Sartorius stedim BioWelder User manual

Operation Manual
Operation ManualOperation Manual
Operation Manual
BioWelder®
85030-531-87

2
Content
ContentContent
Content
1.
1.1.
1. Manual
ManualManual
Manual 2
1.1 Proper Use 2
1.2 Patents 2
2.
2.2.
2. Introduction
IntroductionIntroduction
Introduction 4
2.1 Features 4
2.2 Safety 4
2.3 Restrictions 4
3.
3.3.
3. Function
FunctionFunction
Function 4
3.1 Operation principle 5
4.
4.4.
4. In tallation
In tallationIn tallation
In tallation 7
4.1 Scope of delivery 7
4.2 Setting up 7
4.3 hoose the language 7
4.4 Setting the date and time 7
5.
5.5.
5. Operation
OperationOperation
Operation 8
5.1 ontrols 8
5.2 Operation procedure 8
5.3 Insert hoses 9
5.4 Insert and remove blades 9
5.5 How to remove the hose 10
5.6 How to change the tube holders 10
5.7 Insert 3/4” hose 11
6.
6.6.
6. Qualtity Control
Qualtity ControlQualtity Control
Qualtity Control 13
6.1 Inspecting weld quality 13
6.2 Using different types of hoses 13
6.3 Welding different parameters 13
7.
7.7.
7. Printer
PrinterPrinter
Printer 14
7.1 Accessories 14
7.2 Printout 14
7.3 Printing of last 10 welding
protocols 14
8.
8.8.
8. Trouble Shooting
Trouble ShootingTrouble Shooting
Trouble Shooting 15
8.1 Emergency lid release 15
8.2 Temperature sensor 15
8.3 Trouble isolation table 15
8.4 Error codes 16
8.5 Solutions 16
9.
9.9.
9. Maintenance
MaintenanceMaintenance
Maintenance 17
9.1 Maintenance 17
9.2 Repair 17
9.3 alibration 17
10.
10.10.
10. Specification
SpecificationSpecification
Specification 18
10.1 Fuser 18
10.2 Hoses 18
Appendix
Appendix Appendix
Appendix 1
11
1
Program and holder codes 19
Appendix 2
Appendix 2Appendix 2
Appendix 2
ompatible hoses 19
Appendix 3
Appendix 3Appendix 3
Appendix 3
Short instruction 20
Appendix 4
Appendix 4Appendix 4
Appendix 4
Short form of the manual
for the calibration holder 21
1.
1.1.
1. Manual
ManualManual
Manual
Please read this manual carefully.
It includes important information
for the safe and successful use of
the BioWelder®.
1.1
1.11.1
1.1 Proper U e
Proper U eProper U e
Proper U e
BioWelder® was exclusively
developed, constructed and built
for the industrial and commercial
purpose of connecting
thermoplastic tubing in
pharmaceutical and
biotechnological production and
laboratory operations.
The unit is not intended for use in
or with explosive atmospheres!
The system is exclusively designed
for the purpose defined above.
Any other application above or
beyond this or any modifications
to the unit without the written
permission of the manufacturer
is not considered proper use.
Sartorius Stedim Biotech cannot
assume liability if BioWelder® Units
integrity are subjected to improper
use or improper operation.
Sartorius Stedim Biotech is not
liable for any damages resulting
therefrom. The operator bears the
sole risk.
Proper use also includes
compliance with operating,
inspection and maintenance
conditions prescribed by the
manufacturer. Non-compliance
with the warnings in the
operating instructions and instal-
lation instructions, in particular,
constitutes improper use of the
equipment. Only EM -tested
control leads and accessories may
be used. Units may only be
returned in their original boxes
or appropriate secure packaging.
No liability can be accepted for
transport damage.
1.2
1.21.2
1.2 Patent
PatentPatent
Patent
European patents pending.
BioWelder® is a trademark.
opyright Sartorius Stedim Biotech.
The manufacturer reserves the right
to make any changes and
improvements in the product and
process described in this manual at
any time without notice.
All registered trademarks and
patents are the property of their
respective owners.

