Asahi KASEI IBD 1K User manual

IBD™ 1K Inline Buffer
Dilution System
User Manual
AEE33X01
Version 1.0
Issued April 22, 2015
Manufactured by
Asahi Kasei Bioprocess America, Inc.
1855 Elmdale Avenue
Glenview, IL 60026 USA
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185013007502

Quick Links
Troubleshooting-Alarms (below)
Prerequisites
In order to operate the IBD™ 1K Inline Buffer Dilution
System in the way it is intended, the following prerequisites
must be fulfilled:
•You must read and understand the safety instructions in
this User Manual and other user documentation.
•You must have a thorough knowledge of the entire
system and processes.
•All operations must be performed by qualified personnel
who are adequately trained.
NOTE: The information contained herein is for the sole use
of the purchaser to whom it has been issued. The release to a
third party or the reproduction of content contained herein is
expressly forbidden without the written authorization of
Asahi Kasei Bioprocess America, Inc.
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Contents
1. Introduction............................................................................................................................1
2. Products Covered...................................................................................................................1
2.1. Specifications..................................................................................................................2
3. Important User Information...................................................................................................3
3.1. Intended Use ...................................................................................................................3
3.2. Regulatory Information...................................................................................................3
3.3. Safety Notices.................................................................................................................4
3.4. Guide to User Manual Conventions...............................................................................4
4. Getting Started.......................................................................................................................4
4.1. Risk Assessment .............................................................................................................4
4.2. General Precautions ........................................................................................................5
4.3. Using Flammable Liquids...............................................................................................5
4.4. Personal Protection .........................................................................................................5
4.5. Site Requirements...........................................................................................................5
4.6. Installing and Moving the IBD-1K.................................................................................7
4.7. System operation.............................................................................................................8
4.8. Maintenance....................................................................................................................8
4.9. Labels..............................................................................................................................9
4.10. Emergency Procedures................................................................................................10
4.11. Handling Power Failure..............................................................................................11
5. General Operation................................................................................................................11
5.1. Startup...........................................................................................................................12
5.2. Login.............................................................................................................................12
5.3. Piping and Instrumentation Diagram (P&ID)...............................................................12
5.4. Process Overview Screen..............................................................................................14
5.5. Trend.............................................................................................................................15
5.6. Process Overview Screen, Manual Mode without Feedback........................................17
5.7. Process Overview Screen, Manual Mode with Feedback.............................................18
5.8. Process Overview Screen, Auto Mode .........................................................................19
5.9. Batch Screen .................................................................................................................20
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5.10. Change Selected Method ............................................................................................21
5.11. Copy Selected Method................................................................................................21
6. Manual Method Programming.............................................................................................22
6.1. Method Parameters .......................................................................................................22
6.2. Step Type......................................................................................................................22
6.3. Step Name.....................................................................................................................23
6.4. Toggle Edit Mode .........................................................................................................23
6.5. Preprogrammed Sequences...........................................................................................23
6.6. Step Type Pause, Parameters........................................................................................26
6.7. Step Type Prime, Parameters........................................................................................26
6.8. Step Parameters.............................................................................................................28
6.9. Step Parameters PID .....................................................................................................30
7. Batch Reports.......................................................................................................................32
8. Advanced Features...............................................................................................................33
8.1. Simulation Mode...........................................................................................................34
8.2. Audit Viewer.................................................................................................................35
8.3. System Settings.............................................................................................................35
8.4. Alarm History ...............................................................................................................36
8.5. Queue Editor.................................................................................................................38
8.6. Date & Time .................................................................................................................41
8.7. Process Alarms Button Footer......................................................................................42
8.8. Steps Alarms Button Footer..........................................................................................42
9. Developing and Running a Method.....................................................................................43
9.1. Manual Presets..............................................................................................................44
9.2. Semi-Automatic Manual Presets...................................................................................45
