SHZ32-400 Stainless Steel Tower-Type Double Distillation Water Still

Overview

The SHZ32-400 Stainless Steel Tower-Type Double Distillation Water Still is an industrial-grade, continuous-duty purification system engineered for the reliable production of high-purity Water for Injection (WFI)-equivalent distilled water in pharmaceutical, biotechnology, clinical diagnostics, and advanced research laboratories. Operating on the principle of two-stage vapor-phase separation—first distillation followed by secondary re-vaporization and condensation—the unit eliminates non-volatile impurities, endotoxins, pyrogens, ions, and organic contaminants far beyond the capability of single-stage systems. Its tower-type vertical configuration optimizes thermal efficiency and spatial footprint while enabling stable, laminar steam flow through a precisely engineered stainless steel boiler and fractionation column. Designed for uninterrupted operation under regulated environments, the SHZ32-400 delivers consistent 400 L/h output when supplied with pre-purified feed water (e.g., primary distilled or deionized water at ≥1 MΩ·cm resistivity), meeting stringent pharmacopeial benchmarks for conductivity (<1.3 µS/cm at 25°C), total oxidizable carbon (TOC < 500 ppb), and bacterial endotoxin levels (<0.25 EU/mL).

Key Features

• Fully welded AISI 304 stainless steel construction—including boiler chamber, distillation column, condenser housing, and collection vessel—ensuring long-term resistance to chloride-induced stress corrosion cracking and alkaline/acidic cleaning agents.
• Spiral-path electric heating system with PID-controlled thermal regulation, minimizing localized overheating and scale formation while maintaining uniform steam generation across the full operational load range.
• Vertical straight-tube condenser with high-surface-area copper-alloy cooling coils and integrated recirculating coolant jacket, enabling rapid phase transition and minimizing carryover of volatile organics.
• Integrated steam separation baffle and demister pad within the distillation column to suppress entrainment and ensure optimal separation efficiency between vapor and liquid phases.
• Modular design facilitates in-situ maintenance: removable condenser assembly, accessible boiler inspection port, and tool-free drain valve for periodic descaling and validation sampling.
• Compliance-ready instrumentation interface: optional RS-485 Modbus RTU port for integration into centralized laboratory monitoring systems (LIMS) or facility SCADA networks.

Sample Compatibility & Compliance

The SHZ32-400 accepts feed water meeting ASTM D1193 Type II or ISO 3696 Class 2 specifications. It is validated for use with pretreated municipal, reverse-osmosis, or single-distilled water sources. Output water conforms to the Chinese Pharmacopoeia (2000 Edition) monograph for “Water for Injection”, including limits for nitrates, heavy metals, pH (5.0–7.0), and residue on evaporation (≤1.0 mg/100 mL). While not certified to USP or EP 2.6.1 as a standalone WFI generator, its performance profile supports qualification per FDA guidance for ancillary purified water systems used in non-sterile API synthesis, glassware rinsing, and reagent preparation. The unit’s material certification package (EN 10204 3.1) and weld traceability logs are provided for GMP audit readiness.

Software & Data Management

The SHZ32-400 operates via a front-panel digital controller with real-time display of boiler temperature (range: 0–120°C), operating pressure (vacuum-assisted mode optional), and cumulative runtime hours. Optional data logging module records timestamped temperature and power consumption at 1-minute intervals, exporting CSV files via USB for review under 21 CFR Part 11-compliant electronic record protocols. All critical parameters are configurable with password-protected access levels (Operator / Technician / Administrator), supporting ALCOA+ principles for data integrity in GLP and ISO/IEC 17025 environments.

Applications

• Production of Water for Injection (WFI)-grade water for pharmaceutical formulation, buffer preparation, and final rinse of sterile containers.
• Supply of ultra-pure water for HPLC mobile phase preparation, ICP-MS calibration standards, and cell culture media formulation.
• Continuous feed source for central lab water distribution loops serving multiple analytical workstations.
• Validation reference system in QC labs performing pharmacopeial water testing (e.g., conductivity, TOC, microbial enumeration).
• Research applications requiring low-background water for trace metal analysis, radiochemical synthesis, and nanoparticle dispersion stability studies.

FAQ

What feed water quality is required to achieve pharmacopeial compliance?
Primary distilled or deionized water with resistivity ≥1 MΩ·cm and TOC < 500 ppb is recommended. Reverse osmosis water alone is insufficient due to residual volatile organics and silica.
Can the SHZ32-400 be validated per IQ/OQ/PQ protocols?
Yes—documentation templates for Installation Qualification (IQ) and Operational Qualification (OQ) are included. Performance Qualification (PQ) requires user-defined sampling plans aligned with local regulatory expectations (e.g., USP , ChP Appendix XIX N).
Is the unit suitable for cleanroom installation?
The fully sealed, drip-free condenser and zero-oil vacuum option (if equipped) meet ISO 14644-1 Class 7 environmental requirements; external cooling water must be supplied via point-of-use heat exchanger to prevent condensate backflow.
What maintenance intervals are recommended?
Daily visual inspection; monthly descaling using citric acid solution; annual verification of temperature sensor calibration and pressure relief valve function per manufacturer’s SOP.
Does the system support automated shutdown on low-water-level detection?
Yes—dual redundant level sensors in the boiler and feed reservoir trigger immediate power cutoff and audible alarm to prevent dry-heating damage.