OptiScale‑25 Capsules with Viresolve NFR Membrane

OptiScale‑25 Capsules 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 Optiscale 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
OptiScale-25 disposable capsule 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


OptiScale-25 Small Volume Disposable Capsule Filters
OptiScale-25 capsules with Viresolve NFR membrane are used in small volume applications where feedstock requirements are minimal. Providing an active filtration area of 3.5 cm², these small devices are useful as an evaluation tool for impurity studies, protein passage studies, membrane area determination, and virus validation. A female Luer-Lok^™/male Luer slip connection ensures fast and secure setup.

OptiScale-25 disposable capsule filters are sold in Evaluation Kits that contain 9 devices, either 3 each from different membrane lots or all 9 from a single membrane lot. These are ideal for use in validation and sizing studies with Millipore’s Low Hold Up Volume Vmax^™ Test Kit.


Specifications    (return to top)

OptiScale-25 Materials of Construction Filter Polyethersulfone O-ring Silicone Capsule PVDF Effective Filtration Area, cm2 3.5 Maximum Differential Pressure, bar (psid) Forward - 4.1 (60) @ 25 °C; Reverse - 0.7 (10) @ 25 °C Bacteriophage Retention Lot release testing on samples exhibited > 6 LRV for F6 (78 nm) at a challenge of 107pfu/cm2 Bacterial Endotoxins <0.5 EU/mL as determined by the LAL test Sterilization Not autoclavable but are sold gamma irradiated 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. Non-Fiber Releasing Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. Wetting/Flushing Water wet filter for 10 minutes at 2 bar (30 psi)