Sartorius Sartoclear 29XDL10-FCFFF Manual

Directions for Use
Sartoclear®Depth Filter 0.08 m² Midscale Cassette
1. Introduction
The purpose of this document is to outline the
appropriate method for installing and using the
laboratory scale device of Sartoclear®Depth Filter
0.08 m² midscale cassette.
2. Liability
The products described in this document are intended
to be used for the clarification of mammalian and
microbial cell cultures. Sartorius shall not assume any
liability if Sartoclear®Depth Filter products have been
subjected to improper use.The use of this product for
any other applications or in another manner than
described in this manual may result personal injury or
malfunction of the product. Please follow the
instructions in this user manual to ensure your own
safety and to obtain optimal filtration results. In the
interest of product development, we reserve the right
to make changes.
3. Identification
This document pertains to Sartorius Stedim Biotech
Sartoclear®Depth Filter 0.08 m² cassette with the
following part numbers:
-
29XDL10-FCFFF
-
29XDL20-FCFFF
-
29XDL60-FCFFF
-
29XDL75-FCFFF
-
29XDL90-FCFFF
Connector types:
-
FF – ¾” Sanitary Flange
4. Wetting of a Sartoclear®Depth Filter 0.08 m²
midscale cassette
Sartoclear®Depth Filter 0.08 m² midscale cassette
must be flushed withWFI in order to remove air and
water soluble compounds originating from the raw
materials. For detailed extractable profiles please refer
to the validation guide: DIR code: 2632689
Fill the cassette withWFI with both vent valves on side
left open. Close both vent valves as soon as fluid flows
through the vent valves and start the flushing process.
Flushing volumes
In order to remove all air from the cassette it is
recommended to flush the cassette with at least
50 L/m² WFI (4 Liter per cassette).
Flushing rates
In order to remove all air from the cassette it is
recommended to use flow rates of max. 150 l/m²/h.
The flow rate during flushing should be 25% faster
than the flowrate used for filtration.
Prior filtration the remaining flushing liquid inside the
filter can be removed by using 0.4 bar pressurized air
to avoid dilution of the filtrate (see also Recovery
Optimization). Once Sartoclear®Depth Filter 0.08 m²
midscale cassette are completely drained, both drain-
age valves should be closed.The cassette is now ready
for the filtration process. It is recommended to vent
again before filtration.
5. Filtration
-
Start the Sartoclear®Depth Filter 0.08 m² midscale
cassette filtration with a flow rate between
80 – 200 L/ m2/h. (For most applications lower flow
rates give better throughputs per m²)
-
Close the vents on the IN- and OUTLETwhen the
housings are filled (fluid will appear in the tube)
-
Continue filtration until a pressure of maximal 1.5 bar
(21.75 psi) is reached.
-
NOTE: For an optimal recovery of your product it
is recommended to stop the filtration at 1.0 bar
(14.5 PSI) (see also: Recovery optimization)
-
The maximum operating pressure during filtration is
1.7 bar (24.7 psi)
-
The temperature of the fluid must be between
5 – 40° C
Mixing Peristaltic
pump Sartoclear
module Weight
control
Pressure
control
6. Recovery optimization
-
Connect a containerwith a suitable buffer foryour
application to the filtration set up
-
Start flushing the system with constant flow or
constant pressure
-
Best results were obtained with 20 L per m² depth
filter and a maximum pressure of 1.0 bar (14.5 psi)
-
Alternative Option: In order to avoid product dilution
pressurized air (max. 0.4 bar) can be used to empty
the filters (see below: B1 Draining of the system)

Draining of the system
B1
B2
Follow the steps A and B as shown in the schematic
overview above.
A) Close all openings (DRAIN, VENT and OUTLET) on
the OUTLET and the DRAIN on the INLET.
Open the vent on the INLET and pump in reverse
direction to remove the remaining fluid.
B1) Removal of fluid to the filtrate vessel (for recovery
optimization).
-
Close the INLET and open the OUTLET. Keep both
drains closed and use the VENT on the INLET to
apply pressurized air on the system.
-
Serial connected filtration steps (e.g. two different
depth filter grades) can be drained at once.The
VENTS and DRAINS of the secondary filtration step
should be closed.
B2) Removal of fluid to the Drain ports (to remove WFI
prior Depth Filtration).
-
Close the INLET and OUTLET. Connect the tubing
on the Drain ports to an appropriate container and
open the Drain ports. Pressurized air (max 0.4 bar or
5.8 psi) on the VENT of the INLET can be used to
enhance the draining process.
7. Disposal
All components of the Sartoclear®Depth Filter 0.08 m²
midscale cassette are non-hazardous and can be
disposed through normal waste removal methods, in
accordance with the local legislation. The disposal
method of the product may depend on the nature of
the residual material originating from the filtered
material.
8. Applications Support
Contact your local Sartorius Stedim Biotech represen-
tative to obtain general information and technical data.
We will be more than happy to assist your filtration trial
with one of our application specialists around the
globe.
9. Return of used Filter Elements
All used filter elements should be properly sterilized
prior to shipping to Sartorius Stedim Biotech. This
allows our staff to handle them with minimal risk during
the inspection of the filter elements. The German Law
requires that a return shipment form (available through
your local Sartorius Stedim Biotech representative)
must be completed prior to shipping of used filter
materials.
Thankyou for working with Sartorius Stedim Biotech,
we appreciate your business.
Specifications subject to change without notice.
Copyright Sartorius Stedim Biotech GmbH.
DIR: 2632377-000-00
Status: 08 | 2020
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
37079 Goettingen
Phone [phone]
www.sartorius.com
Sartorius Stedim NorthAmerica Inc.
5 Orville Drive
Bohemia, NY 11716
Toll-Free [phone]
Fax [phone]
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