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 Φ6. 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, Opticap XL and XLT Disposable Capsule Filters

Opticap 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.

Opticap Disposable Capsule Filters The capsule’s unique construction and pleated membrane minimize hold-up volume and reduce production loss. Opticap housings feature a patented design that withstands high thermal and hydraulic stress, assuring sterilization compatibility and the cleanest process possible.

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

	4-inch Opticap	10-inch Opticap	Opticap XL 10	Opticap XLT 10	Opticap XLT 20	Opticap XLT 30
Filtration Area, m²	0.09	0.43	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) @ 23 °C
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80). Reverse: 3.4 (50)
Wetting/Flushing	Water wet filter for 10 min at 2 bar (30 psi) or for 5 min at 3.4 bar (50 psi) to a volume of 75 L/m².
Sterilization	After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C, using liquid cycle, slow exhaust.
Gravimetric extractables	The extractables level was equal to or less than 7 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 35 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 35 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 35 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 70 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 105 mg after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature.
Bacterial Endotoxins	Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacteriophage Retention
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
Non-volatile Residue (NVR)	Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 800 mL	Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 4 L	Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 4 L	Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 4 L	Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 8 L	Meet the requirements of the USP Oxidizable Substances Test after a water flush of: 12 L
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	≤5 mL/min @ 3.45 bar (50 psig) in water	≤16 mL/min @ 3.45 bar (50 psig) in water	≤16 mL/min @ 3.45 bar (50 psig) in water	≤16 mL/min @ 3.45 bar (50 psig) in water	≤32 mL/min @ 3.45 bar (50 psig) in water	≤48 mL/min @ 3.45 bar (50 psig) in water
Thermal and Hydraulic Stress	Lot release testing on autoclaved samples at 25 ° C exhibited integrity after a forward stress to 5.5 bar (80 psid) and a reverse stress to 3.4 bar (50 psid).
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.

Select up to 5 products to compare them side by side

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Compare	Catalogue No.	Product Name	Process Volume, L	Connections, Inlet/Outlet	Qty/Pk
	KZRVA10TT1	Opticap XL 10 Capsule Filter	600–1200	38 mm (1-1/2 in.) Sanitary Flange	1
	KZRVA1TTT1	Opticap XLT 10 Capsule Filter	600–1200	38 mm (1-1/2 in.) Sanitary Flange	1
	KZRVA2TTT1	Opticap XLT 20 Capsule Filter	1200–2400	38 mm (1-1/2 in.) Sanitary Flange	1
	KZRVA3TTT1	Opticap XLT 30 Capsule Filter	1800–3600	38 mm (1-1/2 in.) Sanitary Flange	1
	XLTSTAND1	Opticap Stand			1

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