Sterilizing filtration is the process of removing microorganisms from a fluid stream without adversely affecting product. Demonstrate removal of a standard test organism (Brevundimonas diminuta)

2020年5月5日 · Filtration is the preferred method of sterilizing heat-sensitive liquid and gases without exposure to denaturing heat. Rather than destroying contaminating microorganisms, it simply removes them.

Let Sartorius help streamline your sterile filtration process! Discover the most advanced sterile filters from the leaders of membrane filtration.

2024年3月29日 · Filtration is the most popular method to sterilize heat sensitive liquid and gases, without exposure to denaturing temperatures. Instead of killing microorganisms that cause contamination the process simply eliminates them.

2013年1月1日 · Sterile filters are used to filter both the liquids entering the bioreactor (e.g., growth media, antifoam, and bicarbonate additions for pH adjustment) and the gases (e.g., sparge air, vents). Sterile filters are also used to manage bioburden levels throughout the downstream purification process.

Understanding the key elements of sterile filtration, validation, and regulatory guidance for developmental phase drug products is critical to ensuring that the process is properly defined and validated.

Filters are, by definition, designed to separate the wanted (typically an active ingredient) from the unwanted (typically some form of contaminant). When tasked to reduce or eliminate bioburden, they are reliant upon other process components to maintain the state of …

2007年6月13日 · “A sterilizing grade filter is one that sterilizes the drug product.” Filter claims for “sterilizing grade” will continue to be of value to drug manufacturers for selection and product-specific retention validation.

Critical Process Filtration provides multiple filter options for sterilizing and prefiltration. Membrane Materials include PES, Nylon 6,6, and PTFE. PES exhibits low protein binding for use with aqueous solutions. Nylon 6,6 has broad chemical compatibility for solvent filtration.

2021年5月9日 · Sterile filtration is the process of removing microorganisms from a fluid stream without adversely affecting the feedstream. A sterilizing-grade designation is not pore size dependent despite the common industry use of the 0.2-µm descriptor.