Sartorius BioPAT Xgas User manual

Operating Instructions | Betriebsanleitung
BioPAT
®Xgas
85032-544-12
85032-544-12

English page 3
Deutsch Seite 42
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Contents
Operating Instructions BioPAT
®Xgas 3
Contents
1 Introduction .............................................................5
1.1 Function ..............................................................5
1.2 Target Group..........................................................5
1.3 Notes on Using these Instructions ....................................5
2 Safety Instructions .......................................................7
2.1 General Information ..................................................7
2.2 Authorized Personnel.................................................7
2.3 Intended Usage .......................................................7
2.4 Limitations of Use and Misuse ........................................8
2.5 Process-related Hazards ..............................................9
3 Design and Function ....................................................10
3.1 Measurement Principles .............................................10
3.1.1 Pressure Measurement .......................................12
3.1.2 Humidity Measurement ......................................12
 ............................................12
  .............................................12
4 Installation ..............................................................13
4.1 Equipment ...........................................................13
4.1.1 Unboxing and assembling ....................................14
4.2 Setup.................................................................17
4.3 Assembly.............................................................17
4.4 Connection ..........................................................18
4.5 Arrangement on the Bioreactor and Assembly.......................24

Contents
4 Operating Instructions BioPAT
®Xgas
5 Operating Information..................................................25
5.1 Safety Instructions .................................................. 25
5.2 In-process Exhaust Air Analysis ..................................... 26
5.2.1 Switching on the BioPAT®Xgas .............................. 26
5.2.2 In-process Measurement .................................... 28
5.2.3 Sensor Status Display via LEDs ..............................30
5.3 Troubleshooting......................................................31
5.3.1 Faults or Malfunctions from Moisture in the Exhaust Air .....31
5.3.2 Leaktightness Test............................................32
6 Maintenance and Service ...............................................33
6.1 Maintenance by the Customer.......................................33
6.1.1 Calibration....................................................33
6.1.2 Filter Replacement .......................................... 34
7 Appendix................................................................36
7.1 Calibration Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
8 Technical Data ..........................................................37
9 Disposal................................................................40
9.1 Information on Decontamination ...................................40
9.2 Dispose of Device and Parts ........................................40
9.2.1 Information on Disposal .....................................40
9.2.2 Disposal......................................................40
10 Conformity Documents .................................................41

Operating Instructions BioPAT
®Xgas 5
Introduction
1 Introduction
1.1 Function
These operating instructions describe the safe installation and use of the
BioPAT®Xgas.The operating personnel must read these instructions prior to
operational startup. These instructions should always be available at the
workplace.
1.2 Target Group
These operating instructions are designed for qualified personnel. Only
qualified personnel may set up BioPAT®Xgas, connect it to the bioreactor or
perform in-process operation or maintenance.
1.3 Notes on Using these Instructions
All information in these operating instructions considers the state of the art,
the applicable standards and guidelines, and our many years of experience
and knowledge.
These operating instructions provide you with all the information necessary to
install and operate the BioPAT®Xgas (referred to as “device” in the following).
The operating instructions must be read and used by all persons entrusted
with the operation, service, cleaning, and troubleshooting of the device.
This applies particularly to the safety instructions listed.
t Please read these operating instructions carefully and completely before
using this device.
t These instructions are part of the product. Keep them in a safe and easily
accessible place near the device’s site of installation.
t If the instructions should be lost or misplaced, please contact Sartorius
Stedim Biotech for a replacement or download the latest version from our
website: www.sartorius.com

6 Operating Instructions BioPAT
®Xgas
Introduction
Symbols Used
As a means of instruction and direct warning
against hazards, all text statements to be particu-
larly noted in these operating instructions will be
marked as follows:
This symbol denotes a possible danger with risk
that moderate or minor injury may result if it is
not avoided.
This symbol denotes a danger with low risk that
could result in property damage if it is not avoided.
This symbol indicates useful information or a
function|setting on the device, or that caution
should be exercised while working.
The following presentations will also be used:
Texts that follow this mark are lists.
t Texts that follow this mark describe
activities that must be carried out in
the specified order.
y Texts that follow this mark describe
the result of an action.
“ ” Texts in quotes are references to other
chapters or sections.
CAUTION
IMPORTANT