3
2.
2.2.
2. Introduction
IntroductionIntroduction
Introduction
The BioWelder® is working with a
thermal welding cycle that does not
require the use of a laminar flow.
In this welding process the blade
is kept sterile and endotoxin free
throughout the whole process
in accordance to the reaction
equation and the Arrheniussatz
through the use of constant time
and temperature (Wallhäuser, the
D-Value resistence indicator for
bacillus subtilis, is less than 1 sec
at 200° dry heat). The inserted
hoses will be cut by a blade and
then fused together through the
unit. The total process will take
place under sterile conditions.
The cycling process is completely
automated and will only be
released after a complete cycle.
Different programmable holders
make it possible to weld
thermoplastic hoses of the same
type together(such as -Flex®,
Sanipure®, Pharmed®) with
diameters of 6.4 mm (1/4”) up to
19.0 mm (3/4”).
2.1
2.12.1
2.1 Feature
FeatureFeature
Feature
– Fully automated operation
– Welds thermoplastic tubing up to
3/4 inch O.D
– Preinstalled settings for -Flex®,
Raumedic® FluiSoftTM, AdvantaPure
AdvantaFlex®, Pharmed® and
Sanipure® tubing
– True thermal weld provides
exceptional strength
– Aseptic connection without
a laminar flow hood
– Data output by a printer
– ompact design, portable
– Easy to validate, with validation
equipment
– an weld many different tube
diameters
2.2
2.22.2
2.2 Safety
SafetySafety
Safety
The device may be used
by children over the age of
8 years of age and by people
with reduced physical,
sensory or mental
capabilities, but only after
they have been instructed
about how to use the device
safely in order to understand
the associated hazards.
hildren must not be
allowed to play with the
appliance. leaning and
maintenance of the
equipment should not be
done by children without
adult supervision.
The blade reaches over 400°
during the welding cycle! To avoid
possible burns DO NOT open the
access door unless it is released.
There will be an automatical
release of the cover as soon as the
blade cooled down sufficiently.
Make sure that the unit is
unplugged before performing
any maintenance or adjustments.
Use only tubing that is compatible
with the unit. Please consult
Sartorius Stedim Biotech for a list
of tubing types that have been
tested. Only use BioWelder® cutting
blades. For optimal operation, do
not reuse blades. Do not attempt
to connect liquid-filled tubing, or
drop liquid into the unit.
2.3
2.32.3
2.3 Re triction
Re trictionRe triction
Re triction
The BioWelder® has been tested to
produce welds of sufficient quality
and strength to permit sterile
transfers.
Example validation protocols and
test results are provided for
reference. However, it is the
responsibility of the end user to
verify and validate the suitability
of this device for their application.
Under no circumstances can data
in this manual be submitted to any
regulatory agency in support of a
clinical product without specific
written permission from the
manufacturer.
The connection made by the
BioWelder® may not be satisfactory
for your application. It is the user’s
responsibility to determine the
suitability of the machine.
onnections should be carefully
inspected before use, as even the
best equipment always has the
possibility of mechanical or
electrical failure.
The BioWelder® has been
programmed for use in room
temperature (20-30° )
The Biowelder unit can be
programmed with maximum
3 parameter sets. When ordered
without any mention, the
Biowelder comes with -Flex®,
PHARMED® BPT and Sanipure® 60.
The unit can be ordered with other
parameter sets. In that case, please
specify the parameter sets you
want to have in the unit and the
ones you want to have removed.

4
Interchangable tube holders
3.
3.3.
3. Function
FunctionFunction
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° 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.

5
3.1
3.13.1
3.1 Operation principle
Operation principleOperation principle
Operation principle
Step 1:
Hoses have to be installed in
the tube holders. Holders have to
be closed then. Now insert the
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
sterility.
Step 4:
The blade returns to the start
position and the tubing is
simultaneously pushed together
to form the connection.
Step 5:
Discard the used blade and
cut tubing ends. Remove the
connected tubing.

6
The four tube holder y tem
The four tube holder y tem The four tube holder y tem
The four tube holder y tem
(TC holder)
(TC holder)(TC holder)
(TC holder)
Step 1:
4 Hoses have to be installed in the
tube holders. Holders have to be
closed then. Now insert the blade.
The 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
against the cut tubing to ensure
sterility.
Step 4:
The blade returns to the start
position and the tubing is
simultaneously pushed together
to form the connection.
Step 5:
Discard the used blade, cut tubing
ends and both self-contained
tubes. Remove the connected
tubing.

