Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe

Brazil

Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe

Brazil
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Filho E.S.S.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | Oliveira A.T.C.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | Melo J.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | Lira D.R.C.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | And 4 more authors.
Latin American Journal of Pharmacy | Year: 2013

The use of monitoring techniques based on statistical criteria is a widespread practice, but it is not frequently used in the pharmaceutical industry. Statistical process control is a type of technique used for verifying the behavior of the process. The use of statistical control to monitor the compression stage is valuable to obtain information and develop strategies for process validation, as well as to allow the management of the behavior of the critical variables of the product during the process. The yield was used to identify and quantify losses of the stages of production. The aim of this study was to define the upper and lower yield limits of the stages of the production process through a retrospective study of the batch record. It was used 218 batches of captopril 25 mg tablet from Industry X.


Grangeiro-Junior S.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | Silva I.J.M.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | Silva J.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | de Oliveira M.A.C.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | And 3 more authors.
Revista de Ciencias Farmaceuticas Basica e Aplicada | Year: 2012

In the blister packaging process, the formation of waste is almost inevitable, given the dynamics and type of raw material used in the system. In this study, an analysis of blister waste in the blistering process was carried out in the multipurpose solids Division of a pharmaceutical laboratory, with respect to the type of blister-packing machine used in the process, the characteristics of the product manufactured, the main factors involved in the generation of waste and the amount of waste in the batches analyzed. The SPC tool was used to analyze the results. Despite all the variations found in the graphical analysis of stability and process capacity, all batches complied with the pharmacopeial specifications. However, there is evidence that the process should be improved and could be made more efficient, generating savings for the company.


Oliveira A.T.C.,Federal University of Pernambuco | Santana D.P.,Federal University of Pernambuco | Alencar J.R.B.,UFERSA | Ribas L.A.S.,Laboratorio Farmaceutico Do Estado Of Pernambuco Lafepe | And 4 more authors.
Latin American Journal of Pharmacy | Year: 2012

This work evaluated the cleanliness of equipment involved in manufacturing the product LAFEPE Zidovudine (AZT) + Lamivudine (3TC) 300 mg + 150 mg coated tablets in a antiretroviral plant. A method for simultaneous determination of AZT+3TC in High Performance Liquid Chromatography HPLC-UV is selective and presented a linear range from 2.5 to 15 μg/mL, and Limit of Detection (LOD) (AZT: 0.13 μg/mL; 3TC: 0.15 μg/mL) and Limit of Quantification (LOQ) (AZT: 0.20 μg/mL; 3TC: 0.23 μg/mL). Recoveries of 82.00 and 83.00 % for the active AZT and 3TC, respectively, were obtained with the use of swab on stainless steel surfaces 316L. The method of cleaning and sampling was applied to three consecutive industrial batches and the results met the specification limits for contaminants.

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