removable... 

Batch Analyzers. The American Monitor Programachem 1040 does one test at a time on up to 89 samples at up to 15 results per minute. A prepunched program card automatically sets virtually all of the system variables for each method on insertion into the instrument card-reader. A second-generation instrument, the KDA, was shown in 1975. This provides an integrated system from request slip to report form, with a design heavily dependent on the dedicated minicomputer. Another feature offered is graphics, which allows an oscilloscopic display of calibration curves, kinetic reaction-curves, quality-control points, etc. 

The first attempts for automation of solution handling which made up the bulk of labour in an analytical laboratory was simply mechanizing and simulating the traditional batch operations under a conveyer-belt concept. This was an approach which proved to be cost effective and efficient enough to gain widespread acceptance. Batch analyzers which were more successful include the Dupont sample bag" analyzers and the parallel centrifugal analyzers. They are, however, expensive devices, and their use is rather limited, moreover, they are not designed to perform separations. 

Analyze a bacteria sample (including having completed a DOC) Enter bacteria resrrlts after reading a sample batch Analyze a sample for pH (including having completed a DOC) Autoclave samples... 

Grunhut, M., V. L. Martins, M. E. Centurion et al. 2011. Flow-batch analyzer for the chemiluminescence determination of catecholamines in pharmaceutical preparations. Anal. Lett., 44 67-81. 

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