Opticap Disposable Capsule Filters with Viresolve Prefilter

Opticap Disposable Capsule Filters with Viresolve Prefilter

Description
The Viresolve Prefilter will improve the filtration economics of the viral clearance step by providing protection for Viresolve NFP viral clearance filters. Use of this prefilter with NFP will improve capacity and increase the life of the NFP filter. Available in scalable filter formats, this prefilter will easily fit in existing development and manufacturing processes.


Enhanced Viral Clearance
Viresolve NFP filters clear parvovirus from recombinant feed streams without compromising flow rates, adding speed and dependability to viral clearance in therapeutic drug manufacturing applications. These reliable filters are ideal for monoclonal antibody polishing applications eliminating small virus contaminants.

- Improves NFP capacity reducing overall filtration costs
- Maintain high product yields
- Simple, predictable scale-up and scale-down


Increased Capacity and Filter Life
Utilizing this prefilter in series with Viresolve NFP filters (NFP) will allow you to take advantage of NFP’s high flow rates and product yield. The prefilter effectively removes fouling components of the feed, leading to dramatic increases in the performance of the Viresolve NFP filter. This improved capacity significantly reduces the cost of the viral clearance step.


Regulatory Compliance
Viresolve Prefilters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO^® 9001 Quality Management System.
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 filter is shipped with a Certificate of Quality.


Multiple Formats Available
Viresolve Prefilters are offered in multiple device configurations.
- OptiScale^™-40 small scale disposable capsule filters
- Opticap^™ disposable capsule filters
- Pod disposable devices


Opticap Disposable Capsule Filters
Opticap disposable capsule filters feature a patented design that withstands high thermal and hydraulic stress, assuring sterilization compatibility.


Specifications    (return to top)

Filtration Area, cm2 850 Materials of Construction Media Inorganic filter aid w/cellulose & amide binders Structural components Polypropylene Supports Polypropylene Vent caps Polypropylene Housing Vent 1/8 in. Hose Barb Maximum Inlet Pressure, bar (psi) 5.5 (80) @ 25 °C Maximum Differential Pressure, bar (psi) Forward - 2.1 (30); Reverse - 2.1 (30) Sterilization 3 autoclave cycles of 60 min @ 123 °C TOC/Conductivity Lot release testing on effluent exhibited TOC <3 ppm and conductivity <10 µS/cm after autoclaving and a water flush of 10 L/0.1 m2 Metals Lot release testing on effluent exhibited the following values: Pb <0.01 mg/0.1 m2 Hg <0.01 mg/0.1 m2 As <0.01 mg/0.1 m2 Fe <0.1 mg/0.1 m2 Al <0.5 mg/0.1 m2 Bacterial Endotoxin Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. Component Material 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. Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. Quality Standard These products are manufactured in accordance with a Quality Management System that is approved by an accredited registering body to the appropriate ISO® 9000 Quality Systems Standard