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Ultra-low extractables profile specifically validated for pharmaceutical and bioprocess water systems.
Highly uniform spherical beads ensuring consistent hydraulic performance and minimal pressure drop.
Optimized for mixed-bed polishing applications requiring ultrapure water (UPW) with resistivity >18.2 MΩ·cm.
Manufactured under ISO 9001-certified conditions with full traceability and lot-specific QC documentation.
Resistant to organic fouling due to highly cross-linked macroporous matrix structure.
Final polishing stage in pharmaceutical-grade purified water (PW) and water-for-injection (WFI) generation systems.
Ultrapure water production for semiconductor manufacturing rinse processes.
Biopharmaceutical downstream processing support, including buffer preparation and chromatography system regeneration.
Clean-in-place (CIP) rinse water polishing in aseptic filling facilities.
Research-grade laboratory water systems requiring TOC <1 ppb and silica <0.1 ppb.
| Chemical Type | Strong acid cation (SAC) / strong base anion (SBA) mixed bed resin |
| Product Form | Uniform spherical beads, pre-mixed 1:1 volume ratio |
| Appearance | Opaque white (cation) and translucent amber (anion) beads, visually homogeneous |
| Primary Applications | Ultrapure water polishing for pharma, biotech, and microelectronics |
| Key Features | Low sodium leakage, low TOC elution, high regeneration efficiency |
| Storage Conditions | 5–40 °C; keep container sealed and away from direct sunlight |
| Regeneration Compatibility | NaOH and HCl (standard chemical regeneration) |
| Compliance | USP <643>, EP 2.2.44, ASTM D1193 Type I, ISO 3696 Grade 1 |
Q1: What is the primary application of LEWATIT UltraPure 1297 MD in pharmaceutical and biotech processes?
A: LEWATIT UltraPure 1297 MD is specifically engineered for high-purity polishing applications in pharmaceutical water systems and buffer preparation, where removal of trace ionic contaminants—including heavy metals and residual process ions—is critical to meet stringent quality requirements.
Q2: How does the "UltraPure" designation differentiate this resin from standard LEWATIT 1297 MD grades?
A: The UltraPure designation reflects an enhanced manufacturing and packaging protocol—包括 additional low-ionic wash steps, strict particulate control, and double-bagged sterile packaging—to minimize extractables and ensure compatibility with ultra-high-purity water systems used in parenteral manufacturing and cell culture media preparation.
Q3: Is LEWATIT UltraPure 1297 MD suitable for use in single-use bioprocessing systems?
A: Yes—it is widely deployed in disposable polishing cartridges and inline ion exchange modules due to its high chemical stability, low pressure drop, and compatibility with common single-use housing materials such as polypropylene and polysulfone.
Q4: What regeneration protocols are recommended for maintaining performance over multiple cycles?
A: Regeneration typically employs dilute sodium hydroxide (NaOH) followed by thorough deionized water rinsing. Optimized protocols depend on feedwater composition and throughput, but extended cycle life is achieved through controlled flow rates and avoidance of pH extremes outside the resin’s specified operating range.
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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