7
4.
4.4.
4. In tallation
In tallationIn tallation
In tallation
4.1
4.14.1
4.1 Scope of delivery
Scope of deliveryScope of delivery
Scope of delivery
Remove the Sterile Tube Fuser from
the shipping container. You should
have the following items:
– BioWelder® Sterile Tube Fuser
– Power cable (if ordered)
– Tube holders
(according to order)
– Blade remover
– Q samples made with your unit
– Manual D
– Printer (if ordered)
– Validation equipment
(if ordered)
– 10 blades
– Documentation according 421 S00
– Short manual
A set of standard tubing holders
according to client order (7 sizes
available) will already be installed
in the machine. You may have
ordered additional holders to join
other tubing diameters. heck if
these are present.
Remove any tape and packaging
material from the unit.
4.2
4.24.2
4.2 Setting up
Setting upSetting up
Setting up
The BioWelder® is designed to be
portable and can be moved to
different locations. The instrument
is designed for normal laboratory
environments and must be
protected from splashes or dusty
operations.
The unit is able to recognize the
voltage automatically and needs
115/230 VA (1A).
onnect the supplied power cable
to the connector at the rear of the
instrument.
4.3
4.34.3
4.3 Choo e the language
Choo e the languageChoo e the language
Choo e 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”. Use the up and
down arrow to change the values
of numerals and the right arrow
to change the decimal place (start
with value “2”, press then right
arrow to change to the second
value, enter “6”, press right arrow
and enter now “4”). onfirm
password with right arrow.
Press then right arrow 2 times.
With up or down you can choose
the language: german or english.
To confirm press MODE.
The unit is now ready for welding.
4.4
4.4 4.4
4.4 Settin
SettinSettin
Setting the date and time
g the date and timeg the date and time
g the date and time
You can set the date and time on
the device. To access this program
menu, press MODE followed by the
right arrow key. Now enter the
password. To do this you need the
up and down arrow keys to enter
the digits and the right arrow key
to change the decimal places (you
begin by entering 2., then press the
right arrow key to move to the 2nd
place, now enter 6, then press the
right arrow key and you can select
the 3rd place, now enter 4). onfirm
“264” with the right arrow key.
Finally you have to press the right
arrow key 4 times in quick
succession.
You can now enter the date and
local time using the up, down, left
and right arrow keys.
Press MODE to confirm. The device
is now ready for welding.

8
5.
5.5.
5. Operation
OperationOperation
Operation
5.1
5.15.1
5.1 Control
ControlControl
Control
Normal operation is performed by
closing the cover. The L D display
provides prompts and process
information.
The URSOR keypad is for the
change of hose types. The main
power switch is located at the rear
of the unit.
Warm up the BioWelder® for a
first test weld and subject the
connected tube for Q !
5.2
5.25.2
5.2 Operation procedure
Operation procedureOperation procedure
Operation procedure
Step
StepStep
Step U er action
U er actionU er action
U er action Re pon e
Re pon eRe pon e
Re pon e LCD Di play
LCD Di playLCD Di play
LCD Di play
1
Press Main switch: ON.
lose the cover to start the initial phase.
heck that the unit is set to the correct
program and the correct holders are placed
in the BioWelder®. To change the hose type
press MODE, the right arrow and enter “264”
by pressing up and down arrow.
To leave this menu press MODE.
The L D will show a message.
1. Remove knife
2. Remove hose
3. lose cover
2
lean the outside of
the hoses 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:
heck that the hoses are evacuated.
lose both tube holders simultanuoasly
and close the cover.
After the release of the cover remove
blade and hoses. lose tube holders and
cover. The unit returns to the start
position.
The blade is heated up to the
depyrogenation temperature and
the temperature is held for 5 sec.
Afterwards the blade is
cooled down to the welding
temperature. After reaching this
temperature the blade slides down and
cuts both hoses. The blue tube holder
slides sideways till hoses reach
alignment. Both hoses are pushed
together to fuse them.
The blade is cooled down. After a
succesful end of the welding cycle the
display shows the fulfilled program and
the cover is released.
1. Insert hose
Hose type notice and
hose holder type
2. Insert blade
3. lose cover
Depyrogenation
ooling down to welding
temperature
Welding
ooling
1. Remove blade
2. Remove hose
3. lose cover
Important:
Important:Important:
Important:
over of the unit must be closed during operation.
The cover is released after fulfilling the welding cycle and the blade is cooled.