9.3. Naming Method / Inlets / Outlets..................................................................................46
9.4. Inserting Steps to a Method ..........................................................................................46
9.5. Running a Method.........................................................................................................47
10. References..........................................................................................................................47
Appendix A: 21CFR Part 11 Capability..................................................................................48
Appendix B: Data ....................................................................................................................50
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Appendix C: System Data Backup and Restore Procedure.....................................................51
List of Tables
Table 2-1. Options and catalog numbers for IBD 1K System................................................................................1
Table 3-1. Standards with which the IBD 1K System complies............................................................................3
Table 4-1. Site requirements for installing and using the IBD 1K System ............................................................7
Table 4-2. Low voltage input.................................................................................................................................9
Table 4-3. High voltage input ..............................................................................................................................10
Table 4-4. Description of events that can be expected in the event of a specific power failure...........................11
Table 8-1. Programmed alarms and resolution strategies ....................................................................................36
Table 8-2. User matrix settings............................................................................................................................41
List of Figures
Figure 4-1. Emergency Stop button on the front panel IBD 1K System............................................................11
Figure 5-1. P&ID for the IBD 1K System...........................................................................................................13
Figure 5-2. Process Overview screen...................................................................................................................14
Figure 5-3. Trend analysis control screen............................................................................................................15
Figure 5-4. Multiple Trends windows .................................................................................................................16
Figure 5-5. Check for a running batch from the Data Analysis Tool software....................................................17
Figure 5-6. Designing a manual method by setting control of valves..................................................................18
Figure 5-7. Process Overview control screen ......................................................................................................19
Figure 5-8. Batch screen entry.............................................................................................................................20
Figure 5-9. Method Select screen with more than 200 methods..........................................................................21
Figure 6-1. Method Parameters screen for modifying the method ......................................................................22
Figure 6-2. Method Steps selection of pre-programmed methods.......................................................................23
Figure 6-3. Step Parameters screen for controlling steps (CIP)...........................................................................24
Figure 6-4. Step Parameters screen for setting limits (CIP).................................................................................25
Figure 6-5. Step Parameters screen showing entry of a pause time.....................................................................26
Figure 6-6. Step Parameters screen showing prime input steps...........................................................................27
Figure 6-7. Step Parameters screen showing limits .............................................................................................28
Figure 6-8. Step Parameters screen showing Alarms...........................................................................................29
Figure 6-9. Step Parameters screen showing how to set proportional and integral values ..................................31
Figure 7-1. Batch Reports search result...............................................................................................................33
Figure 8-1. Advanced menu screen .....................................................................................................................34
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Figure 8-2. Simulation screen..............................................................................................................................35
Figure 8-3. System Settings for probes................................................................................................................36
Figure 8-4. Alarm History showing the lists of alarms........................................................................................37
Figure 8-5. Queues screen ...................................................................................................................................38
Figure 8-6. Queue Editor screen..........................................................................................................................39
Figure 8-7. User Administration screen for making changes to user parameters ................................................40
Figure 8-8. Date Time screen for setting time and date.......................................................................................42
Figure 8-9. Running Steps screen........................................................................................................................43
Figure 9-1. Process Overview screen for controlling process steps.....................................................................45
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Products Covered
AEE33X01-1.0
IBD™ 1K Inline Buffer Dilution System User Manual Page 1 of 51
1. Introduction
Featuring a compact 26 in. × 48 in. footprint and equipped to produce flow rates of 60 to
1000 L/h, the IBD™ 1K System sets a new standard for just-in-time-production and reflects
the next step in the evolution of the patented, award-winning buffer blending technology.
Now you can produce dilute buffers on-demand from up to 20× concentrates with the ability
to control flow, pH and conductivity simultaneously to streamline your downstream process.
Process engineers can perform classic dilutions of salt with water for injection (WFI) plus pH
adjustments using acid/base modifiers as well as buffer conditioning recipes with WFI and
acid/base conjugates. By controlling buffer concentration from first-order analogues, the IBD
1K System ensures that the quality of the final output buffer is consistent, regardless of the
variability in concentrate feedstock. In addition, novel blending technology embedded in the
IBD 1K System reduces the amount of time required to reach target setpoints while efficient
rinsing and changeover between buffers minimizes waste. The IBD 1K System is also
equipped with flow based dilution control (optional 2 or 3 flow meters) to accommodate all
needs.
This User Manual provides all of the instructions needed to safely install, operate, maintain
and calibrate the IBD 1K System.
For further information please contact:
Asahi Kasei Bioprocess America, Inc.
1855 Elmdale Avenue
Glenview, IL 60026 USA
Tel: [phone] or 1-800-865-4100
Fax: [phone]
2. Products Covered
The IBD 1K System is available with the following options (Table 2-1). Please note that pH
control is included standard in all models.