Operating Instructions BioPAT
®Xgas 7
Safety Instructions
2 Safety Instructions
2.1 General Information
Sartorius Stedim Biotech supplies the BioPAT®Xgas after careful testing in
ready-for-operation condition.
This manual contains instructions for the safe operation of the BioPAT®Xgas.
You may only operate the device under conditions that comply with the
specifications stated in this manual and the information on the manufacturer’s
ID label.
2.2 Authorized Personnel
The following persons may carry out the actions described here:
Operations Persons
Assembly and connection at|to
the bioreactor; function test, basic
calibration during servicing and
maintenance
Trained and qualified personnel of
the operator or service technicians
of Sartorius Stedim Biotech
Operation, in-process 1-point
calibration
Personnel who has read this
documentation and is familiar with
the operation of bioreactors
Factory maintenance and service Sartorius Service
2.3 Intended Usage
The BioPAT®Xgas is a gas sensor for measuring carbon dioxide and oxygen
contents in the defined concentration range and under the conditions

during biological processes such as fermentations.

8 Operating Instructions BioPAT
®Xgas
Safety Instructions
2.4 Limitations of Use and
Misuse
Danger of malfunctions and damage to the
sensor under impermissible measuring
conditions!
The BioPAT®Xgas is not designed according to
the ATEX Directive.
t Do not use the sensor
in flammable or explosive atmospheres or
with such gases!
in gases with polymers or silicone
components
in gases with halogens like F, Cl, Br etc.,
CFC
in gases with SOx and H2S.
t Prevent water or humidity (RH <75%) from
entering into the sensor when the sensor is
switched on.
t Dry the sensor when humidity condenses in
the exhaust line and condensate has entered
into the sensor.
The BioPAT®Xgas is unsuitable for use as safety
equipment for system gas monitoring or as a gas
warning device. This constitutes misuse.
IMPORTANT

Operating Instructions BioPAT
®Xgas 9
Safety Instructions
2.5 Process-related Hazards
Risk of poisoning for persons when CO2is
released into the room! Risk of inflammation
for flammable materials if gases enriched with
oxygen escape into the room air!
t Determine the max. concentrations of gas
released into the room and evaluate whether
they could lead to hazardous situations, e.g. if
the room ventilation fails.
t Ensure that your work area is well ventilated
or connect the BioPAT®Xgas to the available
exhaust air fittings in your laboratory.
t Check all connections for leaks.
CAUTION

10 Operating Instructions BioPAT
®Xgas
3 Design and Function
The BioPAT®Xgas combines one oxygen and one carbon dioxide sensor
featuring automatic compensation of humidity and pressure into one

adapter past the measuring chambers. During this process, the pressure,
humidity, oxygen and carbon dioxide concentration are measured.
The sensors measure the gases in the concentration ranges and under the


e.g. the DCU systems of bioreactors Biostat®C Plus, B and B-DCU II.
The measurement and control system shows measurements on the display,

measurement and control system.
3.1 Measurement Principles
The analyzer features 4 different measuring components:
1. Pressure measurement
2. Humidity measurement
3. CO2measurement
4. O2measurement

Operating Instructions BioPAT
®Xgas 11
Design and Function
Electronics
Pressure and humidity
measurement
CO2IR sensor
ZrO2O2sensor
For hoses|pipes

Fig.1: Schematic illustration of complete installation
In order to prevent humidity contained in the exhaust air in the BioPAT®Xgas
from condensing, the sensor housing is heated. Warming up prior to initial
startup as well as every time the device is disconnected from the power
supply will take about an hour. The sensorwon’t provide anyvalid readings
during heating.

