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
| 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 | The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 15 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 25 mg per capsule after 24 hours 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 F838-83 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 | The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 50 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 75 mg per capsule after 24 hours 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 F838-83 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
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