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Highly purified, low-extractables matrix specifically engineered for ultra-high-purity water production in critical pharmaceutical and biotech processes.
Uniform spherical bead morphology ensures consistent hydraulic performance, low pressure drop, and superior regeneration efficiency.
Exceptionally low total organic carbon (TOC) release and minimal metal leaching—validated per USP <841> and EP 2.2.43 requirements.
Optimized for mixed-bed configurations with strict stoichiometric balance between strong acid cation (SAC) and strong base anion (SBA) resins.
Pre-compacted and pre-rinsed to reduce commissioning time and eliminate initial rinse cycles in GMP-compliant facilities.
Final polishing of Water for Injection (WFI) and Purified Water (PW) systems in pharmaceutical manufacturing.
Ultrapure water generation for biologics purification, cell culture media preparation, and sterile filtration support.
Critical feedwater treatment for steam generators in clean-steam applications compliant with ISO 13485 and FDA 21 CFR Part 211.
High-recovery demineralization in semiconductor-grade ultrapure water (UPW) pretreatment loops requiring sub-ppt ionic contamination control.
Regulatory-compliant polishing in single-use bioprocessing skids and modular water systems.
| Chemical Type | Strong Acid Cation / Strong Base Anion Mixed Bed (SAC/SBA) |
| Product Form | Pre-mixed, pre-compacted, ready-to-use wet resin blend |
| Appearance | Uniform amber (cation) and white (anion) spherical beads in aqueous suspension |
| Primary Applications | Pharmaceutical WFI/PW polishing, biotech UPW, clean-steam generation |
| Key Features | Low TOC release, minimal metal leaching, GMP-compatible packaging |
| Storage Conditions | 5–35 °C; protect from freezing and direct sunlight |
| Regeneration Requirement | Not regenerable on-site; designed for single-use or limited-cycle validated operation |
| Compliance | USP <841>, EP 2.2.43, ISO 13485, FDA 21 CFR Part 211 (supporting documentation available) |
Q1: What is the primary application of Lanxes-s LEWATIT UltraPure 1261 MD?
A: This resin is specifically engineered for ultra-purification of high-value process streams in pharmaceutical, biotechnology, and fine chemical manufacturing—particularly where removal of trace ionic impurities, metal ions, or low-molecular-weight charged contaminants is critical prior to final formulation or filling.
Q2: How does UltraPure 1261 MD differ from standard Lewatit cation exchange resins?
A: UltraPure 1261 MD features an ultra-low extractables profile, enhanced chemical stability under stringent sanitization conditions (e.g., hot water or steam), and tightly controlled particle size distribution optimized for low-pressure-drop operation in polishing applications—making it suitable for GMP-aligned processes where resin leachables must be minimized.
Q3: Can this resin be used in continuous chromatography systems?
A: Yes—UltraPure 1261 MD is designed for compatibility with modern continuous ion exchange and multi-column chromatography platforms, offering consistent hydraulic performance and mechanical robustness over extended cyclic operation when operated within recommended flow and pressure parameters.
Q4: What regeneration protocols are recommended?
A: Regeneration typically employs dilute mineral acid (e.g., hydrochloric or sulfuric acid) for cation exchange mode, followed by thorough deionized water rinsing. Specific protocols should be validated per process requirements, considering feed composition, throughput, and purity targets—especially in regulated environments.
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E-mail: wangxingqiang@ericwchem.com
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Building A1, Jiete Industrial Park, Huangpu District, Guangzhou City, Guangdong Province, China
