ZenPure

ZenPure

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ZenPureMicrofiltration:

1. Maximizing protein recovery. 2. Complete asepsis: eliminating hose barbs

and triclamps. 3. New optimal design filter for bulk

throughput

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ZenPure

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ZenPureZeroing in on Protein

RecoveryThe economic impact of maximizing recovery of very

high value therapeutic products from single use systems

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Outline

• The Problem: Liquid Holdup in Single Use Systems• Currently Available Solutions• ZenPure’s ZenCap® Zero• Case Studies of Economic Impact

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The Problem: Liquid Holdup

• Liquid Holdup can account for significant product loss in biopharmaceutical processes.

• Process equipment can be designed to reduce holdup, and use of a purge-gas blow-down can remove residual holdup in many components.

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• Even lab-scale experiments can result in significant liquid holdup if no measures are taken.

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The Problem: Holdup in Filter Capsules

• Void Spacesin the filtercapsule

• Downstreaminaccessibledue to filtermembrane

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The Problem: High Bubble Points• Microporous membrane filters resist the flow of gas

through their pores once wet-out with liquid.

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• Sterilizing-Grade Membrane filters have Bubble Points in the range of 50 psi.

• Many pre-filters have bubble points higher than 20 psi.• Air purge at these pressures is often not feasible in

single-use systems.

rKBP

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(where K is a constant based on properties of the

membrane and wetting fluid)

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Currently Available ‘Solutions’

• Ignore the problem– In many applications, the holdup is simply lost as reduced

yield.• Exceed Filter Bubble Point

– Typically not possible due to system pressure constraints.– May exceed Max Filter Differential Pressure for <0.2 µm

membranes.• Buffer Flush

– Benefits:• Removes all residual

– Disadvantages• Dilutes product (Costly to concentrate or unacceptable)• Cost of buffer

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ZenPure’s ZenCap® ZeroA patent pending technology, providing ready-to-use full size filter assemblies that have been specially designed for maximizing process efficiency.

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Optimized Capsule Design Reduces Void Space for Liquid Holdup

Sterile Air Port AllowsAccess to theDownstream Holdup

Multiple configurations andfittings types come standard

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Key Features

• ReducedVoid Space

• Sterile PortEliminatesDownstreamHoldup

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A ZenPure Patent Pending Technology

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Reducing Holdup to ZERO

• Compared with other commercially available capsule filters, the ZenCap Zero significantly reduces upstream and downstream holdup, effectively reducing it to ZERO.

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250-350 ml Saved per 10” Capsule

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Case Study

High Value Diagnostics• Cannot dilute final product using buffer flush.• 300 ml recovered fluid per run.• 250 filtration runs a year.• $100 value per ml. • Gives $7,500,000 valuable savings per year.

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Complete asepsis: eliminating hose barbs and triclamps.

New Filter Capsule Sanitary Connection.

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ZenPure

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Complete asepsis: eliminating hose barbs and triclamps.

1000’s of custom single use (SU) bag designs are used in our industry.

When over-molded sterile connections are the

preferred, the weakest link has been the hose barb to tube filter connection.

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ZERO ingress / ZERO egress filter capsules

New Sterile Connection• Seamless, gamma

stable TPE tube• Ready to over-mold • Soon: any length, any

diameter

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ZenPure

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Website: WWW.ZENPURE.COM Email: INFO-US@ZENPURE.COM

Mailing address:ZenPure Americas, Inc.

12030 Cadet CourtManassas, VA 20109

Phone: 703-335-9910Fax: 703-310-6232

Thank You!

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