Flexsafe® 3D Bag For Drum
Contents
1. Flexsafe 3D Bag for Drum can be stored in their original primary packaging at room temperature 5 C to 40 in a dry environment 9 Shelf Life of a Flexsafe 3D Bag for Drum The shelf life after gamma sterilization has been validated as indicated on the labelling product packaging and case and in the specifications Details are available from Sartorius Stedim Biotech upon request 12 Flexsafe 3D Bag for Drum Storage Conditions Shelf Life of a Flexsafe 3D Bag for Drum 10 Product Complaint When is a complaint justified When a deficiency related to the safety quality identity or purity or a deficiency in providing a service is identified on a marketed product To whom should the complaint be sent 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 the bag or bag system product part number and lot number the description of the issue the description of the process in which the issue was detected the amount of products affected samples or pictures if no samples are available If samples are returned they must be empty rinsed and decontaminated if applicable They must be returned with the signed the Health and Safety part of the complaint form 11 Disclaimers 1 Sartori2. the Flexsafe 3D Bag for Drum in the plastic drum check that the internal surfaces of the drum are smooth dry and free of any particles that might damage the bag surface 2 Obtain a packaged Flexsafe 3D Bag for Drum of the appropriate size according to your requirements Bag sizes match drum sizes as described in the plastic drum dimensions see 2 1 Plastic drums description and dimensions Record the batch number of the bag as seen on the product label Check that the irradiation indicator on the label is red see Fig 3 to indicate irradiated product 3 On a table position the bag so that both the bottom port and the 4 port system are facing you with the bottom port underneath if applicable and the 4 port system uppermost This correct positioning will ensure a proper insertion of the Flexsafe 3D Bag in the drum Fig 3 4 To open and remove the secondary external packaging see Fig 4 Tear open one of the corners and open completely by tearing along the weld Remove the secondary packaging by sliding it away from the Flexsafe 3D Bag 5 Check that the Flexsafe 3D Bag secondary packaging is free from any damage that could compromise the sterility 6 Repeat the 4 and 5 steps for the primary internal packaging 7 Unfold the bag and remove any adhesive tapes or protective foams from the Flexsafe 3D Bag see Fig 5 Fig 5 8 Remove the reversible cable tie on the bottom line
3. 8 2 Connect the bag to the supply line in accordance with the aseptic procedures used on your site 3 Open any clamps on the filling line from which the bag will be filled see Fig 10 Fig 10 4 Start to fill the Flexsafe 3D Bag Sartorius Stedim Biotech recommends the use of peristaltic pumps for filling and dispensing from the bag During filling with the first 10L of fluid ensure the bottom port remains in horizontal position CAUTION As the bag fills make sure the liquid does not get trapped into the bag fold Regularly lift the bag from the top to have the liquid falling at the bottom of the drum See Fig 11 8 Flexsafe 3D Bag Filling 5 After filling the bag to 10 of the bag s nominal capacity allowing the bottom of the bag to be completely opened out stop filling and perform the following steps see Fig 12 Remove the top port of the bag from the front of the drum and allow it to sit freely within the drum Slightly move the Flexsafe 3D Bag to center it in the container Fig 12 6 Hill the bag to its nominal capacity and stop the filling 7 If you have chosen to fill through the top empty the liquid contained in the filling line into the bag by raising the tube vertically over the bag see Fig 13 Fig 13 8 Close the clamps see Fig 9 and disconnect the filling line Flexsafe 3D Bag Filling 9 5 Emptying Flexsafe 3D Bags Dispensing of the bag can b
