SpectrumLabs Tangential Flow Depth Filtration User manual

TANGENTIAL FLOW DEPTH FILTRATION®(TFDF®) p 1
Pr duct Instructi ns f r Use
Tangential Fl w Depth Filtrati n®
(TFDF®)
Intr ducti n
SpectrumLabs.com offers a unique TFDF®filter that combines
the benefits of the non-foulin nature of tan ential flow filters
with the benefits of hi h dirt capacity depth filters. Please refer
to the followin instructions for the care and use.
A. Materials f C nstructi n
Housin : Polysulfone
Filter Media: HDPE 1-3um Pore Ratin
HDPE 2-5um Pore Ratin
Pottin Material: Urethane
-All materials USP Class VI compatible
-Pore Ratings for reference only: Retention rating may vary
based on application
B. Filter Preparati n
TFDF ®filters are shipped ready-to-use with no surfactant or
stora e a ent. Filters wet readily with water and/or buffer.
C. Filter Sterilizati n
SpectrumLabs.com recommends usin the filters with Pro-
Connex®Ready-to-Use, Sterile Flow Paths that include the sin-
le-use Ma Lev pump and pressure sensors for perfusion
applications. When needed, Sampler and MiniKros ®filters (fil-
ters part numbers be innin with S and N) filters can be auto-
claved one time usin the conditions below:
NOTE: KrosFlo®and KrosFlo®Max filters (filters beginning
with K or X have not been validated for autoclave
cycles.
1. Remove and discard all pouches, as these are not auto-
clavable; wet the membrane (optional).
2. Loosen all module connections to avoid dama in the
module durin the autoclave cycle.
3. Wrap all open ports of the connectin tubin with auto-
clave paper, makin sure permeate cavity is open to
steam penetration alon with the inlet/retentate side.
4. Ramp up the autoclave by increasin the temperature by
1-2°C/min up to 121°C (15 psi )

5. Hold the autoclave at or above 121°C for 50 min, not to
exceed 124.1°C.
6. Slowly ramp down the autoclave temperature by 1-
2°C/min until room temperature.
7. Ti hten all module connections.
8. Perform a module inte rity test.
D. Integrity Test
Gross Leak Inte rity Test
TFDF ®filters are inte rity tested prior to shipment and are
extremely robust. When needed, an inte rity test can be per-
formed prior to use. The followin pressure hold test is recom-
mended to verify the inte rity of a wetted filter.
1. With the bottom permeate port closed fully, wet the filter
with water and ensure that permeate side outside of the
fibers is flooded. Direct the upper permeate line to drain.
2. Close retentate line and introduce air into the filter via the
inlet line with either pump or air source.
3. Do not exceed 1.0 psi.
4. Wait. If rapid bubbles do not appear in the permeate cav-
ity within 2-3 seconds, then module is inte ral. Small
bubbles will slowly start to form after a few seconds and
will increase in stren th to rapid bubbles over time. The
first few seconds are key to see the ross failure.
NOTE: The TFDF®media readily passes air so false nega-
tives are a high probability. If rapid bubbles are
seen in the first few seconds, redo wet-out proce-
dure and integrity test to confirm gross integrity fail-
ure.
TANGENTIAL FLOW DEPTH FILTRATION®(TFDF®) p 2
400-13770-000 Rev. 01 DCO 6536 • 170108
E. Filter Operati n
SpectrumLabs.com recommends the followin operatin
parameters:
Pressure: Not to exceed 30psi inlet pressure.
NOTE: As process pressures change, retention charac-
teristics of the TFDF ®filter might be affected.
Flow: For mammalian cell perfusion, shear rates from
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. St rage
To optimize shelf life, we recommend store in ori inal packa -
in at ambient conditions protected from moisture, extreme
temperatures, and UV li ht.
Tangential Fl w Depth Filtrati n®(TFDF®)
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