Pharma Pleated Fiberglass Depth Cartridge Filters

Product catalog summary

Overview: The document details the specifications and applications of Pharmaceutical Grade PGD Cartridge Filters, which utilize pleated fiberglass depth media. These filters are designed to meet FDA requirements and are used in various pharmaceutical applications for bioburden reduction.

Specifications: The filters are composite media cartridges with a polypropylene layer to ensure fiber-free effluent. They are rinsed with high purity water and have a 99% retention rate at the rated pore size. The construction materials include pleated fiberglass, polypropylene, and polyester, with thermal bonding sealing methods. O-rings are available in various materials such as Buna, Viton, and Silicone.

Applications: These filters are suitable for diagnostics, biologicals, medications, water, bulk pharmaceutical chemicals, ophthalmics, buffers, and other media.

Dimensions and Filtration Area: The cartridges range from 5 to 40 inches in length with a nominal outside diameter of 2.75 inches. The filtration area is 5.8 ft² per 10-inch length.

Integrity and Operating Parameters: All cartridges are factory tested for integrity. Maximum operating parameters include a forward differential pressure of 50 psid at 20°C and a reverse pressure of 40 psid. The operating temperature is 82°C at 10 psid in water, with a recommended changeout pressure of 35 psid.

Sanitization and Sterilization: The filters can be sanitized using filtered hot water, autoclave, or in-line steam, with specific conditions for each method. Chemical sanitization can be performed using standard industry chemicals.

Compliance and Quality Assurance: The filters comply with USP Biosafety and FDA regulations, ensuring non-toxicity and low levels of bacterial endotoxins. They are manufactured in an ISO 9001:2008 certified facility, with traceability ensured through lot codes.

Flow Rate: The document provides a table of typical flow rates for various pore sizes, indicating the water flow rates through a single 10-inch cartridge at 1 psid pressure differential.

Ordering Information: The document includes a detailed guide on ordering, with variables such as pore size, end cap type, and O-ring material.

Catalog excerpts

Pharma Pleated Fiberglass Depth Cartridge Filters-1

PGD Cartridge Filters Pleated Fiberglass Depth Media Buffers and Other Media Dimensions Length Outside Diameter Construction Materials Filtration Media Pleated Fiberglass and Polypropylene Composite Depth Media Media Support Support Components Filtration Area PGD Depth Filter Cartridges are designed to meet FDA requirements. Our pharmaceutical grade fiberglass depth media cartridges are composite media cartridges containing a final downstream layer of polypropylene media to ensure fiber free effluent. These cartridges have been rinsed with high purity water to remove manufacturing debris from the product. They are rated at 99% retention at the rated pore size. The cartridge offers the benefits of high contaminant holding as well as excellent retention. These high capacity cartridges are used in pre‑filter applications as well as final filter applications where the goal is bioburden reduction and not sterile product. (Average - area varies with media thickness and porosity) Integrity Test Information All filter cartridges are factory tested for integrity before shipment. Field duplication of these tests is not practical because of the absence of commercial portable testing equipment. Maximum Operating Parameters Differential Pressure • Forward Operating Temperature Recommended Changeout Pressure 82 °C (180 °F) at 10 psid (0.69 bard) in water. 35 psid (2.4 bard) Sanitization/Sterilization Filtered Hot Water 90 °C (194 °F), 30 minutes, multiple cycles, max 3 psid forward flow Outer Support Cage In-line Steam Sealing Method Thermal Bonding Buna, Viton® (or FKM), EP, Silicone, FEP Encapsulated Silicone, FEP Encapsulated Viton (or FKM) For all elevated temperature procedures above, a stainless steel support ring is required. Total Performance Critical Process Filtration, Inc. is a vertically integrated manufacturer of filtration products to industries in which filtration is considered a critical part of the manufacturing process. We supply a complete line of products and services to help you cost effectively satisfy all your filtration requirements from a single source. Chemical Sanitization Performed using industry standard concentrations of hydrogen peroxide, paracetic acid, sodium hypochlorite and other selected chemicals. Pharmaceutical Grade

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Pharma Pleated Fiberglass Depth Cartridge Filters-2

The materials used to construct pharmaceutical grade GD cartridge filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. GD cartridge filters comply with Title 21 CFR sections 210.3 (b)(6 and 211.72, for non-fiber releasing filters. The levels of bacterial endotoxins in aqueous extracts from pharmaceutical grade cartridge filters are below current USP limits as specified for water for injection. Quality Assurance and...

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