Opticap XL and XLT Disposable Capsule Filters with 0.1 µm and 0.22 µm Hydrophilic Durapore Membrane

Description

A trusted name in the industry for over 25 years, Durapore® sterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs. The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.

Opticap XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with pleated Durapore membrane minimizes hold-up volume and reduces production losses.

Regulatory Compliance

Filters with hydrophilic Durapore membrane 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 Opticap XL and XLT capsule 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

Opticap XL 2, 4, 5 and 10 capsule filters with hydrophilic Durapore membrane are available in multiple filtration areas, providing an optimal choice for every application.

Opticap XLT 10, 20 and 30 T-line Capsule Filters with hydrophilic Durapore membrane accommodate series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap XLT into your existing process.

Specifications (return to top)

	Opticap XL 2	Opticap XL 4	Opticap XL 5	Opticap XL 10
Filtration Area, m2	0.09	0.19	0.35	0.69
Materials of Construction
Filter media	Hydrophilic PVDF
Supports	Polypropylene
Structural components	Polypropylene
Vent O-ring	Silicone
Vent/Drain	1/4 in. hose barb with double O-ring seal
Integrity Test, Bubble Point
0.1 µm	≥4830 mbar (70 psig) air with water
0.22 µm	≥3450 mbar (50 psig) air with water
Integrity Test, Diffusion
0.1 µm	—	≤7.5 mL/min @ 3.9 bar (56 psig) in water	≤10 mL/min @ 3.9 bar (56 psig) in water	≤20 mL/min @ 3.9 bar (56 psig) in water
0.22 µm	—	≤5.5 mL/min @ 2.75 bar (40 psig) in water	≤6.6 mL/min @ 2.75 bar (40 psig) in water	≤13.3 mL/min @ 2.75 bar (40 psig) in water
Maximum Inlet Pressure, bar (psid)	5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 3.5 (50) @ 25 °C, intermittent
NVR Gravimetric Extractables	≤10 mg after a 500 mL flush and 24-h static soak in 25 °C water	≤10 mg after autoclaving and 24-h soak in water at controlled room temperature	≤15 mg after autoclaving and 24-h soak in water at controlled room temperature	≤25 mg after autoclaving and 24-h soak in water at controlled room temperature
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤1 L
Bacterial Endotoxins	Aqueous extraction contains <0.5 EU/mL as determined by the LAL test
Bacterial Retention	Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology.
Sterilization	3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Toxicity	Non-toxic per MEM elution ISO® 10993-5
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.

	Opticap XLT 10	Opticap XLT 20	Opticap XLT 30
Filtration Area, m2	0.69	1.4	2.1
Materials of Construction
Filter media	Hydrophilic PVDF
Supports	Polypropylene
Structural components	Polypropylene
Vent O-ring	Silicone
Vent/Drain	1/4 in. hose barb with double O-ring seal
Integrity Test, Bubble Point @ 23 °C
0.1 µm	≥4830 mbar (70 psig) air with water
0.22 µm	≥3450 mbar (50 psig) air with water
Integrity Test, Air Diffusion @ 23 °C
0.1 µm	≤20 mL/min @ 3.9 bar (56 psig) in water	≤40 mL/min @ 3.9 bar (56 psig) in water	≤60 mL/min @ 3.9 bar (56 psig) in water
0.22 µm	≤13.3 mL/min @ 2.75 bar (40 psig) in water	≤26.6 mL/min @ 2.75 bar (40 psig) in water	≤40 mL/min @ 2.75 bar (40 psig) in water
Maximum Inlet Pressure, bar (psid)	5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C. Reverse: 3.5 (50) @ 25 °C, intermittent
NVR Gravimetric Extractables	≤25 mg after autoclaving and 24-h soak in water at controlled room temperature	≤50 mg after autoclaving and 24-h soak in water at controlled room temperature	≤75 mg after autoclaving and 24-h soak in water at controlled room temperature
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤1 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤3 L
Bacterial Endotoxins	Aqueous extraction contains <0.5 EU/mL as determined by the LAL test
Bacterial Retention	Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology.
Sterilization	3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Toxicity	Non-toxic per MEM elution ISO® 10993-5
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

Opticap XL 2 Capsule Filters with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XL 2 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XL 4 Capsule Filter with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XL 4 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XL 5 Capsule Filters with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XL 5 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XL 10 Capsule Filters with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XL 10 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XLT 10 Capsule Filters with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XLT 10 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XLT 20 Capsule Filters with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XLT 20 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XLT 30 Capsule Filters with 0.1 µm Hydrophilic Durapore (KVVL)

Opticap XLT 30 Capsule Filters with 0.22 µm Hydrophilic Durapore (KVGL)

Opticap XL Capsule Legends Refer to Connection Type:
TT = 38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet
FF = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet
HH = 14 mm (9/16 in.) Hose Barb Inlet and Outlet
TH = 38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet
FH = 19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet

Ordering Information  (return to top)

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