Opticap XL and XLT Disposable Capsule Filters with Viresolve NFR Membrane

Opticap XL and XLT Disposable Capsule Filters with Viresolve NFR Membrane

Description
Viresolve NFR filters with Retropore^® membrane quickly and efficiently remove retroviruses from recombinant protein solutions or human plasma sources. Viresolve NFR filters are ideal for polishing monoclonal antibodies, and provide an easy-to-implement technology that eliminates retrovirus contaminants in essential media and protein feed streams. When placed downstream of a bioreactor, Viresolve NFR filters minimize infection risk in products and processes caused by viruses common to mammalian cell expression systems.


Fast, Reliable Clearance
Cast from polyethersulfone, Retropore membrane exhibits a patented void-free pore structure characterized by superior clearance and high flow rates. Denser internally than on its surface, the asymmetrical matrix of the membrane effectively traps large viruses and efficiently passes smaller proteins.

By providing fast and highly reliable clearance, Viresolve NFR filters improve product safety and protect downstream processes.


High Yields and Product Quality
Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide > 98% protein product yields, while low extractables ensure product quality. Retropore membrane technology passes proteins up to 700 kDa and consistently clears retroviruses at > 6 LRV (Log Reduction Value).


Regulatory Compliance
All Viresolve NFR filters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO^® 9001 Quality Management System.
Viresolve NFR Opticap capsules are integrity tested during manufacturing and supported by a Validation Guide to assist in compliance with regulatory requirements. For traceability and easy identification, each filter is labeled with the product name and identifying characteristics. Every Viresolve NFR filter is shipped with a Certificate of Quality.

Millipore has submitted a Biological Master File to the FDA and will submit it to other worldwide regulatory agencies needed to support customer applications. Please contact Millipore to obtain a Letter of Authorization to reference in your application.


Virus Retention
Pleated filters have been extensively tested using the 78 nm diameter F6. This bacteriophage is readily grown to monodispersed, uniform size, high titer challenges. A consistent > 6.5 LRV has been observed over the range of feedstock and processing conditions


Multiple Formats Available
Viresolve NFR with Retropore membrane is available in three formats and multiple configurations that vary by filtration area and the type of inlet/outlet connection. Choose the format that’s right for your process requirements:
- OptiScale^®-25 disposable capsule filters
- Opticap XL and XLT disposable capsule filters
- Cartridge filters


Opticap XL and XLT Disposable Capsule Filters
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 Opticap XL 4 and 10 capsule filters with Viresolve NFR membrane and unique capsule design minimize hold-up volume and reduce production losses.

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


Specifications    (return to top)

Opticap XL 4 Opticap XL 10 Opticap XLT 10 Opticap XLT 20 Opticap XLT 30 Filtration Area, m2 0.093 0.43 0.43 0.854 1.281 Materials of Construction Filter media Polyethersulfone Supports Polypropylene Structural components Polypropylene Vent O-ring Silicone Vent/Drain 1/4 in. hose barb with double O-ring seal Maximum Inlet Pressure, bar (psid) 5.5 (80) @ 25 °C Maximum Differential Pressure, bar (psid) Forward - 5.5 (80); Reverse - 3.5 (50) Sterilization Water wet filter for 10 min @ 2 bar (30 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min Bacterial Endotoxins Aqueous extraction contains <0.5 EU/mL as determined by the LAL test Bacteriophage Retention ≥6 LRV for F6 (78 nm) at challenge of 107 pfu/cm2 Non-Fiber Releasing Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). 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. Integrity Test, Air Diffusion @ 23 °C   ≤10 mL/min @ 3.4 bar (50 psig) in water ≤10 mL/min @ 3.4 bar (50 psig) in water ≤20 mL/min @ 3.4 bar (50 psig) in water ≤30 mL/min @ 3.4 bar (50 psig) in water Wetting/Flushing Water for 10 min at 2 bar (30 psi) Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.