Sartorius stedim BioWelder Operation Manual Download Page 4

 

4

    

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interchangable tube holders 
 
 

 

 
 

    

3.

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3.    

Function

Function

Function

Function

    

The BioWelder® is used to connect two pieces of thermoplastic tubing together 
under sterile conditions. Each piece of tubing is connected on one end to a 
container, bag, or process equipment. The other end is sealed by a clamp, plug,  
or other closure. 
 
To make a sterile connection, first insert both hoses which have to be welded 
together in the left and right tube holder of the BioWelder® in the correct position. 
Insert then a new cutting blade into the blade holder in the unit.  
 
The dosing of the cover initiates the steps in the welding program. In the first step, 
the cutting blade is heated up to more than 400°C and held there for 5 seconds. 
This step ensures that the blade is sterile and depyrogenated. Next, the blade is 
allowed to cool to a preset welding temperature depending on the type of tubing 
to be connected. The heated blade is then moved so that it melts through the two 
tubing pieces simultaneously. During this operation the blade temperature is 
controlled and the tubing is forced against both sides of the blade so that the 
operation remains sterile. Once the tubing has been cut, the machine slides the  
cut tubing pieces into alignment. The blade is then extracted while the tubing is 
pushed together. The tubing pieces remain at all times in contact with the hot 
blade ensuring sterile operation. Once the blade is fully extracted, the weld is 
allowed to cool. The release of the cover indicates the end of the welding and the 
machine can be opened.  
The connected tubing can then be removed, and is ready for use. The used blade 
and cut tubing ends are discarded.  
 
The BioWelder® is a fully automated device, and will only indicate the successful 
completion of the welding cycle if all operations have functioned properly.  
The procedure is completely reproducible and independent of operator skill.  
Therefore it can be readily validated to assure a sterile connection. Use of a new  
disposable blade for each cycle eliminates any potential cross-contamination  
concerns. 
 
The BioWelder® starts an initialization after every 9 welding cycles as soon as the 
cover will be closed. 
 
To simplify the documentation of the welding parameters the BioWelder® is 
equiped with, a printer interface with which the welding date can be protocolled 
after each welding. 
 
To simplify the validation and|or to allow the validation to the client, an optional 
adapted calibration set can be obtained. 

    

Summary of Contents for BioWelder

Page 1: ...Operation Manual Operation Manual Operation Manual Operation Manual BioWelder 85030 531 87...

Page 2: ...dix 4 Short form of the manual for the calibration holder 21 1 1 1 1 Manual Manual Manual Manual Please read this manual carefully It includes important information for the safe and successful use of...

Page 3: ...e of the equipment should not be done by children without adult supervision The blade reaches over 400 C during the welding cycle To avoid possible C burns DO NOT open the access door unless it is rel...

Page 4: ...mains sterile Once the tubing has been cut the machine slides the cut tubing pieces into alignment The blade is then extracted while the tubing is pushed together The tubing pieces remain at all times...

Page 5: ...blade Step 2 Blade heats up sterilization and then cuts through both tubing pieces Step 3 Tubing holders slide the cut tubing into alignment Hot blade is held against the cut tubing to ensure sterilit...

Page 6: ...upper and lower tubes are sealed on both sides Step 2 Blade heats up sterilization and then cuts through four tubing pieces Step 3 Tubing holders slide the cut tubing into alignment Hot blade is held...

Page 7: ...anguage Choose the language Choose the language Choose the language You can choose the language of your unit German or English To open this menu press MODE and the right arrow Enter the password 264 U...

Page 8: ...s you want to connect with a suitable disinfectant Place the hoses carefully in the tube holders The hose ends have to extend beyond the tube holders Attention Attention Attention Attention Check that...

Page 9: ...old the middle of the blade between two fingers Insert the blade into the blade holder and check that the blade locks in correct position and the point shown in the left picture shows to the temperatu...

Page 10: ...s The tubing holders can be quickly changed to connect different diameter tubing The holders must be changed as a set Left and Right holders Removing the holders 1 Open the cover and both tube holders...

Page 11: ...ot take care about the following explanations there is the risk of a damaged hose which can cause a leackage Step 1 Press the hose on the back side down to the bottom with both tumbs Check the hose po...

Page 12: ...rect position and has to be reinserted Check again the correct position of both hoses Step 5 Press both clamps sufficently down to grip the tubes Step 6 Finally close the blue clamp If both hoses are...

Page 13: ...erent types of hoses types of hoses types of hoses types of hoses It is possible to weld thermoplastic tubings like C Flex Raumedic FluiSoftTM Pharmed and Sanipure It is not possible to weld non therm...

Page 14: ...nation temperature welding temperature welding time and the date and time 7 3 7 3 7 3 7 3 Printing of last 10 welding protocols Printing of last 10 welding protocols Printing of last 10 welding protoc...

Page 15: ...installed Check that the surface of contact plate blue holder and the contact pins in the BioWelder are clean Depyrogenation temperature can not be reached Has the blade been changed in the right cyc...

Page 16: ...e limitation heater Blade is not able to reach the depyrogenation temperature in between the programmed 90 sec Legend Z axis corresponds to the stroke X axis corresponds to the red holder Y axis corre...

Page 17: ...irs must be done by a factory service representative Exception is the cover which can be exchanged by the client itself 9 3 9 3 9 3 9 3 Calibrat Calibrat Calibrat Calibration ion ion ion The unit has...

Page 18: ...are available as standards Other sizes can be provided upon The maximum tubing O D is determined by the cutting blade width This is currently restricted to 3 4 inch O D max OD OD OD OD ID ID ID ID Wa...

Page 19: ...ing Some of the tubing brands that have been tested are listed below The unit cannot be used to join silicone tubing or PTFE Pharmed Ideal very high purity tubing Can be autoclaved or SIP Long life in...

Page 20: ...down arrow English and German 6 As soon as you have chosen the language press MODE 7 The BioWelder is now ready for welding Set date and time Set date and time Set date and time Set date and time 1 P...

Page 21: ...t form of the manual for the calibration holder Short form of the manual for the calibration holder Clean the Infrared sensor with a cotton stick and alcohol Choose the program Temp validating in the...

Page 22: ...re indicated in the display Insert a new blade in the way displayed Insert the Calibration Holder very carefully do not touch the thermocouple and close the holder afterwards Measuring instrument has...

Page 23: ...t of range is where you can see a high temperature decrease During this phase you don t see big temperature jumps Afterwards the unit cools down the blade sufficiently to a safe temperature for the op...

Page 24: ...the prior written permission of Sartorius Stedim Biotech GmbH The status of the information specifications and illustrations in this manual is indicated by the date given below Sartorius Stedim Biote...

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