Flexsafe® 3D Bag For Palletank®
Contents
1. 23 Flexsafe 3D System 100L 200L 500L Instructions for Use 11 Fig 25 12 3 4 Emptying Flexsafe 3D Bags 100L 200L and 500L Sartorius Stedim Biotech recommends dispensing through the bottom 1 Connect bottom tubing line to receiving system according to standard procedures for your site 2 Openany 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 position of the drain hole provide nearly 100 fluid recovery This efficiency can be improved by lifting the bag at the end of the operation see Fig 25 4 Once dispensing is completed clamp the line see Fig 17 and disconnect the Flexsafe 3D Bag from the receiving system 5 Unlatch and open the bottom gate see Fig 7 6 Lift the collapsed bag and remove it from the Palletank 7 Discard the Flexsafe 3D Bag in accordance with the procedures used on your site 4 Troubleshooting Guide The bag will not fill gt Check that any clamps on the filling line are open and that the tubing Is not pinched When filling through the bottom the bag comes out of the bottom gate gt The edge of the jaw is not closed inside the groove of the bottom port Position it correctly in the groove as described in step 10 of the2. Shipping Instructions for Use delivered with the Palletank Fig 6 Preparation of the Palletank 2 Before installing the Flexsafe 3D Bag in the Palletank check that the internal surfaces of the Palletank are dry smooth and free of any particles that might damage the bag surface 3 Open the bottom gate s see Fig 7 Check that the Palletank does not contain a filled Flexsafe 3D Bag failure to follow this instruction may result in product loss Unlatch the retaining clip from the fastening point on the jaw of the gate Grasp the mobile side of the gate and swing the bottom gate completely open 1 Swinging portion of bottom gate 2 Fixed portion of bottom gate 3 Retaining clip fastening point 4 Retaining clip Fig 7 Bottom gate closed Bottom gate opened Flexsafe 3D System 100L 200L 500L Instructions for Use 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 for all bags including the 100L CAUTION For all other Palletank types a 100L Flexsafe 3D Bag should be used with a 200L Palletank as they share the same footprint 2 Check that the irradiation indicator on the label is red to indicate irradiated product Record the batch number of the bag as seen on the product l
3. installation procedure The bag looks very full before reaching the nominal volume The bag is most likely inserted backwards into the Palletank If possible given the volume in the bag open the bottom gate spin the bag 180 around the bottom gate and close the bottom gate Examine Figures 15 amp 16 for proper bag positioning It is critical that the bottom seam of the bag be along the centerline of the Palletank for proper deployment The bottom of the bag is incorrectly positioned gt Place the corners of the bag in the corners of the Palletank make sure that only 10 of nominal capacity for 200L 500L and 20 of nominal capacity for 100L is filled before adjusting otherwise bag failure may occur Many folds appear in the bag during filling gt The bag is too big for the Palletank verify the bag size from the outer packaging and use the bag suitable for the size of the Palletank The bag does not reach the walls of the Palletank gt The bag is too small for the Palletank Verify the bag size from the outer packaging and use the bag suitable for the size of the Palletank The bag will not drain gt gt Check that any clamps on the drain line are open and that the tubing Is not pinched Flexsafe 3D System 100L 200L 500L Instructions for Use Troubleshooting Guide 5 Precautions for Use gt To ensure trouble free operation the Sartorius Stedim Biotech Flexsafe 3D Bag must be used with th
4. abel see Fig 8 3 Ona table position the bag so that both the bottom port and the 4 port system are facing you with the bottom port underneath This correct positioning will ensure a proper insertion of the Flexsafe 3D Bag in the Palletank 4 To open and remove the secondary external packaging see Fig 9 ear 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 Fig 9 7 Unfold the bag and remove any adhesive tape or protective foam from the Flexsafe 3D Bag see Fig 10 Fig 10 Flexsafe 3D System 100L 200L 500L Instructions for Use 7 8 US Fig 11 9 D D 10 Fig 14 Remove the reversible cable tie on the bottom line see Fig 11 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 Position yourself on the side of the Palletank closest to the bottom gate If you are using the Palletank for In Process Fluid Handling Insert the folded bag in the Palletank by the front opening in such a way that the bottom port is positioned towards the bottom gate If you are using
