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Sterile Filtration
Maik W. Jornitz (eds.)
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Disponibilidad
Institución detectada | Año de publicación | Navegá | Descargá | Solicitá |
---|---|---|---|---|
No detectada | 2006 | SpringerLink |
Información
Tipo de recurso:
libros
ISBN impreso
978-3-540-28625-7
ISBN electrónico
978-3-540-33018-9
Editor responsable
Springer Nature
País de edición
Reino Unido
Fecha de publicación
2006
Información sobre derechos de publicación
© Springer-Verlag Berlin Heidelberg 2006
Cobertura temática
Tabla de contenidos
doi: 10.1007/b104242
Types of Filtration
Richard V. Levy; Maik W. Jornitz
There are a multitude of filter designs and mechanisms utilized within the biopharmaceutical industry. Prefilters are commonly pleated or wound filter fleeces manufactured from melt-blown random fiber matrices. These filters are used to remove a high contaminant content within the fluid. Prefilters have a large band of retention ratings and can be optimized to all necessary applications. The most common application for prefilters is to protect membrane filters, which are tighter and more selective than prefilters. Membrane filters are used to polish or sterilize fluids. These filters need to be integrity testable to assess whether or not they meet the performance criteria. Cross-flow filtration can be utilized with micro- or ultrafiltration membranes. The fluid sweeps over the membrane layer and therefore keeps it unblocked. This mode of filtration also allows diafiltration or concentration of fluid streams. Nanofilters are commonly used as viral removal filters. The most common retention rating of these filters is 20 or 50 nm.
Pp. 1-26
doi: 10.1007/b104243
Modus of Filtration
Theodore H. Meltzer
Experience teaches that particles larger than the pores of a filter cannot negotiate its passage. Other retention mechanisms are less obvious than sieve retention or size exclusion. They are electrical in nature, and find expression in the bonding alliances that mutually attract (or repel) filters and particles. The influence of hydrogen bonds, of van der Waals forces, of hydrophobic adsorptions, and of transient polarities on particle retentions are set forth in terms of the double electrical layer concept that also governs colloidal destabilizations. The origins of differences in membrane porosities is explained, as also the importance of the filtration conditions. The singularity of the particle-fluid-filter relationship on organism and/or pore size alteration is stressed.
Pp. 27-71
doi: 10.1007/b104245
Microfiltration Membranes: Characteristics and Manufacturing
Oscar W. W. Reif
Membrane filtration is used within a multitude of processes ranging from dialysis to desalination processes to sterilizing filtration in the pharmaceutical industry. Membranes, nevertheless, have to have special characteristics and properties to serve such specific applications. Microfiltration membranes are utilized in a large range of membrane polymers and structures, which all have individual production process steps to achieve consistently the same membrane parameters. This chapter discusses membrane polymers and production processes in detail.
Pp. 73-103
doi: 10.1007/b104244
Filter Construction and Design
Maik W. Jornitz
Sterilizing and pre-filters are manufactured in different formats and designs. The criteria for the specific designs are set by the application and the specifications of the filter user. The optimal filter unit or even system requires evaluation, such as flow rate, throughput, unspecific adsorption, steam sterilizability and chemical compatibility. These parameters are commonly tested within a qualification phase, which ensures that an optimal filter design and combination finds its use. If such design investigations are neglected it could be costly in the process scale.
Pp. 105-123
doi: 10.1007/b104246
Filter Validation
Russell E. Madsen
Validation of a sterilizing filtration process is critical since it is impossible with currently available technology to measure the sterility of each filled container; therefore, sterility assurance of the filtered product must be achieved through validation of the filtration process. Validating a pharmaceutical sterile filtration process involves three things: determining the effect of the liquid on the filter, determining the effect of the filter on the liquid, and demonstrating that the filter removes all microorganisms from the liquid under actual processing conditions.
Pp. 125-141
doi: 10.1007/b104248
Integrity Testing
Maik W. Jornitz
To ensure that sterilizing grade filters in aseptic processing worked as required, such filters are integrity tested. Integrity tests, like the bubble point, diffusive flow or pressure hold test, are non-destructive tests, which are correlated to a destructive bacteria challenge test. This correlation verifies the integrity test limits the filters have to pass. Integrity tests are required by regulatory authorities. The post filtration integrity test is a must, pre filtration integrity testing is recommended. The different tests have specific limitations therefore there is no overall, best integrity test, which can be utilized for every filtration system.
Pp. 143-180