Sterile Filtration and Bioburden Control for the Processing of Biologics

APIs, Cell Culture Media, Buffers, Raw Ingredients, Water

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Protecting the bioreactor from unwanted organisms and contaminants

Sterile filtration ensures that everything entering the bioreactor meets requirements to optimize cell culture or fermentation growth. Incorporating prefiltration into this process will protect the life of the sterilizing filters and lower your overall filtration costs. Product solutions are discussed below.

Sterilizing and Bioburden Reduction Filtration in Biopharmaceutical Processes (1)

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Remove impurities before chromatography and assure sterility during final fill

Filtration is a vital component in assuring efficient operation and maximum output of chromatography systems in purification processes. Contaminants to be removed can include endotoxins - charged particles that can prematurely consume resin capacity - and organic or inorganic particles in base solutions, buffer solutions and cleaning solutions used to regenerate the columns between batches. Removing these contaminants optimizes column performance and keeps them operating at the highest level.

Sterile filtration of biologics is a preferred method due to the product's heat sensitivity. To avoid degradation and loss of product during final fill CPF's application engineers work with you to:

Ensure proper testing
Choose the best-performing filter
Configure the filter based on filtration goals

Sterilizing

Sterilizing insurance. Our PPS Filters are recommended for the most stringent and critical applications to insure 100% bacteria retention. This filter’s media consists of two identical, hydrophilic membranes. Pore sizes range from 0.03 to 1.2 µm.

Targeted bacteria retention. DPPS filters deliver custom bacteria retention based on your fluids load. You choose the pore sizes of both the prefilter and final layer to achieve targeted results. The prefilter acts as both a bioburden reduction and particle removing filter.

Sterilizing fluids with high particle loads. CPF’s HPPS Filters handle increased capacity and high particle loads with an integrated prefilter for particle removal and a sterilizing final filter. This dual layer model reduces multiple filtrations into a single step.

Sterilizing & endotoxin removal. The PPC Filter consists of a double layer sterilizing membrane for stringent bacteria retention and it has been positively charged to remove any gram-negative bacteria debris.

Bioburden Reduction

Bioburden reduction, non-sterilizing. BPS Filters reduce microbials in aqueous liquids when sterilizing is not required. These hydrophilic filters are available in single and dual layer configurations with a choice of pore sizes for each layer to provide the right level of retention.

Mycoplasma

Mycoplasma control. When your goal is mycoplasma reduction, all CPF sterilizing filters rated at 0.10 micron will reliably reduce mycoplasma in your fluids. When a validation of >log 7 removal is required, choose any CPF sterilizing filter rated at 0.03 micron.

Tank Vent & Process Gas Filtration

Protecting tank contents and the environment. CPF's PTR Filters are hydrophobic sterilizing filters made with Polytetrafluoroethylene (PTFE) membrane to capture microbials as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators and the environment in the surrounding workspace.

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Clarification & Prefiltration

Clarifying and prefiltering microbials and particulates found in APIs, raw ingredients, cell culture media, buffers and excipients will reduce the contamination load on the final filter. In processing applications where sterile product is critical and final filters carry the greatest cost, CPF prefilters do the bulk of filtration, resulting in:

fewer changeouts
extending the life of your sterilizing filters
lower overall filtration costs

High particle loads. BCWPS Filters, made from CPF's proprietary high capacity PES membrane, excel in protecting downstream filters. With its low binding characteristics, BCWPS filters are used for the clarification and prefiltration of products with high proteins and preservatives. Membrane prefilters, such as the BCWPS offer greater retention than a depth filter.

High flow and particle removal. Our PGD Prefilters are made with pleated fiberglass depth media and have a high contaminant holding capacity while still delivering high flow rates.

Fine particles in water, solvents and chemicals. PPD Prefilters, constructed with pleated polypropylene depth media, are versatile filters offering broad chemical compatibility and high retention of fine particles in a variety of fluids used in pharmaceutical applications.

Heavy solids content and contamination. CPF's HLP Prefilters, constructed with high-loft pleated polypropylene depth media, combine superior filtration capacity with exacting retention of fine particles.

Endotoxin removal. CPF's GPC Filter is a standalone endotoxin removal filter used for the filtration of aqueous fluids that contain negatively charged biological contaminants, such as endotoxin, virus and other cell fragments.