5. able of Contents 3 4 Flexsafe 3D Bag 100L 200L 500L For use with Palletank for Storage 200L amp 500L Palletank for Storage stackable 200L amp 500L Palletank for In Process Fluid Handling 200L amp 500L Palletank for Shipping 100L 200L amp 500L Plastic Palletank 200L amp 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 The Flexsafe 3D System is composed of a disposable sterile bag the Flexsafe 3D Bag and the Palletank rigid container constructed of stainless steel or plastic The Palletank 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 When filling the bottom and sides of the bag conform to the shape and dimensions of the Palletank The exact fit ensures bag functionality by eliminating folds or creases in the bag film The Flexsafe 3D System has been designed with a bottom port that allows bottom drainage of the bag for virtually 100 fluid recovery Typical applications for the Flexsafe 3D System include processing storage and transport of large volume biopharmaceutical s
6. any other Palletank insert the folded bag by the top of the Palletank in such a way that the bottom port is positioned towards the bottom gate Insertion of the bottom port tube in the bottom gate Carefully feed the bottom drain line through the Palletank bottom gate using two hands to ensure the line does not reach the floor Maneuver the bag bottom port so that the groove in the bottom port is inserted with the fixed portion of the bottom gate see Fig 13 While holding the bottom port firmly close the mobile jaw of the gate Ensure that the groove of the bottom port is captured by both halves of the gate to prevent movement of the bottom port during filling see Fig 14 Latch the bottom gate to secure the bottom port within the gate The port should be snug in the gate and not have room for movement Check that the bottom port is properly seated in the bottom gate by firmly but gently tugging on the bottom port and checking for movement If the bottom port appears to have freedom of movement repeat step 10 Unfold the bag and drape the 4 port system and the top tubing onto the Palletank front wall 8 Flexsafe 3D System 100L 200L 500L Instructions for Use 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 corr
7. e Sartorius Stedim Biotech Palletank gt The Palletank must be clean and dry before inserting the Flexsafe 3D Bag Traces of cleaning agents left on the Palletank can potentially damage the Flexsafe 3D Bag gt 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 gt Avoid the use of sharp objects scissors cutters scalpels etc in the vicinity of the Flexsafe 3D Bag gt The Flexsafe 3D Bag should never be handled or carried by its connections i e tubing gt Avoid folding the Flexsafe 3D Bag other than using the original folds provided gt When positioning the Flexsafe 3D Bag in the Palletank and during any adjustments after the initial fill handle the bag with care and use appropriate force Avoid pulling with your full strength If such strength is required it is likely inappropriate to adjust the bag at this time due to the fill volume gt The fFlexsafe 3D Bag is designed for single use and should not be re used 6 Flexsafe 3D Bag Storage Conditions Flexsafe 3D Bags should be stored in their original primary packaging at room temperature 5 C to 40 C in a dry environment Precautions for Use Flexsafe 3D Bag Storage Conditions 13 14 7 Shelf Life of a Flexsafe 3D Bag The sh
8. ectly positioned along the centerline of the Palletank and parallel to the front and back of the container see Fig 16 14 Remove the reversible cable tie s on the top lines see Fig 11 Fig 16 15 Position all clamps as close as possible to their bag ports remove their protection cap and close all of them see Fig 17 Fig 17 Flexsafe 3D System 100L 200L 500L Instructions for Use 9 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 If you are using the Palletank for In Process Fluid Handling and filling through the top be particularly careful not to connect any tubing through CAUTION the front doors 3 Open any clamps on the filling line see Fig 18 Fig 18 4 Start to fill the Flexsafe 3D Bag Sartorius Stedim Biotech recommends the use of peristaltic pumps for filling and dispensing from the bag see Fig 19 Fig 20 As the bag fills make sure the liquid not get entrapped into the bag fold Regularly lift the bag from the top to have the liquid falling at the bottom of CAUTION the Palletank see Fig 20 As the bag fills make sure that no tubing becomes trapped between the bag and the Palletank 10 Flexsafe 3D System 100L 200L 500L Instruc
9. elf 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 8 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 Shelf Life of a Flexsafe 3D Bag Product Complaint 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 respons
