www.technikrom.com

IBD™ In-line Buffer Dilution Systems

De-Bottleneck Your Facility

:: Engineered solutions to provide lowest total cost of ownership

:: Create just-in-time buffers for downstream processing steps

:: Prepare tens of thousands of liters of buffer per hour in a footprint of

World class processing equipment and services for biopharm, pharma and nutraceutical industries

IBD™ Systems:: Increase buffer capacity without buildouts and debottleneck your

downstream processing steps

:: Use up to 10X buffer concentrates to achieve significant floor space savings

:: Decouple the accuracy of your 1X buffer from the accuracy of theconcentrate

:: Use for buffer-intensive chromatography, filtration, cell culture andformulation steps

:: Improve recovery and yield with run-to-run reproducibility of buffercomposition

:: Utilize single-usedisposable bagtechnology to holdconcentrates and diluteon demand

:: Increase buffer capacityby maximizing usage ofexisting tanks

:: Reduce maintenanceand cleaning validation costs associated with large tanks

:: Reduce risk of out-of-specification buffers that can occur with legacy approach

:: pH adjust your dilute buffers with the pH adjustment add-on module

:: Dilute your buffers using patented Adaptive PAT™ feedback controltechnology or via mass flow control

:: Blend buffers with organic solvents such as alcohols or ACN using theorganic blending option

:: Pump-based or control valve-based options available

:: Integrate IBD™ systems within existing facilities to provide point of useadjustment and precise control of dilute buffers

:: Experience the regulatory benefit of PAT implementation

:: Realize highest return on investment

:: Includes an industrial platform to provide highest uptime

:: Scale-up seamlessly from pilot to commercial scale

:: Sanitary and ASME-BPE compliant; drainable options available

:: Built-in CIP software module to automate skid cleaning

:: Dual-line systems available to permit the dilutions of two different buffers simultaneously in parallel

3D CAD modeling

800-865-4100 ˚ International phone 847-556-9700Technikrom Inc. ˚ 1855 Elmdale Ave. ˚ Glenview, IL 60026 ˚ www.technikrom.com ˚ tkr.sales@technikrom.com

:: Electropolished 316L SS and PTFE parts are compatible with typical mobile phases. Other materials of construction such as fully polymeric, Hastelloy and AL6XN also available

:: Temperature-compensated conductivity and pHmeasurement

:: Temperature control options available

:: Monitoring with conductivity, pH, temperature,pressure and flow measurement

:: All wetted parts are fully traceable and serialized

:: 100% boroscopic inspection available

:: Hazardous area ratings in compliance with UL andATEX are available

:: Engineered IBD™ systems at a wide range of flowrates up to 250 L/min or higher

:: Custom designs to fit through doorways or into tightpurification suites

:: Worldwide install base throughout US, Europe, and Asia

:: CE Pressure Equipment Directive compliance available

:: USP Class VI and non-animal-derived gasket options available

Verfies

Verfies

Verfies

User RequirementSpecification

(URS)

Process Qualification

(PQ)

OperationalQualification

(OQ)

InstallationQualification

(IQ)

FunctionalRequirementSpecifications

(FRS)

DesignSpecifications

(HDS/SDS)

System Build

GAMP-5 Validation Available

Net Present Value/ Return on Investment:: The TechniKrom IBD™ system has been specifically designed in alignment with TechniKrom’s core mission:

to drive down the costs of manufacturing biopharmaceuticals while providing the highest innate quality ofbuffer product

:: Reduce operating costs and generate significant positive cast flow

:: Contact your local sales representative to determine the NPV/ROI ofthe IBD™ system for your particular application

Cumulative Cash FlowCumulative Discounted Cash Flow

20,000,000

15,000,000

10,000,000

5,000,000

0

0 2 4 6 8 10 12-5,000,000

Year

Cu

mu

lati

ve $

Dol

lars

Cumulative Cash Flows

IBD™ enhances batch-to-batch buffer reproducibility to dramatically improve therecovery of your high-value product and promote stable manufacturing processes

