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SeraPES-Cap Single Layer Sterilizing Grade 0.2 Micron PES Membrane Capsule Filter Sterilizing Grade 0.2 Micron PES Membrane Capsule Filter Serene validated PES Pharmaceutical Grade Filters are designed for product sterility and ease of wettability for final aseptic filtration in biopharmaceutical. This validated 0.2um PES filter combine two asymmetric polyethersulfone (PES)membrane layers with new innovative Advanced Pleat Technology design. This combination results in a robust filter that is optimized for both high throughput and fast flow applications. SERENE PES filter exhibits low protein binding and excellent drug compatibility to maximize recovery of critical media components. It’s double layer membrane configuration makes it ideally suited for final filtration in critical applications especially those involving fluid at high temperature. The unique hydrophilic polyethersulfone membrane wets easily for integrity testing and is ideal for applications where low protein binding is critical. Advance Membrane Technology SERENE validated filters incorporate two layers of polyethersulfone membrane. The upstream layer is highly asymmetric and provides optimized prefiltration capacity for the downstream layer that contains a robust, centrally located, retention zone. Both membrane layers are asymmetric and together result in a filter with multiple filtration zones providing extremely high contaminant capacity, fast flow rates and reliable sterilizing filtration performance. This design technology maximizes the useful surface area of the filter while maintaining open flow paths between media pleats. This new technology provides those membrane surface properties that are responsible for the outstanding wettability and low protein binding character of the SERENE PTFE Membrane, even after extreme thermal and chemical stress,allowing e.g. multiple cycles of wet and dry steaming in both directions without affecting wettability and integrity testing. Microbial Challenge Testing of Filters Filters used in the production of sterile products are always less than or equal to 0.2um pore size rating. This physical characteristic is always a primary requirement for a filter to be considered acceptable for use in the production of a sterile product stream. Further confirmation of a filter’s suitability is established by means of the challenge with B. diminuta discussed previously in this chapter. The FDA has defined a proper challenge as one that confronts every square centimeter of the available filtration area with 1x 107 CFU of this model organism. As previously mentioned, it is important to consider that this challenge test does not confirm the unequivocal ability of a filter to produce a process stream that is always free of microbial contamination. The true mission of the filter is to adequately abate microbiological risk in terms of infection of the end user, absolute sterility being impossible to establish by this or any other widely applied test including the so-called “sterility test.” The sterility test is of course, itself often dependent upon filter sterilization. Protein Adsorption by Sterilizing Grade Filters The adsorption of proteins onto polymeric filters is of considerable practical interest. The technique of preparing new drugs by way of fermentation processes includes their downstream purification by separation procedures such as filtration or liquid–solid chromatography. Separation of the extracellular products from the cell remnants is achieved by filtration in a clarification step; microporous membranes are employed. The debris is retained by the filter; the effluent contains the desired proteins. Ultrafiltration by way of tangential flow operations is a technique often used to concentrate the sought-after products. Alternatively, liquid-solid chromatography is utilized to bond the proteinaceous products to a carrier surface. Subsequently, the desired (protein) product is released in purer form. Purifying activities based on filters can be complicated by blockage of the filter pore caused by protein and/or other depositions. The same may result when preparations containing proteins undergo filtrations designed for sterilizations, and for virus removal. The hindrance of the filtration process by protein adsorption is termed “fouling” a word whose pejorative implication is one of unwelcome interference. Actually, fouling is a poorly understood phenomenon. Protein adsorptions studies are undertaken in pursuits of its amelioration. The loss of time and effort attendant upon a filter blockage translates to a monetary loss. An even greater direct loss may occur when valuable proteins, the product of present biochemical efforts, are irreversibly adsorbed to a filter to become discarded with it. The strong interest in securing high yields of high-value proteins is self apparent. The adsorptive strength of a membrane is, thus, expressible in terms of its adsorption to a specific protein, both in terms of the quantity of protein it binds to the point of saturation, and in the extent available for adsorption beyond the point of contact. Scalability Serene sterilizing grade filter is available to meet your scale up process needs from R&D to production scale. This range includes disposable capsules, mini-cartridges and full size cartridges. In addition, filter discs are available when even smaller membrane surface area is required. Validation of the Filter and of the Filtration Process The validation of sterilizing filtrations, and of the sterilizing filters involved is critical to the production of a sterile drug product, or of a sterile active pharmaceutical ingredient (API). The sterility of the drug preparation cannot be ascertained by analysis of its samples. It is impossible to test every drug container to assess its sterility. Similarly, a statistical determination of sterility would require so large a sampling as to be impractical. Validation of a process provides the assurance that its product is sterile. Such validation is a regulatory requirement (FDA, 1985). Validation of the filters used to achieve a sterile API is also necessary. It serves to assure that they perform in the manner intended; this may also be a regulatory requirement if there are no further sterilizing steps for the ingredient after its being formulated into the final product. Validation of a sterilizing filtration process used for pharmaceutical liquids essentially involves three things: determining the effect of the liquid on the filter, determining he effect of the filter on the liquid, and demonstrating that the filter removes all microorganisms from the liquid under actual processing conditions, resulting in a sterile filtrate (Madsen, 2006). One further point may need to be considered, namely, the interaction among the contaminating organisms, the solution, and the filter. Therefore, several studies are necessary to perform a complete filter validation. Such would include investigating extractables, chemical compatibility, initial filter performance, and bacterial retention testing. If the filter is to be post-use integrity tested in product-wet condition then validation of product-wet integrity test specifications is also necessary. Reuse testing is indicated if the intention is to use the filters more than once. This latter practice is not encouraged because of the heightened possibilities of cross-contamination.. Industrial Application • Final 0.2 µm sterilizing filtration • Media and fermenter feed streams • Serum and blood fractions • Biologicals • Vaccines • Chromatography column protection • Cell culture fluids (debris clarification) • High protein feed streams • Parenterals (SVP, LVP) • Reagents and Buffers • Solvent filtration Reagents & Buffers • Ophthalmics • High purity DI water and WFI systems • Bulk pharmaceutical chemicals • Orals and Topicals Features & Benefits • Ensures easy wet out for integrity testing and low protein binding • Easy to wet for a reliable integrity test • Validated 0.2um Membrane for reliable sterilizing filtration • High-strength design allows for multiple autoclave cycles and extended use • High steam cycle lifetimes and long service Benefits • USFDA CFR Title 21 materials of construction, USP Class VI Biological Safety Test, Validation Guide and Drug Master File listing eases validation and regulatory submission • Capsule filters are available in both gamma compatible and sterile formats which Eliminate cleaning and cleaning validation step associated with stainless steel housings for maximal ease-of-use Technical Specification Nominal Dimension Operating Parameter Mean Porosity • 78% END CONNECTION • Triclover (TC) • Hose Barb • NPT EFFECTIVE FILTRATION AREA Sterilization & Autoclaving The filters can be sterilized by autoclaving for up to 25 cycles at 275°F/135°C. The filters can also be sterilized by steam-in-place procedure up to 25 cycles at 127°C (261°F) for 30 minutes at less than 0.3 bar differential pressure. The filters can also sanitized by hot water or common chemicals that are compatible with filter components. Retention Complete retention of > 107 organism/cm² of Brevundimonas (Pseudomonas) diminuta in accordance with the current HIMA challenge methodology (ASTM F838-83). Validation Guide available upon request. Integrity tested All capsules are 100% integrity tested—Validation Guide available upon request. Product validation guide available on request. All SERENE capsules are manufactured under strict control with batch number identification, giving full traceability on all components. Biological Tests • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics • Meets Cleanliness per USP Particulates in Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL) • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water Toxicity All polypropylene components meet the specifications for biological safety per USP Class VI –121˚C for plastics. Food Safety Compliance Materials of construction comply with FDA regulations for food and beverage contact use as detailed in the US Code of Federal Regulations, 21CFR. Materials used to produce filter media and hardware are deemed safe for use in contact with foodstuffs in accordance with EU Directives 1935/2004, and/or 10/2011. Mini PES (10”) Capsule Mini PES (5”) Capsule Mini PES (2.5”) Capsule Ordering Information Drawing and dimensions
Sterilizing Grade 0.2 Micron PES Membrane Capsule Filter Sterilizing Grade 0.2 Micron PES Membrane Capsule Filter
Serene validated PES Pharmaceutical Grade Filters are designed for product sterility and ease of wettability for final aseptic filtration in biopharmaceutical. This validated 0.2um PES filter combine two asymmetric polyethersulfone (PES)membrane layers with new innovative Advanced Pleat Technology design. This combination results in a robust filter that is optimized for both high throughput and fast flow applications. SERENE PES filter exhibits low protein binding and excellent drug compatibility to maximize recovery of critical media components. It’s double layer membrane configuration makes it ideally suited for final filtration in critical applications especially those involving fluid at high temperature. The unique hydrophilic polyethersulfone membrane wets easily for integrity testing and is ideal for applications where low protein binding is critical.
