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Summary of Contents for Sartorius Stedim Biotech Flexsafe 3D Bag 100L
- Page 1 User Manual Flexsafe 3D Bag For Palletank ® ® 100L, 200L and 500L 85037-550-76 Vers. 09 | 2015 IU114788...
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Page 3: Table Of Contents
Table of Contents Flexsafe 3D Bag 100L, 200L, 500L ® ........... Introduction . -
Page 4: Flexsafe ® 3D Bag 100L, 200L, 500L
® 1. Introduction Flexsafe 3D standard bags are designed for processing, storage and transport of ® large volume biopharmaceutical solutions in Sartorius Stedim Biotech’s Palletank ® containers. Flexsafe meets your requirements for outstanding robustness and ® ease of use for all your single-use bioprocessing needs, from cell cultivation to shipping of drug substance. -
Page 5: Palletank ® & Flexsafe ® Bag Description
2. Palletank & Flexsafe Bag Description ® ® 2.1 Palletank Description ® Sartorius Stedim Biotech currently offers 5 ranges of Palletank for use with ® 100L, 200L and 500L Flexsafe 3D Bags. ® Fig. 1: Palletank ® for Storage Fig. 2: Plastic Palletank ®... -
Page 6: Flexsafe ® 3D System 100L, 200L, 500L Instructions For Use
3. Flexsafe 3D System 100L, 200L, 500L ® Instructions for Use 3.1 Preparation of the Palletank ® 1. If you use: the Palletank for In-process Fluid Handling, open the hinged front doors by ® removing the four locking systems (see Fig. 6) the Palletank for Shipping, please refer to the Palletank for Shipping... -
Page 7: Flexsafe 3D Bag Installation, 100L, 200L, 500L
3.2 Flexsafe 3D Bag Installation, 100L, 200L, 500L ® 1. Obtain a packaged Flexsafe 3D Bag of the appropriate size and position it on a ® smooth table with no sharp angular corners. – If you are using a Palletank for Shipping, the bag size matches Palletank size ®... - Page 8 8. Remove the reversible cable tie on the bottom line (see Fig. 11). Fig. 11 9. To position the bag inside the Palletank ® (see Fig. 12): − Hold the folded bag on both arms with the 4-port system uppermost, facing the user and the single (bottom) port underneath −...
- Page 9 12. Ensure that the corners of the bag are in contact with the front corners of the Palletank ® so that the bag will take the shape of the Palletank ® . (see Fig. 15). Fig. 15 13. Check that the K-seal of the Flexsafe 3D bag is correctly positioned along the ®...
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Page 10: Filling Of 100L, 200L And 500L Flexsafe
3.3 Filling of 100L, 200L and 500L Flexsafe 3D Bags ® Sartorius Stedim Biotech recommends filling through the top ports of bags. 1. Check that all clamps are closed (see Fig. 17). 2. Connect the bag to the supply line in accordance with the aseptic procedures used on your site. - Page 11 In-Process Fluid Handling, close the hinged front ® doors and secure the four locking systems. Sartorius Stedim Biotech recommends the use of the Self Deploying accessory which eases the installation and the filling of the Flexsafe bag, saves operator time and ®...
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Page 12: Emptying Flexsafe 3D Bags 100L, 200L And 500L
2. Open any clamps on the draining line (see Fig. 18). Drain the bag – gravity can be used, but for faster draining and maximum product recovery, Sartorius Stedim Biotech recommends the use of a peristaltic pump (see Fig. 24). 3. The bag collapses as it is drained. The sloped bottom of the Palletank and the ®... -
Page 13: Precautions For Use
It is the user’s responsibility to verify the compatibility of the Flexsafe 3D Bag ® materials with the solutions used in his | her process. Sartorius Stedim Biotech can provide guidelines for chemical compatibility, biocompatibility and extractables. Avoid the use of sharp objects (scissors, cutters, scalpels, etc.) in the vicinity of the Flexsafe 3D Bag. -
Page 14: Shelf Life Of A Flexsafe 3D Bag
To your Sartorius Stedim Biotech commercial contact or distributor. How and which information should be conveyed? A complaint form will be provided by your Sartorius Stedim Biotech commercial contact and should be returned by e-mail, fax or letter with the following information: −... -
Page 15: Disclaimers
9. Disclaimers 1. Sartorius Stedim Biotech Flexsafe 3D Bag is for single-use only. ® Sartorius Stedim Biotech will not assume any responsibility of any kind if the Flexsafe 3D Bag has been re-used. ® 2. Sartorius Stedim Biotech will accept no responsibility for the use of Flexsafe ®... - Page 16 Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, Germany Tel.: +49.551.308.0 Fax: +49.551.308.3289 www.sartorius-stedim.com Copyright by Sartorius, Goettingen, Germany. No part of this publication may be reprinted or translated in any form or by any means without prior written permission from Sartorius.
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