Table 2-1. Options and catalog numbers for IBD 1K System
Catalog number Description
IBD1K0013 IBD™ 1K System with 3 Magnetic Flow Meters, 1 Conductivity
IBD1K0014 IBD™ 1K System with 3 Coriolis Flow Meters, 1 Conductivity
IBD1K0023 IBD™ 1K System with 3 Magnetic Flow Meters, 2 Conductivity
IBD1K0024 IBD™ 1K System with 3 Coriolis Flow Meters, 1 Conductivity
IBD1K02-- IBD™ 1K System with 2 Outlet Valves
IBD1K04-- IBD™ 1K System with 4 Outlet Valves
IBD1K06-- IBD™ 1K System with 6 Outlet Valves
IBD1K1---- IBD™ 1K System with Temperature Control
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Products Covered
AEE33X01-1.0
IBD™ 1K Inline Buffer Dilution System User Manual Page 2 of 51
2.1. Specifications
Item Parameter
Operating System flow rate range
Dilution range
Accuracy
Line size
Maximum Operating Pressure
Inlets
Outlets
Process connection
MOC, diluent & dilute buffer zone
MOC, concentrate zone
MOC, elastomers
CIP capable
SIP capable
Temperature range
Control Method
Utility requirements
Electrical protection
Dimensions
Operator interface
Automation
OPC compliance
Software compliance
Documentation
Certificates
Qualification Package
60 to 1000 L/h
Up to 20 X (see Table 1)
±2% FS
(±1% when properly tuned)
3/4 in. (WFI inlet), 1/2 in. (buffer 1 inlet),
1/2 in. (buffer 2 inlet), 3/4 in. (main skid)
3 barg
1 x 3 x 3 (WFI pump, buffer1 pump,
Buffer 2 pump)
Configuration above, pressure relief
Tri-clamp®
316 L SS / 0.5 µm Ra with electropolish
PFA, PTFE, Polypropylene
EPDM, Santoprene
Yes
No
4 to 40 °C
Conductivity & pH feedback control;
alternatively flow control
5.5 barg instrument air,
120 VAC 1-ph 60 Hz + 460 VAC 3-ph 60 Hz
NEMA 4X, IP55
660 mm (26 in.) W x 1219 mm (48 in.) D
X 1600 mm (63 in.) H
Local touchscreen display
Siemens with historical data capability
Yes
21CFR Part 11 compliance
One electronic copy provided
Certificates of Compliance,
material certificates
Asahi IQ/OQ package available
CE Declaration of conformity available
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Important User Information
AEE33X01-1.0
IBD™ 1K Inline Buffer Dilution System User Manual Page 3 of 51
3. Important User Information
Read this before using the IBD 1K System. All users must read the entire IBD 1K System
User Manual before installing, using, calibrating or maintaining the instrument. Always keep
the User Manual at hand when using the IBD 1K System. Do not operate the IBD 1K System
in any other way than is described in the user documentation. If you do so, you may be
exposed to hazards that can lead to personal injury, and you may cause damage to the
equipment.
3.1. Intended Use
The IBD 1K System is designed for low pressure blending of buffer concentrates with
optional pH adjustment in non-GMP-regulated environments.
The IBD 1K System is not suitable for operation in potentially explosive atmosphere or for
handling flammable liquids. If the IBD 1K System is used for purposes other than those
specified in the user documentation, safe operation and the protection(s) provided by the
system may be impaired.
3.2. Regulatory Information
This section describes the directives and standards that are fulfilled by the IBD 1K System.
3.2.1. Manufacturer Information
Name of manufacturer: Asahi Kasei Bioprocess America, Inc.
Address of manufacturer: 1855 Elmdale Avenue, Glenview, IL 60026 USA
3.2.2. International Standards
The IBD 1K System complies with the standards listed in Table 3-1.
Table 3-1. Standards with which the IBD 1K System complies
Standard Description Notes
ASME BPVC VII, div1 Boiler and Pressure Vessel Code
(BPVC)
Applies only to stainless steel
components.
ASME BPE Bioprocessing equipment Applies to all components with
the exception of the integrate
configuration of the mixer rotor
(3A compliant) and the
measuring tube of the E&H
Mass Flow Meter (3A
compliant)
UL 508a
UL standard for Safety for Industrial
Control Panels
EMEA/401/01,CPMP
Note
All wetted polymer and elastomeric
parts are animal origin-free or comply
with the conditions in the standard, and
are also classified according to USP
Class VI, 21 CFR Part 177
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Getting Started
AEE33X01-1.0
IBD™ 1K Inline Buffer Dilution System User Manual Page 4 of 51
3.3. Safety Notices
This user documentation contains WARNINGS, CAUTIONS and NOTICES concerning the
safe use of the product. See explanations below.
WARNING
Warning indicates a hazardous situation which, if not avoided, could
result in death or serious injury. It is important not to proceed until all
stated conditions are met and clearly understood.
CAUTION Caution indicates a hazardous situation which, if not avoided, could
result in minor or moderate injury. It is important not to proceed until all
stated conditions are met and clearly understood.
NOTICE Notice indicates instructions that must be followed to avoid damage to
the product or other equipment.
3.4. Guide to User Manual Conventions
Note: Notes provide information for trouble-free and optimal use of the product.
Tip: Tips give information that can improve or optimize your procedures.
3.4.1. Typographical conventions
Hardware items are identified in the text by bold text (e.g., power switch).
4. Getting Started
Before installing, operating or maintaining the IBD 1K System, be aware of the hazards
described in this User Manual. Follow the instructions provided to avoid personal injury or
damage to the equipment. The warnings and cautions in the user documentation shall in no
way take precedence over more restrictive local regulations and policies. For your personal
safety it is important that you have a proper knowledge of the entire system of which the IBD
1K System is part. Study any complementary safety instructions and use appropriate personal
protection equipment for the specific application and operation environment.
4.1. Risk Assessment
The IBD 1K System has been designed and manufactured to provide a high level of personal
safety. However, the residual risk is highly dependent on the application and environment in
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