Opticap XL and XLT Disposable Capsule Filters with Viresolve NFP Membrane

Opticap XL and XLT Disposable Capsule Filters with Viresolve NFP Membrane

Opticap XLT

Description
Viresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates. Viresolve NFP filters add speed and dependability to viral clearance in therapeutic drug manufacturing applications. Operated in normal flow filtration mode, these filters are ideal for monoclonal antibody polishing applications eliminating small virus contaminants from essential media and feed streams containing dilute peptides. When placed upstream of bioreactors, Viresolve NFP filters minimize infection risk caused by viruses common to mammalian cell expression systems.

For plugging streams Millipore recommends the Viresolve Prefilter for use with Viresolve NFP filters. This robust filter configuration improves NFP filter capacity significantly reducing your overall virus filtration costs.


Rapid, Reliable
Composed of a patented PVDF material, Viresolve NFP membranes possess a unique pore structure with characteristics that enhance filtration efficiency. Excellent flow-through qualities allow NFP membranes to provide highly efficient separations at flow rates 6 to 10 times faster than competitive products. Inherent sizeexclusion properties reliably retain specific-sized contaminants, improving product safety and protecting downstream processes.

The Viresolve Prefilter is available for use in series with Viresolve NFP filters. The prefilter effectively removes fouling material from biotech feeds and improves filtration economics by protecting the Viresolve NFP viral clearance filters.


Convenient and Easy to Use
Autoclavable, easily installed, and quickly integrity tested, single-use Viresolve NFP filters are designed to minimize the time and expense associated with assembling, cleaning and validation. Easy-turn valves for vent adjustments on our disposable capsules allow precise process control. O-ring seals, flow direction arrows, and the option for hose barb connections molded onto housings ensure a tight fit and proper orientation during installation.


Regulatory Compliance
All Viresolve NFP filters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO^® 9001 Quality Management System.
Viresolve NFP small area devices, capsules and cartridges 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 NFP 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.


Delivers High-Quality Filtered Protein
Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide >98% protein product yields. Low extractables ensure product quality.

Viresolve NFP size-exclusion membrane technology passes proteins up to 160 kDa in size and consistently clears parvovirus at >4 logs, without compromising flow rate.


Multiple Formats Available
Viresolve NFP membranes are offered in multiple device configurations that vary by filtration area and inlet/outlet connection type. Viresolve NFP filter units are available as OptiScale 25 mm devices, Opticap capsules, and cartridge filters that accommodate volumes ranging from 70 mL through thousands of liters at process scale.


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 10 capsule filters with Viresolve NFP 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 NFP 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 10 Opticap XLT 10 Opticap XLT 20 Opticap XLT 30 Filtration Area, m2 0.42 0.42 0.84 1.26 Materials of Construction Filter media Modified PVDF 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 5 min @ 3.4 bar (50 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 ≥4 LRV for FX-174 (28 nm) at a 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. TOC/Conductivity Lot release testing on effluent exhibited less than 500 ppb TOC and conductivity less than 1.3 µS/cm after autoclaving and a water flush of: 12 L at 25 °C 12 L at 25 °C 24 L at 25 °C 36 L at 25 °C Integrity Test, Air Diffusion @ 23 °C ≤10 mL/min @ 3.45 bar (50 psig) in water ≤10 mL/min @ 3.45 bar (50 psig) in water ≤20 mL/min @ 3.45 bar (50 psig) in water ≤30 mL/min @ 3.45 bar (50 psig) in water Wetting/Flushing Water for 5 min at 3.4 bar (50 psi) Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.