4. e done either from the top or the bottom lines 1 Connect the bottom tubing line to receiving system according to standard procedures for your site 2 Open any clamps on the draining line see Fig 10 Drain the bag gravity can be used using the bottom line if applicable but for faster draining and maximum product recovery Sartorius Stedim Biotech recommends the use of a peristaltic pump 3 The bag collapses as it is drained Lift the bag at the end of the draining to obtain nearly 100 fluid recovery see Fig 14 Fig 14 4 Once dispensing has been completed clamp the line see Fig 9 and disconnect the Flexsafe 3D Bag from the receiving system 5 Discard the Flexsafe 3D Bag in accordance to the procedures used on your site 10 Emptying Flexsafe 3D Bags 6 Troubleshooting Guide The bag will not fill gt gt Check that any clamps on the filling line are open and that the tubing is not pinched Many folds appear in the bag during filling gt The bag is too big for the drum Verify the bag size from the outer packaging and use the bag suitable for the size of the drum The bag does not reach the walls of the drum gt The bag Is too small for the drum Verify the bag size from the outer packaging and use the bag suitable for the size of the drum The bag will not drain gt gt Check that any clamps on the drain line are open and that the tubing is not pinched 7 Precautions of Use 1 To
5. ensure trouble free operation Sartorius Stedim Biotech Flexsafe 3D Bag for Drum must be used with a dedicated drum whose size must fit Bag sizes matches drum sizes as described in the container dimensions parts see 2 Plastic drum description and dimensions 2 The drum must be clean and dry before inserting the Flexsafe 3D Bag for Drum Refer to the drum cleaning instructions that are delivered with it Traces of cleaning agents left on the container can potentially damage the Flexsafe 3D Bag for Drum 3 It is under the user s responsibility to verify the compatibility of the Flexsafe 3D Bag for Drum materials with the solutions used in your process Sartorius Stedim Biotech can provide guidelines for chemical compatibility biocompatibility and extractables 4 Avoid the use of sharp objects scissors cutters scalpels etc in the vicinity of the Flexsafe 3D Bag 5 Avoid folding the Flexsafe 3D Bag for Drum other than the original folds 6 When positioning the Flexsafe 3D Bag for Drum in the drum and during any adjustment after the initial fill handle the bag with care and use appropriate force Avoid pulling with your full strength If such is required it is likely inappropriate to adjust the bag at this time due to the fill volume 7 The Flexsafe 3D Bag for Drum is for single use and should not be re used Troubleshooting Guide Precautions of Use 11 8 Flexsafe 3D Bag for Drum Storage Conditions
6. is publication may be reprinted or translated in any form or by any means without prior written permission from Sartorius All rights reserved by Sartorius in accordance with copyright law The information and figures contained in these instructions correspond to the version date specified below Sartorius reserves the right to make changes to the technology features specifications and design of the equipment without notice Last updated 09 2015 Sartorius Stedim Biotech GmbH Goettingen Germany Printed in the EU on paper bleached without chlorine W Publication No SPT6014 e150902
7. lly 100 fluid recovery The Drum supports the fluid contained within the Flexsafe 3D Bag The two make up the System and must be used together to ensure a robust process solution The System can be moved with a dolly up to 200L Purpose This instruction for use describes the operations required to prepare fill and drain a 50L 100L 200L Flexsafe 3D Bag for Drum in its dedicated plastic drum 2 Plastic Drum amp Flexsafe 3D Bag for Drum Description 2 1 Plastic Drum description and dimensions Sartorius Stedim Biotech currently offers a range of plastic drums see Fig 1 available in 3 sizes 50L 100L and 200L for use with Flexsafe 3D Bags for Drum of the same volume 2 sartorius stedim Fig 1 Plastic drum dimensions approx for Flexsafe 3D Bag for Drum Nominal Part Description Drum internal Drum internal volume number diameter height in litres inmm inches in mm inches Approx Approx 50L FBC125627 STD DRUM BTM DR 50L 346 13 5 8 702 27 5 8 100L FBC125628 STD DRUM BTM DR 100L 467 18 3 8 759 29 7 8 200L FBC125629 STD DRUM BTM DR 200L 559 21 1 2 918 36 11 16 2 2 Flexsafe 3D Bag for Drum description see Fig 2 1 K seals 2 4 port system 3 Bottom port if applicable 4 Filling tubes Dispensing tubes 5 Dispensing tube if applicable Plastic Drum amp Flexsafe 3D Bag for Drum Description 5 3 Flexsafe 3D Bag for Drum Installation into the Drum 1 Before installing
