Small containers quality control manufacturer

The manufacture of biological products, unlike that of pharmaceuticals, uses materials that present variability. The active substance is generally produced in small quantities and needs to be separated from complex mixtures containing several types of contaminants. Lots are generally small and quality control tests are usually based on biological techniques that present higher variability than physicochemical assays. The processes are also susceptible to microbial contamination. The in-process controls are of fundamental importance to detect quality deviations that cannot be assessed through assays performed only on the final products. 

Quality control tests or improvement of existing processes. Raw materials from various sources can be used in the manufacture of fine chemicals and pharmaceuticals. The raw materials can contain different impurities at various concentrations. Therefore, before the raw material is purchased and used in a full-scale batch its quality should be tested in a small-scale reactor. Existing full-scale procedures are subject to continuous modifications for troubleshooting and for improving process performance. Laboratory reactors used for tests of these two kinds are usually down-scaled reactors or reactors being a part of the full scale-reactor. 

If this comparison of the selectivity of different columns does indeed demonstrate that the observed difference correlates with a difference in the batch of packing material, then there are two possible solutions to the problem. One possibility is to reserve a quantity of bulk packing or packed columns specifically for the customer or even at the customer s site. This is the best solution if the separation is needed only for a limited amount of time. If, on the other hand, the separation will be needed for many years to come, as is often the case with quality control methods, it is better to redevelop and harden the method. Often, only a small change in the mobile phase conditions is necessary to solve the problem. N ow that everybody is aware of the potential differences in the method on different batches of packing, one should check the reproducibility on several new batches of packing. Several column manufacturers offer reproducibility test kits that contain several different batches of packing and enable such studies. 

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