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IBD™ In-line Buffer Dilution Systems
Prepare and Dilute Buffers with Adaptive PAT™ Blend Control
Realize the significant cost and regulatory benefits of lean manufacturing
and PAT (Process Analytical Technology)
- Modular solution for the preparation of dilute buffers from concentrates
- Create just-in-time buffers for downstream processing steps, cell culture, or formulation
- Achieved significant floor space savings by eliminating legacy approach of large storage tanks of dilute buffers
- Prepare hundreds or thousands of liters of dilute buffer on demand
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IBD™ Systems
(Integrated or Stand-alone)
- Generate significant positive cash flow
- Utilize disposable bag technology to hold concentrates and dilute on demand
- Increase buffer capacity by maximizing usage of existing tanks
- Reduce maintenance and cleaning validation costs associated with large tanks
- Reduce risk of out-of-specification buffers that can occur with legacy approach
- Best in class buffer dilution accuracy using Adaptive PAT™ technology compensates for variability in the buffer concentrate – deliver precise and reproducible buffers to within 1 mS of setpoint or less
- pH adjust your dilute buffers with the pH adjustment add-on module to within +/- 0.1 pH units
- Integrate IBD™ systems within existing facilities to provide point of use adjustment and precise control of dilute buffers
- IBD™ systems are ASME BPE 2005 compliant
- Standard IBD™ Systems are available at capacities up to 1200 L/hr.
- Engineered IBD™ and Stand-alone Buffer Systems are built to order and available from pilot scale to full process scale (from 60-6,000 L/hr or higher).
- Available with Allen-Bradley PLC control with integrated OIT or external PC
- 21CFR Part 11 capable
- Connect into plant wide control system
- Real time data logging of conductivity, pH, temperature, volume
- Complete IQ/OQ and GAMP-4 execution and documentation available for turnkey operation
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Select from a range of available process values
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Intuitive method creation
GAMP-4 Validation Available
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Configurable alarm settings
3D CAD modeling
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Comprehensive IQ/OQ Validation Documentation
Best in the industry, well-organized and comprehensive
TechniKrom designs, builds and tests all equipment in accordance with FDA, ISPE GAMP-4, ASME-BPE, UL,
and international codes (e.g. ATEX). A project engineering manager coordinates each project and works
with you directly, from the design phase to the final installation and training.
Comprehensive IQ/OQ validation package includes TechniKrom's world-class validation
protocol and system documentation. The validation package provides detailed testing
reports on all IQ/OQ validation procedures (over 200 tests) as well as all component
manuals, test certificates and documentation. Our clients have been able to cut validation
times from months to days using our validation package.
Warranty and Technical Support
- One year extendable warranty, service contracts and 24 hour response time means peace of mind and fast support when you need it.
- Our partner companies throughout Europe and Asia assist with overseas tech support Additional Biopharmaceutical Products:
- Chromatography skids with Adaptive PAT™
- IBD™ in-line buffer dilution skids with Adaptive PAT™
- Adaptive PAT™ pH adjustment skids
- Dynamic axial compression bioprocess columns
- Dynamic axial Compression HPLC columns
- AGPTS gold particle post-use integrity test systems for Asahi Planova™ virus removal filters
- TFF skids as well as VF skids to support Asahi Planova™ virus removal filters
About TechniKrom
TechniKrom is a privately held, diversified engineering and qualification firm that provides
technologically advanced blending, synthesis, filtration and purification equipment,
products and services to the Biopharmaceutical, Pharmaceutical, and Nutraceutical
Industries worldwide that permit the lowest cost of production and highest innate
product quality, especially in cGMP regulated environments. TechniKrom promotes the
implementation of Manufacturing Science in biopharmaceutical manufacturing facilities.
For additional information, visit www.technikrom.com. |
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