Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat

In the present study, the feasibility to employ the in vitro pyrogen test (IPT) in the validation of depyrogenation process is presented. As one of the main advantages of IPT is its ability to determine pyrogen absorbed to the container surface, direct incubation of diluted whole blood with the endo...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Perdomo Morales, Rolando, Spreitzer, Ingo, Montero Alejo, Vivian, Loeschner, Bettina, Montag-Lessing, Thomas
Formato: Articulo
Lenguaje:Inglés
Publicado: 2009
Materias:
Farmacia
depyrogenation; endotoxin; in vitro; pyrogen; validation; whole blood
Toxinas Bacterianas
Técnicas y Procedimientos de Laboratorio
Sustancias Nocivas
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/7729
http://www.latamjpharm.org/trabajos/28/1/LAJOP_28_1_1_12_1SV67H10NX.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-7729
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
depyrogenation; endotoxin; in vitro; pyrogen; validation; whole blood
Toxinas Bacterianas
Técnicas y Procedimientos de Laboratorio
Sustancias Nocivas
spellingShingle Farmacia
depyrogenation; endotoxin; in vitro; pyrogen; validation; whole blood
Toxinas Bacterianas
Técnicas y Procedimientos de Laboratorio
Sustancias Nocivas
Perdomo Morales, Rolando
Spreitzer, Ingo
Montero Alejo, Vivian
Loeschner, Bettina
Montag-Lessing, Thomas
Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat
topic_facet Farmacia
depyrogenation; endotoxin; in vitro; pyrogen; validation; whole blood
Toxinas Bacterianas
Técnicas y Procedimientos de Laboratorio
Sustancias Nocivas
description In the present study, the feasibility to employ the in vitro pyrogen test (IPT) in the validation of depyrogenation process is presented. As one of the main advantages of IPT is its ability to determine pyrogen absorbed to the container surface, direct incubation of diluted whole blood with the endotoxin indicator was first attempted. It was not possible to quantify the endotoxin in control indicators due to the high content, which is discussed. However, it was possible to demonstrate that indicators subjected to the depyrogenation process were indeed pyrogen free, a quality that is difficult to assure when the LAL assay is employed in extract of indicators or medical devices. On the other hand, IPT performed as well as LAL when endotoxin was previously extracted from the indicator surface. Finally, some conditions for incubation of whole blood with the test surface and to dilute the supernatant obtained from the incubation are presented.
format Articulo
Articulo
author Perdomo Morales, Rolando
Spreitzer, Ingo
Montero Alejo, Vivian
Loeschner, Bettina
Montag-Lessing, Thomas
author_facet Perdomo Morales, Rolando
Spreitzer, Ingo
Montero Alejo, Vivian
Loeschner, Bettina
Montag-Lessing, Thomas
author_sort Perdomo Morales, Rolando
title Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat
title_short Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat
title_full Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat
title_fullStr Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat
title_full_unstemmed Using the In vitro pyrogen test in the validation of depyrogenation process by Dry-Heat
title_sort using the in vitro pyrogen test in the validation of depyrogenation process by dry-heat
publishDate 2009
url http://sedici.unlp.edu.ar/handle/10915/7729
http://www.latamjpharm.org/trabajos/28/1/LAJOP_28_1_1_12_1SV67H10NX.pdf
work_keys_str_mv AT perdomomoralesrolando usingtheinvitropyrogentestinthevalidationofdepyrogenationprocessbydryheat
AT spreitzeringo usingtheinvitropyrogentestinthevalidationofdepyrogenationprocessbydryheat
AT monteroalejovivian usingtheinvitropyrogentestinthevalidationofdepyrogenationprocessbydryheat
AT loeschnerbettina usingtheinvitropyrogentestinthevalidationofdepyrogenationprocessbydryheat
AT montaglessingthomas usingtheinvitropyrogentestinthevalidationofdepyrogenationprocessbydryheat
bdutipo_str Repositorios
_version_ 1764820486465781762

Ejemplares similares