Qualification of the water for injection treatment system for GMP

Author(s):  
S.S. Shvarts ◽  
◽  
F.N. Semakin ◽  
A.A. Spiridonova ◽  
◽  
...  

The proper functioning of the water treatment system is a key area of quality assurance in pharmaceutical manufacturing. Qualification of the water for injection treatment system is a complex multi-stage process required a competent approach and careful preparation. The main requirements for the quality of water for injection and the elements of the water treatment system guided by the qualification of such a system are described in this article. The most important aspects of the project, installation, operation and performance qualification are considered. The presented methodological provisions will be useful for pharmaceutical enterprises implementing the good manufacturing practice in terms of qualification of the water for injection treatment system.

Ciencia Unemi ◽  
2018 ◽  
Vol 11 (28) ◽  
pp. 76-87
Author(s):  
Ángela Carreño-Mendoza ◽  
Leonel Lucas-Vidal ◽  
Ernesto Antonio Hurtado ◽  
Renny Barrios-Maestre ◽  
Ramón Silva-Acuña

Con el objetivo de implementar un sistema de tratamiento del agua del tipo filtración de múltiples etapas para el consumo humano en las comunidades Balsa en Medio, Julián y Severino, Ecuador, a nivel de laboratorio se desarrolló un sistema a escala, estructurado por filtrado en arenas+gravas, seguido de filtración con las zeolitas clinoptilolita y mordenita y finalmente se realizó el proceso de cloración. Se empleó el diseño experimental completamente aleatorizado con cuatro repeticiones para los tratamientos. Los resultados indican que en la etapa de filtración en arenas+gravas las variables DBO5; sólidos totales; coliformes fecales y turbiedad, alcanzaron niveles permitidos de acuerdo a las normas establecidas para el agua de consumo humano. El uso de zeolitas del tipo clinoptilolita y/o mordenita como procedimiento para complementar el proceso de filtración, redujo significativamente los tenores de cobre, plomo, hierro, aluminio, cobalto y cromo. El uso del tratamiento con cloro después del filtrado redujo en 87% la presencia de coliformes fecales reduciendo los valores dentro de los rangos permitidos. El sistema de tratamiento de aguas propuesto para las comunidades estudiadas es de fácil operación y mantenimiento, sus costos son aceptables y los insumos requeridos para su implantación están disponibles en el Ecuador. AbstractA scale system was developed with the objective of implementing a multi-stage filtration system of water treatment for human consumption in the communities of Balsa en Medio, Julián and Severino, Ecuador at the laboratory level.  Initially, it was structured by filtering in sands + gravels, followed by filtration with clinoptilolite and mordenite zeolites. Finally, the water chlorination process was carried out. The assay was developed with a completely randomized experimental design with four repetitions. The results indicate that in the filtration stage in sands + gravels, the BOD5 variables, total solids, fecal coliforms and turbidity, reached permitted levels according to the norms established for water for human consumption. The use of clinoptilolite and/or mordenite zeolites as a method to complement the filtration process significantly reduced the copper, lead, iron, aluminum, cobalt and chromium levels. The use of the chlorine treatment after filtering reduced the presence of fecal coliforms by 87%, reducing the values within the permitted ranges. The water treatment system proposed for the communities studied is easy to operate and maintain, its costs are acceptable and the inputs required for its implementation are available in Ecuador.


2018 ◽  
Vol 18 (1) ◽  
pp. 107-115 ◽  
Author(s):  
Kwang-Hee Lee ◽  
◽  
Min-Ho Kim ◽  
Nam-Woo An ◽  
Chul-hwi Park

1988 ◽  
Vol 20 (11-12) ◽  
pp. 117-123 ◽  
Author(s):  
D. van der Kooij ◽  
W. A. M. Hijnen

A K.pneumoniae strain, isolated from a water treatment system, was tested in growth measurements for its ability to multiply at substrate concentrations of a few micrograms per liter. The organism multiplied on mixtures of carbohydrates and amino acids at a substrate concentration of 1 µg of C of each compound per liter. Tests with individual compounds revealed that especially carbohydrates were utilized at low concentrations. The Ks values obtained for maltose and maltopentaose were 53 µg of C/l and 114 µg of C per liter, respectively. The significance of the growth of K.pneumoniae at low substrate concentrations is discussed.


Author(s):  
Hongsik Yoon ◽  
Jiho Lee ◽  
Taijin Min ◽  
Gunhee Lee ◽  
Minsub Oh

Capacitive deionization (CDI) has been highlighted as a promising electrochemical water treatment system. However, the low deionization capacity of CDI electrodes has been a major limitation for its industrial application,...


RSC Advances ◽  
2021 ◽  
Vol 11 (32) ◽  
pp. 19788-19796
Author(s):  
Bramha Gupta ◽  
Rushikesh S. Ambekar ◽  
Raphael M. Tromer ◽  
Partha Sarathi Ghosal ◽  
Rupal Sinha ◽  
...  

The impact of micro and nanoplastic debris on our aquatic ecosystem is among the most prominent environmental challenges we face today.


2008 ◽  
Vol 80 (8) ◽  
pp. 703-707 ◽  
Author(s):  
Steven J. Wright ◽  
Jeremy D. Semrau ◽  
David R. Keeney

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