10. ibility for the use of Flexsafe 3D Bags with any containers other than Sartorius Stedim Biotech Palletank 3 Sartorius Stedim Biotech will not assume any responsibility if the Flexsafe 3D Bag instructions for use as described in this document are not strictly followed and the above mentioned Precautions for Use are ignored Upon request Sartorius Stedim Biotech Application Specialist can provide training to any interested end users 4 Sartorius Stedim Biotech will not be 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 10 Warranty Sartorius Stedim Biotech warrants that the Flexsafe 3D Bag is produced according to specifications Unless otherwise provided for in specifications that are individually agreed upon the general Sartorius Stedim Biotech specifications will apply In the case of a defective bag please follow the above mentioned Product Complaint Procedure 11 Trademark Flexsafe and Palletank are registered trademarks of Sartorius Stedim Biotech Disclaimers Warranty Trademark 15 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 wi
11. olutions under sterile conditions The extended standard product range with proven application specific designs in combination with the Palletank allow the Flexsafe 3D System to meet your needs for a wide range of bioprocessing applications Flexsafe 3D bags and corresponding Palletank for the are currently available from 100L to 1000L The System can be moved with a pallet jack forklift or a dolly up to 1000L Purpose his instruction for use describes the operations required to prepare fill and drain a 100L 200L or 500L Flexsafe 3D Bag in its dedicated Palletank Flexsafe 3D Bag 100L 200L 500L Introduction 2 Palletank amp 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 3 Palletank for In Process Fluid Handling Fig 4 Palletank for Shipping 2 2 Flexsafe 3D Bag Description see Fig 5 1 K seals 2 4 port system 3 Bottom port 4 Filling tubes Dispensing tubes 5 Filling tube Dispensing tube 6 Clamp Fig 5 Palletank amp Flexsafe Bag Description 5 3 Hexsafe 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
12. sartorius biotech User Manual Flexsafe 3D Bag For Palletank 100L 200L and 500L TAE MAI 85037 550 76 Vers 09 2015 IU114788 Table of Contents Flexsate 3D Bag 100L 200L 500 bi osc s scwcsoeinecuagscunahavanucnaseontenseadexa s 4 1 Introduction 0 0 0 cece enn cent net ne 4 2 Palletank amp Flexsafe Bag Description 0 ccc eee cece 5 21 P lletank Descrip UO cine indatecenec dune denti aser wed Unc EE NEE ATEN 5 2 2 Hexeate 3D Bag DeSChOtlON sis sm in etn safe a vinti an dai ties 5 3 Flexsafe 3D System 100L 200L 500L Instructions for Use 6 3 1 Preparation of the Palletalk osa eestavd rade bise errans d id reb S xdi 6 3 2 Hexsatre 3D Bag Installation TOOL 200L bOOL aue d usesn vescnnevedsvecs 7 3 3 Filling of 100L 200L and 500L Flexsafe 3D Bags ssssesueueuuuuue 10 3 4 Emptying Flexsafe 3D Bags 100L 200L and 500L susueuuue 12 4 Troubleshooting Guide Ltu iuuuiussssssssssesseessessee 12 5 Precautions for Use 0 0 0 eee eee e ne 13 6 Flexsafe 3D Bag Storage Conditions 0 0 0 cece eee 13 7 Shelf Life of a Flexsafe 3D Bag 0 0 c cece ence eens 14 8 Product Complaint 0 0 0 0 n rnrn 14 S MEMOIRE DTI TERT 15 10 Waranty 15 T1 Tradema k oe a tvece penance sapensewepeda essa advecenekaeeseped NEUE EAEE TENTE 15 T
13. thout 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 SPT6012 e150902
14. tions for Use 5 After 10 of the bag s nominal capacity for 200L and 500L or 20 of the bag STOP PUMP capacity for the 100L stop the filling and perform the following steps T see Fig 21 4 Remove the top port of the bag from the front side of the Palletank and allow Wd it to sit freely within the Palletank Manually adjust each bag corner to its appropriate position If you use the Palletank for In Process Fluid Handling close the hinged front doors and secure the four locking systems 2001 5001 100 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 eliminates risky bag manipulations post installation As the bag fills the Deploying Accessory removes all tension from the top of the bag by allowing the top tubing to gradually slide along the Accessory allowing for a reproducible and effortless bag deployment to its appropriate position within the Palletank for Storage and In Process Fluid Handling Please contact your sales representative for further details Fig 21 6 Fill the bag to its nominal capacity see Fig 22 and stop the filling Fig 22 7 Ifyou 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 23 8 Close the clamps see Fig 17 and disconnect the filling line Fig
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