[BOOK][B] Sterile filtration: A practical approach

MW Jornitz - 2020 - taylorfrancis.com
This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing
practical applications of universal and dependable operational protocols, integrity testing …

Considerations in sterile filtration. Part II: the sterilizing filter and its organism challenge: a critique of regulatory standards

MW Jornitz, JE Akers, JP Agalloco… - PDA Journal of …, 2003 - journal.pda.org
Considerations in Sterile Filtration. Part II: The Sterilizing Filter and Its Organism Challenge:
A Critique of Regulatory Standards | PDA Journal of Pharmaceutical Science and …

Microscopic characterization of Brevundimonas diminuta in the hydrated state

G Harp, SJ Cho, E Lester, D Rose… - PDA Journal of …, 2015 - journal.pda.org
Brevundimonas diminuta is the organism most commonly used for challenge testing of
sterilizing-grade filter membranes. ASTM F838-05 and PDA Technical Report 26 rely on B …

[HTML][HTML] Evaluación de una estrategia de conservación para Brevundimonas diminuta

N Burguet, N Sierra - Vaccimonitor, 2012 - scielo.sld.cu
Brevundimonas diminuta se reconoce internacionalmente como el microorganismo
estándar para las pruebas de reto bacteriano. El Laboratorio de Control de la Calidad de los …

[DOC][DOC] Brevundimonas diminuta

K Kawamura, MW Jornitz, TH Meltzer - researchgate.net
B. diminuta (ATCC 19146), previously classified as Pseudomonas diminuta, came to serve
as the model organism for pharmaceutical filtration. These microbes suspended in a …

[PDF][PDF] Validación del Proceso de Filtración Esterilizante para una Solución Parenteral de Bajo Volumen

CVB Noriega - biblioteca-farmacia.usac.edu.gt
Cuando se utiliza la filtración como proceso de esterilización, las normas requieren tres
elementos para asegurar la calidad de un filtro esterilizante. El primer elemento, es el uso …

Assessment of a preservation strategy for Brevundimonas diminuta

N Burguet, N Sierra - VacciMonitor, 2012 - medigraphic.com
Brevundimonas diminuta is internationally recognized as the standard micro-organism for
bacterial challenge tests. The Quality Control Laboratory of Liorad Laboratories has a …