SERENE validated filters incorporate two layers of polyethersulfone membrane. The upstream layer is highly asymmetric and provides optimized prefiltration capacity for the downstream layer that contains a robust, centrally located, retention zone. Both membrane layers are asymmetric and together result in a filter with multiple filtration zones providing extremely high contaminant capacity, fast flow rates and reliable sterilizing filtration performance. This design technology maximizes the useful surface area of the filter while maintaining open flow paths between media pleats. This new technology provides those membrane surface properties that are responsible for the outstanding wettability and low protein binding character of the SERENE PTFE Membrane, even after extreme thermal and chemical stress,allowing e.g. multiple cycles of wet and dry steaming in both directions without affecting wettability and integrity testing.
Filters used in the production of sterile products are always less than or equal to 0.2um pore size rating. This physical characteristic is always a primary requirement for a filter to be considered acceptable for use in the production of a sterile product stream. Further confirmation of a filter’s suitability is established by means of the challenge with B. diminuta discussed previously in this chapter. The FDA has defined a proper challenge as one that confronts every square centimeter of the available filtration area with 1x 107 CFU of this model organism. As previously mentioned, it is important to consider that this challenge test does not confirm the unequivocal ability of a filter to produce a process stream that is always free of microbial contamination. The true mission of the filter is to adequately abate microbiological risk in terms of infection of the end user, absolute sterility being impossible to establish by this or any other widely applied test including the so-called “sterility test.” The sterility test is of course, itself often dependent upon filter sterilization.
The adsorption of proteins onto polymeric filters is of considerable practical interest. The technique of preparing new drugs by way of fermentation processes includes their downstream purification by separation procedures such as filtration or liquid–solid chromatography. Separation of the extracellular products from the cell remnants is achieved by filtration in a clarification step; microporous membranes are employed. The debris is retained by the filter; the effluent contains the desired proteins. Ultrafiltration by way of tangential flow operations is a technique often used to concentrate the sought-after products. Alternatively, liquid-solid chromatography is utilized to bond the proteinaceous products to a carrier surface. Subsequently, the desired (protein) product is released in purer form. Purifying activities based on filters can be complicated by blockage of the filter pore caused by protein and/or other depositions. The same may result when preparations containing proteins undergo filtrations designed for sterilizations, and for virus removal. The hindrance of the filtration process by protein adsorption is termed “fouling” a word whose pejorative implication is one of unwelcome interference. Actually, fouling is a poorly understood phenomenon. Protein adsorptions studies are undertaken in pursuits of its amelioration. The loss of time and effort attendant upon a filter blockage translates to a monetary loss. An even greater direct loss may occur when valuable proteins, the product of present biochemical efforts, are irreversibly adsorbed to a filter to become discarded with it. The strong interest in securing high yields of high-value proteins is self apparent. The adsorptive strength of a membrane is, thus, expressible in terms of its adsorption to a specific protein, both in terms of the quantity of protein it binds to the point of saturation, and in the extent available for adsorption beyond the point of contact.