8. nii Sartorius biotech User Manual Flexsafe 3D Bag For Drum 50L 100L 200L ei A m i AA oe E E ae ei DIDIER 85037 550 78 Vers 06 2015 IU114787 Table of Contents Te d es ro 4 2 Plastic Drum amp Flexsafe 3D Bag for Drum Description 5 2 1 Plastic Drum description and dimensions 2 22 rer 5 2 2 Flexsafe 3D Bag for Drum description 5 3 Flexsafe 3D Bag for Drum Installation into the Drum 6 4 Flexsafe 3D Bag Fillin s sde ube Ee estate 8 5 Emptying Flexsafe 3D Bags 10 6 Troubleshooting Guide 11 7 Precautions of TEE 11 8 Flexsafe 3D Bag for Drum Storage Conditions 12 9 Shelf Life of a Flexsafe 3D Bag for Drum 12 10 Product Complaint 13 Lt DS COR EE EE EE E 13 KW ET EE 14 13 eelere a en E 14 Table of Contents 3 A Introduction 1 Introduction Flexsafe 3D Bags for Drum are designed for processing and storage of large volume biopharmaceutical solutions in drum containers The Flexsafe 3D Bag for Drum are available in 50L 100L 200L to fit plastic drums They are available in standard either with top lines or with top and bottom lines for virtua
9. see Fig 6 Fig 6 6 Flexsafe 3D Bag for Drum Installation into the Drum 9 To position the bag inside the drum see Fig 7 Hold the folded bag on both arms with the 4 port system uppermost facing the user and the single bottom port underneath if applicable Position yourself on the side of the drum closest to the bottom hole of the drum Fig 7 10 Install the Flexsafe 3D Bag in the drum See Fig 8 gt If you are using a Flexsafe 3D Bag with the bottom port Position the bag in such a way that the bottom port tube is positioned towards the drum bottom hole Carefully feed the bottom drain line through the drum bottom hole and take it out The bottom port must be positioned in horizontal position Unfold the bag and drape the 4 port system and the tubing onto the wall of the drum gt If you are using a Flexsafe 3D Bag without the bottom port Position the bag inside the drum Unfold the bag and drape the 4 port system and the tubing onto the front wall 11 Remove the reversible cable tie s on the top lines see Fig 6 Fig 8 12 Position all clamps as close as possible to their bag ports remove their protection cap and close all of them see Fig 9 Fig 9 Flexsafe 3D Bag for Drum Installation into the Drum 7 4 Flexsafe 3D Bag Filling Sartorius Stedim Biotech recommends the filling through the top port of the bag 1 Check that all clamps are closed see Fig
10. us Stedim Biotech Flexsafe 3D Bag is for single use only Sartorius Stedim Biotech will not endorse any responsibility for re use of the Flexsafe 3D Bag 2 Sartorius Stedim Biotech will not endorse any responsibility if the Drum instructions for use and the Flexsafe 3D Bag instructions for use as described in this document are not strictly followed and the above mentioned Precautions of Use applied Upon request Sartorius Stedim Biotech Application Specialists can perform training to any interested end users 3 Sartorius Stedim Biotech is not responsible for any special incidental or consequential damages resulting from any legal theory including lost profits downtime goodwill damage to or replacement of equipment or property Product Complaint Disclaimers 13 14 Warranty Trademark 12 Warranty Sartorius Stedim Biotech warrants that the Flexsafe 3D Bag for Drum is produced according to specifications Unless otherwise provided for in agreed upon Specifications the general Sartorius Stedim Biotech specifications will apply In the case of a defective bag please follow the above mentioned product complaint procedure 13 Trademark Flexsafe is registered trademark of Sartorius Stedim Biotech 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 th
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