Pharma PES Capsules

Pharma PES Capsules

Pharma PES Capsules

Product catalog summary
Overview: The document provides detailed specifications and applications for Pharmaceutical Grade PPS Capsule Filters, which utilize a double-layered Polyethersulfone (PES) membrane. These filters are designed for critical sterilizing filtration applications in the pharmaceutical industry.
Construction Materials: The filters are constructed using polypropylene for the housing, media support, end caps, center core, and outer support cage. The sealing method employed is thermal bonding.
Applications: PPS Capsule Filters are suitable for diagnostics, biologicals, vaccines, WFI water, large volume parenterals (LVPs), small volume parenterals (SVPs), and ophthalmics. They are particularly effective for filtering products containing preservatives and proteins due to their low adsorption characteristics.
Operating Parameters: The filters can operate at a maximum liquid pressure of 80 psi and gas pressure of 60 psi at 20°C. The maximum operating temperature is 43°C at 30 psi in water. Recommended changeout pressure is 35 psid.
Pore Sizes and Flow Rates: The filters are available in pore sizes ranging from 0.03 μm to 1.2 μm, with corresponding flow rates provided in both GPM and LPM.
Sanitization and Sterilization: PPS capsules can be autoclaved at 250°F for 30 minutes and are compatible with chemical sanitization using industry-standard chemicals. They are available in both pre-sterilized and non-sterilized forms.
Compliance and Safety: The materials used comply with USP Class VI standards and FDA regulations for repeated food contact. The filters are validated for bacterial retention and meet ISO 9001:2008 quality standards.
Ordering Information: The document provides a detailed guide for ordering, including options for pre-sterilization, micron rating, length, and inlet/outlet configurations.
Quality Assurance: Critical Process Filtration ensures high-quality production through real-time monitoring and ISO-certified processes, with each filter assembly undergoing integrity testing before release.
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Catalog excerpts

Pharma PES Capsules-1

PPS Capsule Filters Double Layered Polyethersulfone Membrane PPS Capsules are hydrophilic and manufactured with the highest quality asymmetric polyethersulfone membrane, double layered for extra security. Polyethersulfone (PES) membrane exhibits excellent flow rates with high throughput. PPS capsules are used for sterilizing filtration, the most critical applications in the pharmaceutical industry. PPS capsule elements are 100% integrity tested during production. Validated for use in multiple pharmaceutical applications Excellent flow rates with high throughput Integrity testable Designed for minimal leachables and extractables Low adsorption of proteins and preservatives Flow Rate / Filtration Area The following table represents typical water flow at a one psi (69 mbar) pressure differential across a single 2 inch capsule with 1.0 ft² (930 cm²) of media with 1/2” FNPT ports. The test fluid is water at ambient temperature. Higher pressure drops are acceptable, but as flows increase the pressure drop of the housing becomes more apparent. Pore Size * For approximate flow rates for 5” through 30” capsules, refer to the appropriate cartridge data sheet Construction Materials Housing Filtration Media Double Layered Polyethersulfone (PES) Membrane Media Support Center Core Outer Support Cage Sealing Method Thermal Bonding Specific applications for PPS capsule filters are final, sterilizing filtration of USP Water for Injection (WFI), diagnostic solutions, vaccines, ophthalmics, SVPs, LVPs and biological products. Polyethersulfone is particularly suited for the filtration of products that contain elements that can adsorb to the media, such as preservatives and proteins. The lower binding characteristics of polyethersulfone (PES) make it a good choice for filtration of valuable protein solutions such as vaccines and biologicals as well as ophthalmic solutions. PPS Capsule Filters - Filtration Area Media PES Membrane Maximum Operating Parameters Liquid Operational Pressure Gases Operational Pressure Operating Temperature Forward Differential Pressure 50 psid (3.4 bard) at 20 °C (68 °F) Reverse Differential Pressure Recommended Changeout Pressure Pharmaceutical Grade

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Pharma PES Capsules-2

Integrity Test Specifications - Diffusion Pore Size 0.03 μm 0.10 μm 0.22 μm 0.45 μm 0.65 μm 0.8 μm 1.0 μm 1.2 μm Integrity Test Specifications - Bubble Point Bubble Point (water wetted membrane) 0.03 μm ** 0.10 μm ** 0.22 μm 50 psig (3.5 barg) 0.45 μm 25 psig (1.7 barg) 0.65 μm 19 psig (1.3 barg) 0.8 μm 15 psig (1.1 barg) 1.0 μm 10 psig (0.7 barg) 1.2 μm 9 psig (0.6 barg) ** Test pressure exceeds operational limits of capsule filters. Use the diffusion test method. Pore Size PPS cartridges are validated using test procedures that comply with the intent of both ASTM F 838-05 and HIMA protocols...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.