9
Insert and remove blades
temperature sensor
Caution:
Caution: Caution:
Caution:
The blade has sharp edges.
Hold the blades from the sides
only.
5.3
5.35.3
5.3 In ert ho e
In ert ho eIn ert ho e
In ert ho e
1. Open the cover
2. lean the outside of the tubing area to be connected using a suitable
disinfectant.
3. Place the tubing firmly in the holders. The tubing ends must protrude
beyond each holder.
4. lose both tube holders.
5.4
5.45.4
5.4 In ert and remove blade
In ert and remove bladeIn ert and remove blade
In ert and remove blade
Insert blades
Remove a new cutting blade from its packaging. Hold 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 temperature sensor. Insert blades into these clips
The point on the blade must
show to the temperature sensor.
– Edge with curved corners should
face up
– Please make sure that the dot
matches to the temperatur sensor
To remove a blade:
To remove a blade:To remove a blade:
To remove a blade:
First open the cover and then attach the blade remover. You remove the blade by
pressing to the right and pulling.
Biowelder until the serialnumber RW1299 have a blade holder with runners.
Biowelder from the serial number RW1300 are equipped with balls, which the
blade pinches, it does not change the overall approach to the welding.

10
Lift the holder out
5.5
5.55.5
5.5 How to remove the ho e
How to remove the ho eHow to remove the ho e
How to remove the ho e
1. First remove the used blade and discard.
2. Open both tube holders
3. Remove the tubing and discard the cut ends.
4. lose the cover to reset the unit to the start position
5.6
5.65.6
5.6 How to change the tube holder
How to change the tube holderHow to change the tube holder
How to change the tube holder
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.
2. Take out both lower halves of the tube holders
3. Take out both upper halves of the tube holders
Installing the holders:
1. Open the cover.
2. Set both upper halves, then both lower halfs of the tube holders.
The tube holders are coded, the unit recognizes automatically the holder type
and chooses the correct program.
Please insert only a well matched set. heck also Appendix 1 with standard
holders. heck also the hose program on the display.

11
5.7
5.75.7
5.7 In ert the 3/4” ho e
In ert the 3/4” ho eIn ert the 3/4” ho e
In ert the 3/4” ho e
Caution!
Caution!Caution!
Caution!
In ert the 3/4” ho e carefully!
In ert the 3/4” ho e carefully!In ert the 3/4” ho e carefully!
In ert the 3/4” ho e carefully!
The picture on the left shows the danger inserting this hose diameter. If you do
not 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.
heck the hose position in both holders.
Step 2:
With both thumbs slide to the outside simoutanously and press the holder to the
bottom at the same time. With the upper holders you can fix the hose behind.
Step 3:
The hose in front position can be fixed in the way that it fits perfectely to the
holder. Press it down and to the back side to correct position.

12
Step 4:
Press the upper holder down as the lower can be fixed easily.
If this needs a lot of force, the hose at the back side is not in the correct position
and has to be reinserted.
heck 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 inserted correctly it needs no extra
force to close the clamps.
Step 7:
Avoid any forces on the hose in all directions during the welding process!

