Sterilizing-grade Durapore Multimedia Cartridge Filters

Description

Durapore® Multimedia filters combine a 0.22 µm hydrophilic Durapore membrane with an upstream Milligard® prefilter media, providing sterility assurance, high flow rates and extended throughputs, low extractables, and broad chemical compatibility. The combination of prefiltration media and final sterilizing membrane in one filter results in process compression and improved economics.

Multimedia cartridge filters are ideally suited for processes that require maximum pressure differentials. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.

Regulatory Compliance

Multimedia filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each device is marked with the product name and identifying characteristics.

Multiple Formats Available

A full range of filtration areas is available to suit varying application requirements and a variety of connection options are offered to meet your application and housing requirements.

Specifications

	Per 10-inch Cartridge Filter
Filtration Area, m²
Single Layer Prefilter	0.69
Double Layer Prefilter	0.56
Materials of Construction
Filter	Hydrophilic PVDF
Prefilter	Mixed Cellulose Esters
Structural Components	Polypropylene
Supports	Polypropylene
O-ring	Silicone
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C. Reverse: 3.5 (50) @ 25 °C, intermittent
Integrity Test, Bubble Point	≥3450 mbar (50 psig) air with water
Integrity Test, Air Diffusion
Single Layer Prefilter	≤13.3 mL/min @ 2.75 bar (40 psig) in water
Double Layer Prefilter	≤10.8 mL/min @ 2.75 bar (40 psig) in water
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology
Bacterial Endotoxins	Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
NVR Gravimetric Extractables
Single Layer Prefilter	The extractables level was equal to or less than 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Double Layer Prefilter	The extractables level was equal to or less than 70 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
Sterilization	6 autoclave or SIP cycles of 30 min @ 123 ° C
Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.

Typical Clean Water Flow Rate vs Pressure Drop

Cartridge Filter with Multimedia Durapore 1.2/0.22 µm (CV19)

Cartridge Filter with Multimedia Durapore 0.5/0.22 µm (CV06)

Cartridge Filter with Multimedia Durapore 0.5/0.2/0.22 µm (CVSS)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CV0301TP3	10 (25)
	CV0302TP3	20 (50)
	CV0303TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CV0371TP3	10 (25)
	CV0372TP3	20 (50)
	CV0373TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CVSS01TP3	10 (25)
	CVSS02TP3	20 (50)
	CVSS03TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CVSS71TP3	10 (25)
	CVSS72TP3	20 (50)
	CVSS73TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CVSX01TP3	10 (25)
	CVSX02TP3	20 (50)
	CVSX03TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CVSX71TP3	10 (25)
	CVSX72TP3	20 (50)
	CVSX73TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CV0601TP3	10 (25)
	CV0602TP3	20 (50)
	CV0603TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CV0671TP3	10 (25)
	CV0672TP3	20 (50)
	CV0673TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CVSC01TP3	10 (25)
	CVSC02TP3	20 (50)
	CVSC03TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CVSC71TP3	10 (25)
	CVSC72TP3	20 (50)
	CVSC73TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CV1901TP3	10 (25)
	CV1902TP3	20 (50)
	CV1903TP3	30 (75)

Compare	Catalogue No.	Cartridge Nominal Length, in (cm)
	CV1971TP3	10 (25)
	CV1972TP3	20 (50)
	CV1973TP3	30 (75)

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