12 Operating Instructions BioPAT
®Xgas
Design and Function
3.1.1 Pressure Measurement
A piezoresistive silicon pressure sensor is used to
measure the pressure.
3.1.2 Humidity Measurement
A capacitive polymer sensor is used to measure
the humidity.
3.1.3 

detector and the reflection measuring cell (Fig. 2).
The infrared beam is reflected by the gas-filled
measuring adapter. The light, now weakened by

A translucent sapphire disc prevents the optical
components from getting soiled by constituents
of exhaust air.
3.1.4 
The BioPAT®Xgas oxygen sensor is based on an
oxygen pump cell and runs independently of
reference gases. Applying voltage to the cell
moves the oxygen ions from the cathode to the
anode and generates current. Through a diffu-
sion barrier in front of the cathode, a saturation
current is generated by increasing the supply
voltage, which allows measurement of the
ambient oxygen concentration.
Fig.2: Measuring setup of the
CO2sensor
Fig.3: Measuring setup of the
O2sensor

Operating Instructions BioPAT
®Xgas 13
Installation
4 Installation
4.1 Equipment
Danger of malfunctions when damaged during
transport and when operated under process
conditions that do not comply with the device
specifications!
When delivered for orwith bench-top bioreactor
systems, e.g. Biostat®B or B-DCU II, the BioPAT®
Xgas and accessories are packaged in a safe-to-
transport manner.
When delivered with sterilizable-in-place (SIP)
bioreactors, e.g., Biostat®C Plus, the BioPAT®
Xgas sensor is installed on the bioreactor frame.
The sensor accessories are packaged separately
in a safe-to-transport manner.
t Carefully unpack the packaged devices and
the connecting accessories.
t Check if the delivery is complete.
t Check all delivered components for any
damage. If transport damage has occurred,
send a claim as soon as possible.
The equipment supplied with BioPAT®Xgas,
including the connection kit, is comprised of:
The analyzer BioPAT®Xgas.
Flow adapters for connection to the exhaust line.
For bench-top bioreactors: connection hoses,
e.g., silicon hoses with diameter 6 mm, for
connecting the exhaust filter to the BioPAT®
Xgas Sensor.
IMPORTANT
Fig.4: Analyzer, signal cable

connection (A) Spare kit 1:
SB-20-02-0002, Power supply
for BioPAT®Xgas
A

14 Operating Instructions BioPAT
®Xgas
Installation
For sterilizable-in-place (SIP) bioreactors:
installation kit already attached to the biore-
actor frame.
Signal transmission cable to the BioPAT®Xgas
on the control unit.
When delivered with the external power
supply, the male connector must match the
power connection in laboratory. The delivery
contains the matching plug adapter.
A replacement BioPAT®Xgas power supply kit
pack can be ordered from Sartorius Stedim
Biotech (SB-20-02-0002), see “Fig.5: Cable
set included“.
4.1.1 Unboxing and assembling
The flow adapter of the BioPAT®Xgas is not
pre-assembled and will be delivered in a small
box togetherwith the BioPAT®Xgas (fig. 4a).
Before the installation, it must be connected to
the BioPAT®Xgas.
For the assembling you will need (fig. 4b):
1. The BioPAT®Xgas (A)
2. The TORXT20 screwdriver (D)
3. The mounting base plate (C)
4. The flow adapter (E)
5. Bag with 2 flat head screws M4x6 TORXfor
the wall mounting and 4 screws M4x16 TORX
for the flow adapter (B).
6. Bag with flow path filter set BioPAT®Xgas (B).
Fig. 4a: Unboxing
C
D E A
B
Fig. 4b: Preparing the
assembling (B) Spare kit 2:
SB-20-02-0001, Spare part kit
for BioPAT®Xgas

Operating Instructions BioPAT
®Xgas 15
Installation
To assemble the BioPAT®Xgas proceed in the
following steps:
t First, place the filters and gaskets on the

are in the filter set for the BioPAT®Xgas
(SB-20-02-0001, Spare part kit for BioPAT®
Xgas). For each recess there are two different
filters. There is a flat filter (fig. 4c:A) and a
thicker filter (fig. 4c:B). The flat filter is hydro-
phobic and the thicker is the particulate filter.
For each recess there is a gasket, a flat filter
and a thicker filter in the filter set (fig. 4c).
t Insert the flat filter into the recesses (fig. 4e).
t Place the gaskets in the recesses (fig. 4f).
Fig. 4c: Filters
A B
Fig. 4d: Filters and gaskets
Fig. 4e: Insert flat filter
Fig. 4f: Place gaskets