13
6.
6.6.
6. Quality Control
Quality ControlQuality Control
Quality Control
6.1
6.16.1
6.1 In pecting weld quality
In pecting weld qualityIn pecting weld quality
In pecting weld quality
The BioWelder® is designed to make reproducible and reliable connections,
however it is still critical to inspect the weld prior to use.
Important:
Important:Important:
Important:
Allow the weld to cool down for 2-3 minutes before inspection to achieve optimal
strength.
1. Axial alignment
heck that the tubing is axially aligned. If the tubing is offset, the weld will
be weaker on one side. Do not use such welds. ontact your Service
Representative to realign the unit.
2. Uniform weld
heck that you see a flange all around the weld. This indicates that the weld is
uniform in the radial direction. If you do not see a flange around the weld, discard
the weld. Make sure that you are using the correct tubing. If you are unable to get
a uniform flange contact your Service Representative for help.
3. Good tensile strength
Pull GENTLY at the weld. It should not come apart or start to crack
6.2
6.26.2
6.2 U ing different
U ing differentU ing different
U ing different type of ho e
type of ho etype of ho e
type of ho e
It is possible to weld thermoplastic tubings like -Flex®, Raumedic® FluiSoftTM,
Pharmed® and Sanipure®.
It is not possible to weld non-thermoplastic formulations such as PTFE, silicone,
or natural rubber. A list of compatible tubing is provided in the Appendix 2.
Different tube formulations have varying melt points. Most tubes can be joined
satisfactorily using the default settings. Your machine i et to the tube type
Your machine i et to the tube type Your machine i et to the tube type
Your machine i et to the tube type
you elected on your order.
you elected on your order.you elected on your order.
you elected on your order.
6.3
6.36.3
6.3 Welding different parameter
Welding different parameterWelding different parameter
Welding different parameter
The BioWelder® is capable of joining tubes of various outer diameters. A set of
tubes holders specific to each tubing outer diameter must be purchased. These
holders are available for a minimum tubing outer diameter (OD) of 1/4 inch to a
maximum tubing OD of 3/4 inch.
Each holder set consists out of two blue (left) and two red (right) tube holders.
All four holders must be changed as a set. Holders can simply be snapped in and
out. The machine reads the coded holders and runs the appropriate stored
program.

14
7.
7.7.
7. Printer
PrinterPrinter
Printer
7.1
7.17.1
7.1 Acce orie
Acce orieAcce orie
Acce orie
– Power supply cable
– onnecting cable to BioWelder®
– itizen BM 910
– 2 paper rolls
– 2 ink ribbon
– Manual itizen
For more information, please check the user’s manual of the itizen Dot Matrix
Printer Model BM 910, which is included in the delivery.
7.2
7.27.2
7.2 Printout
PrintoutPrintout
Printout
If a printer is connected a printout is produced after each welding. This includes
the serial number of the device, hose type, size, depyrogenation temperature,
welding temperature, welding time, and the date and time.
7.3
7.37.3
7.3 Printing of la t 10 welding protocol
Printing of la t 10 welding protocolPrinting of la t 10 welding protocol
Printing of la t 10 welding protocol
onnect printer to the BioWelder® as shown in picture on the left. To print the
last 10 welding protocols open the “printing” menu on the display. Press MODE
and afterwards the right arrow. Enter password “264” with the up and down arrow.
With right arrow change decimal place (check also page 7: hoose language).
onfirm password with right arrow. Press right arrow once and you reach the
“printing” menu. When you press the down arrow printing will be started.
Your BioWelder® is ready now for the next welding.

15
8.
8.8.
8. Trouble Shooting
Trouble ShootingTrouble Shooting
Trouble Shooting
8.1
8.18.1
8.1 Emergency lid relea e
Emergency lid relea eEmergency lid relea e
Emergency lid relea e
If it happens that the cover does
not release and it is necessary to
open the cover, use the following
procedure:
Power on procedure:
Press all three left buttons at the
same time and the cover will open
(this only happens if the unit and
the blade have been cooled down).
8.2
8.28.2
8.2 Temperature en or
Temperature en orTemperature en or
Temperature en or
The temperature sensor can be
cleaned with a cotton wool stick
which is moistened with alcohol
after an interruption.
8.3
8.38.3
8.3 Trouble i olation table
Trouble i olation tableTrouble i olation table
Trouble i olation table
L D display is not lit
heck that instrument is plugged in
heck that the power switch is ON
Unit fuse has blown. ontact Service Representative for help
The first welding is always unusable heck that the BioWelder® is not installed on a cold or windy place
Unit does not recognize that
the holders are installed heck that the surface of contact plate (blue holder) and the contact pins in the BioWelder® are clean
Depyroge
nation temperature
can not be reached
Has the blade been changed in the right cycle?
Exchange blade and repeat the welding.
If this occurs again please contact Service Representative
over does not open
heck that the power switch is ON
heck that the process is finished
See the next section for instructions on resetting the unit.
Welding insufficient
Is the right hose type programmed?
Did you choose the right hose diameter?
Is the blade bent?
Is the bla
de correctly locked in position in the blade holder?
Is the right side of the blade showing in direction to the temperature
sensor (point in direction to the temperature sensor)?
Is the holder size on the printout identical to the holder size installed?
I
s the welding joint burned?
Has the right hose program been chosen for the welded hose?
Did you clean the temperature sensor as indicated in maintenance
chapter?
Printer does not
work
Is the printer connected to power supply?
Is the printer switched on?
Is the function SEL activated? (green LED is on)
The dip switches have to be in the showed position.
Date is incorrect
hange the date by referring to the information provided in the quick
reference manual