Select from a range ofavailable process values

Validated Automation Packages:: Available with Allen-Bradley PLC control, or integrate

into your plant-wide control system (DeltaV, Allen-Bradley, ABB)

:: Integrate with existing chromatography and filtration skids

:: 21CFR Part 11 capable and GAMP-5 compliant ProcessControl software

:: Full audit trail and electronic signature

:: Buffer recipe methods set up in minutes using intuitivemethod editor software

:: Method steps can be imported, exported and copied tosimplify programming

:: Regulate your process by flow rateset point or pressure set point

:: Real time data logging ofconductivity, pH, pressure, flow,temperature

:: Multi-level alarming

:: Batch reports can be customized by user

:: Complete IQ/OQ execution anddocumentation available for turnkey operation

Configurable alarm settings

Intuitive method creation

Model # Flow Specification Dilution Range

IBD300 100-300 L/hr 5X-10X or 1X-5X

IBD500 100-500 L/hr 5X-10X or 1X-5X

IBD1200 120-1200 L/hr 5X-10X or 1X-5X

IBD2000 500-2000 L/hr 5X-10X or 1X-5X

IBD5000 1200-5000 L/hr 5X-10X or 1X-5X

IBD10000 3000-10,000 L/hr 5X-10X or 1X-5X

IBD15000 5000-15,000 L/hr 5X-10X or 1X-5X

Typical IBD™ Systems

:: Options include- Dilution range- Local or remote HMI- Inline pH adjustment

module- Organic solvent

blending capability- Multiport

concentrate inletmanifold

- Blending loop withbypass and

additional conductivity (spanned for LO range)

- Flowmeter options- Hazardous area rating- WFI break tank- Dilute buffer surge tank- Polymeric or stainless steel MOC

:: Engineered systems at differentflow rates are available

IBD300300 L/hr standard Inline Buffer Dilution IBD™ systems now available with thefollowing technical specifications:

:: 300 L/hr max flow rate ideal for pilot scale applications, low volumeproduction, and trial runs

:: Polymeric product contact parts for corrosion resistance

:: 5X to 10X dilutions possible via patented AdaptivePAT™ feedback control

:: Dimensions: 48” W x 40” D x 76” H

:: Standard configuration includes the followingoptions:- Local Integrated Display HMI- Inline pH adjustment module- 4-port concentrate inlet manifold- Blending loop with bypass

:: Utilities: 230V single phase power and 6 barginstrument grade air

:: Fast delivery – typically available within 8weeks or less

IBD300

Warranty and Technical Support:: One year extendable warranty, service contracts and 24

hour response time means peace of mind and fast supportwhen you need it

:: Partner companies throughout Europe and Asia assist withoverseas tech support

Other TechniKrom Products andServices for the Bio, TIDES, and Pharma Industries::: Dynamic Axial Compression Bioprocess LC Columns

:: Bioprocess LC Systems

:: TechniPur™ chromatography packing materials

:: Process development, scale-up and tech transfer support

:: Equipment Validation services (IQ/OQ and GAMP-5)

:: Service Contracts

TechniKrom, Inc.1855 Elmdale Ave.

Glenview, IL 60026 U.S.A.800-865-4100

800-293-5059 (fax)+1 847-556-9700 (int’l)

+1 847-556-9701 (int’l fax)www.technikrom.com

tkr.sales@technikrom.com

About TechniKromTechniKrom is a privately held, diversified engineering and qualification firmthat provides technologically advanced blending, synthesis, filtration andpurification equipment, products and services to the Biopharmaceutical,Pharmaceutical, and Nutraceutical Industries worldwide that permit thelowest cost of production and highest innate product quality, especially incGMP regulated environments. TechniKrom promotes the implementation of Manufacturing Science in biopharmaceutical manufacturing facilities. For additional information, please visit www.technikrom.com.

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