Serene sterilizing grade filter is available to meet your scale up process needs from R&D to production scale. This range includes disposable capsules, mini-cartridges and full size cartridges. In addition, filter discs are available when even smaller membrane surface area is required.
The validation of sterilizing filtrations, and of the sterilizing filters involved is critical to the production of a sterile drug product, or of a sterile active pharmaceutical ingredient (API). The sterility of the drug preparation cannot be ascertained by analysis of its samples. It is impossible to test every drug container to assess its sterility. Similarly, a statistical determination of sterility would require so large a sampling as to be impractical. Validation of a process provides the assurance that its product is sterile. Such validation is a regulatory requirement (FDA, 1985). Validation of the filters used to achieve a sterile API is also necessary. It serves to assure that they perform in the manner intended; this may also be a regulatory requirement if there are no further sterilizing steps for the ingredient after its being formulated into the final product. Validation of a sterilizing filtration process used for pharmaceutical liquids essentially involves three things: determining the effect of the liquid on the filter, determining he effect of the filter on the liquid, and demonstrating that the filter removes all microorganisms from the liquid under actual processing conditions, resulting in a sterile filtrate (Madsen, 2006). One further point may need to be considered, namely, the interaction among the contaminating organisms, the solution, and the filter. Therefore, several studies are necessary to perform a complete filter validation. Such would include investigating extractables, chemical compatibility, initial filter performance, and bacterial retention testing. If the filter is to be post-use integrity tested in product-wet condition then validation of product-wet integrity test specifications is also necessary. Reuse testing is indicated if the intention is to use the filters more than once. This latter practice is not encouraged because of the heightened possibilities of cross-contamination..
• Final 0.2 µm sterilizing filtration
• Media and fermenter feed streams
• Serum and blood fractions
• Biologicals
• Vaccines
• Chromatography column protection
• Cell culture fluids (debris clarification)
• High protein feed streams
• Parenterals (SVP, LVP)
• Reagents and Buffers
• Solvent filtration Reagents & Buffers
• Ophthalmics
• High purity DI water and WFI systems
• Bulk pharmaceutical chemicals
• Orals and Topicals
• Ensures easy wet out for integrity testing and low protein binding • Easy to wet for a reliable integrity test • Validated 0.2um Membrane for reliable sterilizing filtration • High-strength design allows for multiple autoclave cycles and extended use • High steam cycle lifetimes and long service Benefits • USFDA CFR Title 21 materials of construction, USP Class VI Biological Safety Test, Validation Guide and Drug Master File listing eases validation and regulatory submission • Capsule filters are available in both gamma compatible and sterile formats which Eliminate cleaning and cleaning validation step associated with stainless steel housings for maximal ease-of-use
• 78%
• Triclover (TC)
• Hose Barb
• NPT
The filters can be sterilized by autoclaving for up to 25 cycles at 275°F/135°C. The filters can also be sterilized by steam-in-place procedure up to 25 cycles at 127°C (261°F) for 30 minutes at less than 0.3 bar differential pressure. The filters can also sanitized by hot water or common chemicals that are compatible with filter components.
Complete retention of > 107 organism/cm² of Brevundimonas (Pseudomonas) diminuta in accordance with the current HIMA challenge methodology (ASTM F838-83). Validation Guide available upon request.
All capsules are 100% integrity tested—Validation Guide available upon request. Product validation guide available on request. All SERENE capsules are manufactured under strict control with batch number identification, giving full traceability on all components.
• Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics • Meets Cleanliness per USP Particulates in Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL) • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
All polypropylene components meet the specifications for biological safety per USP Class VI –121˚C for plastics.
Materials of construction comply with FDA regulations for food and beverage contact use as detailed in the US Code of Federal Regulations, 21CFR. Materials used to produce filter media and hardware are deemed safe for use in contact with foodstuffs in accordance with EU Directives 1935/2004, and/or 10/2011.
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