16
8.4
8.48.4
8.4 Error code
Error codeError code
Error code
ERROR ZAXIS
Time limitation elevating motor (Z-axis)
Z-axis did not reach the programmed position in between 8 sec.
ERROR YAXIS
Time limitation slide motor (y-axis)
Y
-axis did not reach the programmed position in between 8 sec.
ERROR XAXIS
Time limitation eccentric motor (X-axis)
X
-axis did not reach the programmed position in between 5 sec.
ERROR HEATER
Time 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: corresponds to the blue holder
8.5
8.58.5
8.5 Solution
SolutionSolution
Solution
In the event that the machine
malfunctions during the welding
process, the cycle will not be
completed.
Use the keypad to open the cover
and remove the blade and tubing.
Turn off the unit and wait
10 seconds before switching on
again. This should reset the unit.
If the program continues to
malfunction please contact Service
Representative.

17
9.
9.9.
9. Maintenance
MaintenanceMaintenance
Maintenance
9.1
9.19.1
9.1 Maintenance
MaintenanceMaintenance
Maintenance
Press MODE to check the amount of realized weldings. The BioWelder® is designed
in the way that there is no periodical service necessary.
lean the temperature sensor after all 30 to 40 weldings with a cotton wool stick
and alcohol.
We recommend a periodic cleaning of the machine, using a small handheld
vacuum cleaner.
9.2
9.29.2
9.2 Repair
RepairRepair
Repair
All repairs must be done by a factory service representative.
Exception is the cover which can be exchanged by the client itself.
9.3
9.39.3
9.3 Calibrat
CalibratCalibrat
Calibration
ionion
ion
The unit has been calibrated before shipping.
There are no user calibration procedures. Prior to use, the machine should be
tested by making a few trial welds. These welds should be carefully examined to
determine that the machine is operating satisfactorily.
For units which will be used in a GMP process there is a calibration unit available
together with a calibration procedure manual. Please contact Sartorius Stedim
Biotech for more information. A condensed version can be found in appendix 4
on page 20.

18
10.
10.10.
10. Specification
SpecificationSpecification
Specification
10.1
10.110.1
10.1 BioWelder
BioWelderBioWelder
BioWelder®
®®
®
Power
240/115 VA 1 Amp max.
Dimensions
300 + 300 + 220 mm ( L + W + H)
Weight
10.5 kg
Max. tubing OD
3/4 inch (19 mm)
Min. tubing ID
1/4 inch (6.4 mm)
Typical fusing cycle 1–1.5 minutes
Environment tempe
rature 20 to 30° (optimal 22° )
Relative humidity
20 to 80 % (optimal 60%)
Approvals E, EMV
utting blade Single use, packaged in 100 Qty.
Preinstalled settings for
-Flex®, Pharmed®, Sanipure®
10.2
10.210.2
10.2 Ho e
Ho eHo e
Ho e
Following holder sizes 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
ODOD
OD ID
IDID
ID Wall
WallWall
Wall
6.4 mm | 1/4 inch 3.2 mm | 1/8 inch 1.6 mm | 1/16 inch
8.0 mm | 5/16 inch 4.8 mm | 3/16 inch 1.6 mm | 1/16 inch
9.5 mm | 3/8 inch 6.4 mm | 1/4 inch 1.6 mm | 1/16 inch
11.1 mm | 7/16 inch 8.00 mm | 5/16 inch 1.6 mm | 1/16 inch
12.7 mm | 1/2 inch 9.5 mm | 3/8 inch 1.6 mm | 1/16 inch
15.9 mm | 5/8 inch 9.5 mm | 3/8 inch 3.2 mm | 1/8 inch
19.0 mm | 3/4 inch 12.7 mm | 1/2 inch 3.2 mm | 1/8 inch
Sartorius Stedim Biotech guarantees that thermoplastic tubing like -Flex®, Pharmed® and Sanipure® can be joined with the
BioWelder®. Various tubing types and settings can be user-programmed into the unit..

