SpectrumLabs Tangential Flow Depth Filtration Product Instructions For Use

Product Instructions for Use

Tangential Flow Depth Filtration

®

(TFDF®)

Introduction

SpectrumLabs.com offers a unique TFDF®filter that combines
the benefits of the non-fouling nature of tangential flow filters

ith the benefits of high dirt capacity depth filters. Please refer

w
to the following instructions for the care and use.

A. Materials of Construction

Housing: Polysulfone

Filter Media: HDPE 1-3um Pore Rating

HDPE 2-5um Pore Rating

Potting Material: Urethane

-All materials USP Class VI compatible

-Pore Ratings for reference only: Retention rating may vary
based on application

B. Filter Preparation

TFDF®filters are shipped ready-to-use with no surfactant or
storage agent. Filters wet readily with water and/or buffer.

C. Filter Sterilization

SpectrumLabs.com recommends using the filters with Pro­Connex
gle-use MagLev pump and pressure sensors for perfusion
applications. When needed, Sampler and MiniKros
ters part numbers beginning with S and N) filters can be auto­claved one time using the conditions below:

NOTE: KrosFlo

1. Remove and discard all pouches, as these are not auto-

2. Loosen all module connections to avoid damaging the

3. Wrap all open ports of the connecting tubing with auto-

®

Ready-to-Use, Sterile Flow Paths that include the sin-

®

filters (fil-

®

and KrosFlo®Max filters (filters beginning
with K or X) have not been validated for autoclave
cycles.

clavable; wet the membrane (optional).

module during the autoclave cycle.

clave paper, making sure permeate cavity is open to
steam penetration along with the inlet/retentate side.

4. Ramp up the autoclave by increasing the temperature by
1-2°C/min up to 121°C (15 psig)

TANGENTIAL FLOW DEPTH FILTRATION®(TFDF®) p 1

Tangential Flow Depth Filtration®(TFDF®)

. Hold the autoclave at or above 121°C for 50 min, not to

5

exceed 124.1°C.

6. Slowly ramp down the autoclave temperature by 1­2°C/min until room temperature.

. Filter Operation

E

SpectrumLabs.com recommends the following operating
parameters:

Pressure: Not to exceed 30psig inlet pressure.

7. Tighten all module connections.

8. Perform a module integrity test.

D. Integrity Test

Gross Leak Integrity Test

®

TFDF
extremely robust. When needed, an integrity test can be per­formed prior to use. The following pressure hold test is recom­mended to verify the integrity of a wetted filter.

1. With the bottom permeate port closed fully, wet the filter

2. Close retentate line and introduce air into the filter via the

3. Do not exceed 1.0 psi.

4. Wait. If rapid bubbles do not appear in the permeate cav-

filters are integrity tested prior to shipment and are

with water and ensure that permeate side outside of the
fibers is flooded. Direct the upper permeate line to drain.

inlet line with either pump or air source.

ity within 2-3 seconds, then module is integral. Small
bubbles will slowly start to form after a few seconds and
will increase in strength to rapid bubbles over time. The
first few seconds are key to see the gross failure.

NOTE:

Flow: For mammalian cell perfusion, shear rates from

As process pressures change, retention charac­teristics of the TFDF®filter might be affected.

1500s-1 to 3000s-1 are recommended. For protein
or virus clarification, shear rates of up to 8000s-1
may be required for better performance.

F. Storage

To optimize shelf life, we recommend store in original packag­ing at ambient conditions protected from moisture, extreme
temperatures, and UV light.

NOTE: The TFDF

tives are a high probability. If rapid bubbles are
seen in the first few seconds, redo wet-out proce­dure and integrity test to confirm gross integrity fail­ure.

®

media readily passes air so false nega-

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TANGENTIAL FLOW DEPTH FILTRATION®(TFDF®) p 2