16 Operating Instructions BioPAT
®Xgas
Installation
t Insert the thicker filters into the recesses

might be necessary to push them gently into
place (fig. 4h).
t Now place the 4 TORX screws M4x16 (fig. 4b:
E) in the bores of the BioPAT®Xgas without
screwing. This will make it easier to place the
BioPAT®Xgas on the right spot on the flow
adapter (fig. 4i).
t Place the BioPAT®Xgas on the flow adapter.
Tighten the 4 screws with the screw driver
TORX.
t Put the wall mounting plate on the flow
adapter and use the two flat head screws
M4x6 (fig. 4b: E) to fix the base plate to the
sensor (fig. 4k).
Fig. 4g: Insert second filter
Fig. 4h: Fit in filter
Fig. 4i: Put screws in
Fig. 4j:Tighten screws
Fig. 4k: Fit base plate

Operating Instructions BioPAT
®Xgas 17
Installation
4.2 Setup
Danger of damage to the control and supply unit
of the bioreactor!
The BioPAT®Xgas module weighs approx. 3 kg.
t Do not place the module on the control and
supply unit of the bioreactor and do not
fasten it to its side panels.The housing panels
cannot carry the weight of the BioPAT®Xgas.
4.3 Assembly
When using bioreactor bench-top systems,
mount the BioPAT®Xgas module on a flat surface
with non-slip rubber feet.
t Observe the lengths of the cables and
connection lines.
t Place the BioPAT®Xgas on the work table
next to the bioreactor so that you can
comfortably connect all equipment.
t Mounting the BioPAT®Xgas on a fixed vertical
surface is possible with the approriate 6.6 mm
screws.
When using sterilizable-in-place (SIP) bioreac-
tors, the BioPAT®Xgas module is attached to the
bioreactor frame using an installation kit.
t Avoid contact between the signal cable and
the outer surface of the vessel.
t Ensure that no hot steam is directed at the
sensor and signal cable.
IMPORTANT

18 Operating Instructions BioPAT
®Xgas
Installation
4.4 Connection
Making connections while the BioPAT®Xgas is
still connected to power orwith the wrong kind
of voltage can cause damage!
t Use only cables from the equipment supplied
with the BioPAT®Xgas and|or the bioreactor
equipment. The module is not equipped with
an ON|OFF switch. First, leave the control
unit and|or supply unit of the bioreactors
switched off and|or disconnect the external
power adapter from the mains current. First
connect the cables for the signal transmission
and power supply.
t Connect the exhaust line from the Biostat®B
and B-DCU II.
t Make sure that the lines of the culture
vessel contain no condensation.
t Connect the exhaust line to the BioPAT®
Xgas.
t If exhaust air entering the room air can be
regarded as safe, you can leave the
BioPAT®Xgas outlet open. If the exhaust
air contains gases in potentially hazardous
concentrations, connect the outlet to the
exhaust air fittings in the laboratory.
IMPORTANT

Operating Instructions BioPAT
®Xgas 19
Installation
Connecting the Cables to the Biostat®B and
B-DCU II
t Use only the cables that are especially
designed for this purpose. Observe the
specifications below and the “Technical
Documentation on the Bioreactor“.
t Wait until the BioPAT®Xgas has reached
room temperature.
Connecting the Y cable
t Take the Ycable of the BioPAT®Xgas.
t Connect the female connector with the three
cable outputs to the left plug of the BioPAT®
Xgas.
t Connect the BioPAT®Xgas to the power
supply.
Fig.5: Cable set included

20 Operating Instructions BioPAT
®Xgas
Installation
Connecting to Biostat® B (Serial No. ≤ 1000)
t Connect the analog signal outputs of the
BioPAT®Xgas to the analog inputs on the
Control Tower of the Biostat®B as follows:
t Take the analog Ysignal cable.
t Connect the plug of the Y cable labeled
“Xgas” to the right female connector of the
BioPAT®Xgas.
t Connect the plug of the Y cable labeled
“Ext. Sig.-A” to the female connector
®B.
t Connect the plug of the Y cable labeled
“Ext. Sig.-A” to the female connector
®B.