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Solvent-evaporation, solvent extraction and spray drying for polylactide microsphere preparation.
No full textEvaluation of official instrumental methods for the determination of particulate matter contamination in large volume parenteral solutions
No full textAbstractThe distribution pattern of particle contamination in nine different types of LV parenteral solutions and the possibility of correlating the counts made with two official instruments (Coulter Counter and HIAC) were studied. Two hundred containers of LV parenteral solutions (corresponding to 40 batches) produced in Italy, were sampled. Each bottle was submitted to HIAC and Coulter Counter countings, for particle sizes ranging between 2 and 25 μm. For about 50% of the products, the two straight lines that represent the distribution of particle contamination obtained with the two methods did not cross-over within the studied size range, the Coulter Counter counts always proving higher than the HIAC ones. In the other cases, the cross-over point of the two lines occurred at varying size levels. Statistical analysis of the results pointed to a relationship between the contamination values obtained with the two counting methods for sizes ranging between 2 and 5 μm, but there was no correlation for sizes equal to, or higher than, 10 μm. From the maximum contamination levels established by the BP and the FU IX for the HIAC method, the corresponding values were calculated for the Coulter Counter method. Similarly the values were calculated the HIAC method based on the maximum values set for the Coulter Counter.</jats:p
Evaluation of the influence of open and closed-ampoule technologies on particulate matter in small-volume parenterals
No full textSVP in glass ampoules are manufactured using two main different technological production processes: the open-ampoule process (O) and the closed-ampoule process (C). In principle, the open-ampoule production technology should lead to better controlled production process. To test this hypothesis and quantify the possible qualitative differences in the manufactured ampoules, a suitable experimental design was set up. The two ampoule production processes have been compared on the basis of the visible particulate burden. Two batches of ampoules filled with water for injections were produced for each type of process, following conventional industrial procedures. Two samples of 20,000 units were taken from each batch and inspected with different automatic inspection systems: two Brevetti CEA machines (S1, S2-light scattering) and two EISAI machines (S3, S4-light absorbtion). The comparison between the processes was based on the rejection percentage. On both inspection machines the open-ampoule production samples present rejection percentages (ranging from 0.154% to 1.248% rejection percentages) which, on average, are lower than those detected in closed- ampoule production (ranging from 1.434% to 3.86% rejection percentages). The difference between the two processes is even more marked if we also consider the data obtained using inspection machines S3 and S4. The substantial differences in performance of the four inspection machines stress the need to provide for adequate validation procedures
Evaluation of spray-drying as a method for polylactide and polylactide-L-glycolide microsphere preparation
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