Sartorius Sartoclear Caps Instructions For Use

Instructions for Use
Sartoclear Caps
®
1. Liability
Sartolear caps are non-certified filtration units for
®
small scale screening tests and not intended to be
used for clinical purposes.
The products described in this document are intended
to be used for the filtration of fluids of biological origin,
e.g. mammalian and microbial cell cultures and plasma
fractions. The use of this product for other applications
or in another manner as described in this manual may
result in personal injury or malfunction of the products.
Sartorius Stedim Biotech cannot assume liability if
Sartoclear products are subjected to improper use.
®
Please follow the user manual for your own safety and
to obtain optimal filtration results.
In the interest of product development we reserve the
right to make changes.
2. Identification
This document pertains to Sartorius Stedim Biotech
Sartoclear Caps with the following part numbers:
®
Multi Layer
29CDL10-CACHH--M
29CDL20-CACHH--M
29CDL60-CACHH--M
29CDL75-CACHH--M
29CDL90-CACHH--M
3. Connections
The in and outlet of the Sartoclear
barbs. For tubing with an inner diameter of 8" (3.2 mm)
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the male Luer adapter can be used.
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Installation of the male Luer adapter:
Connect the male Luer adapter to the tubing
Press the male Luer adapter in the Inlet of the filter
and turn it a until it is fixed (the male Luer adapter
exactly fits and will resist a pressure of 3 bar | 43.5 psi).
4. Sterilization | Autoclaving
Sartoclear Caps may be wet or dry sterilized by
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autoclave for 30 minutes at 121°C, at 1 bar. During
autoclaving the vent valve should be opened and
wrapped with autoclave paper. After the autoclave
cycle, please remove the capsule from the autoclave
and allow cooling down.
5. Rinsing
Sartoclear P filtration products must be rinsed prior
®
-
usage.
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Specifications:
Minimum volume: 50 L/m
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(For more details see also for validation guide)
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Recommend flowrate: 1.25 times the flowrate
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of filtration
Open the vent port and start rinsing.
Close the vent valve once liquid appears.
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Continue flushing the Sartoclear
so that entrapped air inside the media can be
released.
After flushing, fluid can be drained with pressurized
air or nitrogen at a maximum pressure of 0.5 bar | 7 psi.
Caps are hose
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(125 ml per Cap).
2
Cap upside down
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6. Filtration
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A constant flow rate is the most optimal filtration mode.
The recommended flow rates for Sartoclear
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Cell clarification application
(Post bioreactor & post centrifuge)
Max. 4 – 6 ml/min
Clarification application of Blood & Plasma derivates
Max. 2 – 3 ml/min
7. Pressure
Maximum allowable system pressure is 3 bar (43.5 psi)
at 20°C.
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Maximum allowable differential pressure in the
direction of filtration:
2 bar | 29 psi at 20°C
0.2 bar | 2.9 psi at 121°C
8. Disposal
All components of the Sartoclear
hazardous and can be disposed through normal waste
removal methods, in accordance with the local legisla-
tion. The disposal method of the Sartoclear
may depend on the nature of the residual material
originating from the filtered material.
9. 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.
10. Return of used filtration components
All used filters 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 filters. The 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.
Thank you for working with Sartorius Stedim Biotech,
we appreciate your business.
85037-551-54
P Caps:
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caps are non-
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products
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