19
Appendix 1
Appendix 1Appendix 1
Appendix 1
Program and holder code
Program and holder codeProgram and holder code
Program and holder code
Each set of tubing holders is coded
so that the machine can recognize
the installed holder size. Each
holder can be programmed with up
to two tubing types with individual
cutting and welding temperatures
as well as timing and motion
control parameters. The programs
are stored in non-volatile memory
and will be retained even if power
is removed.
The L D will show the hose type
selected as shown on the left.
Press MODE then right arrow
and enter the password “264”.
Press again the right arrow. To
change the hose type press up or
down. Press MODE again to go
back to the welding program.
Nominal
NominalNominal
Nominal
tubing OD
tubing ODtubing OD
tubing OD
Standard
Standard Standard
Standard
holder code
holder codeholder code
holder code
5/8 inch 1
3/4 inch 2
7/16 inch 3
1/4 inch 4
5/16 inch 5
3/8 inch 6
1/2 inch 7
1/4 inch T 10
3/8 inch T 11
5/16 inch T 12
Appendix 2
Appendix 2Appendix 2
Appendix 2
Compatible ho e
Compatible ho eCompatible ho e
Compatible ho e
The BioWelder® is designed to join thermoplastic tubing. 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. an be autoclaved or SIP.
Long life in peristaltic pumps. The standard BioWelder® is
optimized for Pharmed® BPT as hose type 1.
-Flex® Advantage of translucency and lower cost. Not as strong as
Pharmed®. Works fine in the BioWelder® but needs lower blade
temperature setting. In standard machines is -
Flex® 072, 082 and
374 set as hose type 2. There are many types of -Flex® tubing
and each subtype can be optimized to best performance.
Sanipure® omparable with -Flex® but with improved life time in
peristaltic pumps. Works fine with the BioWelder® but requires
a low blade temperature setting. On all standard BioWelder® units
is Sanipure® 60, BDF and AF installed as hose type 3.
FluiSoft
TM
AdvantaPure
AdvantaFlex®
In standard machine, set as hose type 2 (same than
-Flex®).
We will develop optimal welding programs for different thermoplastic tubing,
including the joining of dissimilar tubing upon request.
The Biowelder unit can be programmed with maximum 3 parameter sets. When
ordered without any mention, the Biowelder comes with -Flex®, PHARMED® BPT
and Sanipure® 60. The unit can be ordered with other parameter sets. In that case,
please specify the parameter sets you want to have in the unit and the ones you
want to have removed.

20
Appendix 3
Appendix 3Appendix 3
Appendix 3
Short in truction
Short in tructionShort in truction
Short in truction
Choo e of the ho e type
Choo e of the ho e typeChoo e of the ho e type
Choo e of the ho e type
1. Press MODE and then the right
arrow.
2. With “up” and “down” arrow
enter the password “264”.
3. onfirm with right arrow.
4. hoose hose type with “up” and
“down” arrow in standard units:
1 (Pharmed® BPT), 2 ( -Flex®
072/082/374) or (FluiSoftTM)
3 (Sanipure® 60/BDF/AF).
5. As soon as you have chosen the
hose type press MODE.
6. The BioWelder® is now ready for
welding.
Choo e the language
Choo e the languageChoo e the language
Choo e the language
1. Press MODE and then the right
arrow.
2. With “up” and “down” arrow
enter the password “264”.
3. onfirm with right arrow.
4. Press the right arrow twice.
5. hoose language with “up” and
“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 timeSet date and time
Set date and time
1. Press MODE and then the right
arrow.
2. With “up” and “down” arrow
enter the password “264”.
3. onfirm with right arrow.
4. Press the right arrow four times.
5. hoose year, month, day, hours
and minutes with right arrow and
set desired value with “up” and
“down” arrow.
6. As soon as you have set date
and time press MODE.
7. The BioWelder® is now ready for
welding.
Print out of the la t 10 welding
Print out of the la t 10 welding Print out of the la t 10 welding
Print out of the la t 10 welding
prot
protprot
protocol
ocolocol
ocol
1. Press MODE and then the right
arrow.
2. With “up” and “down” arrow
enter the password “264”.
3. onfirm with right arrow.
4. Press once the right arrow.
5. Press “down” arrow to start the
printing process.
6. As soon as the printer has
finished printing press MODE.
7. The BioWelder® is now ready for
welding