Shanghai Huaxi SHZ32-200 / SHZ32-100 / SHZ32-50 Stainless Steel Tower-Type Double-Distillation Water Still

Overview

The Shanghai Huaxi SHZ32 Series represents a line of industrial-grade, tower-type double-distillation water stills engineered for continuous production of high-purity water in regulated laboratory and pharmaceutical environments. Unlike single-stage vapor compression or reverse osmosis systems, the SHZ32 employs a true two-pass thermal distillation process: feed water is first vaporized in a stainless steel boiler chamber, then condensed; the resulting primary distillate undergoes a second controlled vaporization and condensation cycle within an integrated vertical tower column. This dual-stage thermal separation effectively removes non-volatile ions, organic contaminants, endotoxins, and pyrogens—achieving conductivity values typically below 1.0 µS/cm at 25 °C and total oxidizable carbon (TOC) levels consistent with Water for Injection (WFI) requirements per Chinese Pharmacopoeia (2000 Edition). The unit operates under atmospheric pressure with no moving parts in the distillation path, ensuring mechanical reliability and minimal maintenance over extended service life.

Key Features

• AISI 304 stainless steel construction throughout—boiler, evaporator, condenser, collection vessel, and structural frame—providing long-term resistance to chloride-induced stress corrosion cracking and alkaline degradation.
• Spiral-coil electric heating system optimized for uniform thermal distribution and rapid boiler warm-up, minimizing localized scaling and extending element service intervals.
• Vertical inline condenser with high-surface-area copper tubing and forced-air cooling design, enabling efficient phase transition without reliance on external chilled water circuits.
• Tower-column geometry facilitates gravitational reflux and vapor–liquid equilibrium control, enhancing separation efficiency for volatile impurities such as ammonia, formaldehyde, and low-molecular-weight organics.
• Integrated steam extraction manifold positioned at the optimal vapor saturation zone ensures consistent feed to the secondary distillation stage, maintaining reproducible purity across variable load conditions.
• Front-access service panel with standardized electrical terminals, drain valves, and level indicators simplifies routine inspection, descaling, and preventive maintenance in GLP-compliant facilities.

Sample Compatibility & Compliance

The SHZ32 series accepts municipal tap water, deionized water, or softened feed water with total dissolved solids (TDS) ≤ 500 ppm and free chlorine ≤ 0.5 ppm. It is validated for use in environments requiring compliance with Chinese Pharmacopoeia (ChP) 2000 Edition standards for Water for Injection (WFI), including sterility testing labs, quality control units in API manufacturing, and preclinical research facilities. While not certified to USP or EU Ph. Eur. 2.2.46 out-of-the-box, its material traceability (304 SS mill test reports), absence of elastomeric wetted parts, and documented thermal validation protocols support IQ/OQ qualification under FDA 21 CFR Part 11 and Annex 11 frameworks when paired with appropriate calibration and audit trail documentation.

Software & Data Management

The SHZ32 operates as a standalone analog-controlled system with no embedded microprocessor or digital interface. Temperature monitoring is performed via calibrated bimetallic thermometers (±1.5 °C accuracy), and water level is indicated by sight glass with float mechanism. For regulatory environments requiring electronic data integrity, third-party PLC integration kits are available—including 4–20 mA temperature and level signal outputs, relay-based alarm dry contacts, and optional RS-485 Modbus RTU modules compatible with SCADA or LIMS platforms. All operational logs (start/stop timestamps, manual descaling records, conductivity verification results) must be maintained manually in accordance with ALCOA+ principles for GMP audibility.

Applications

• Production of Water for Injection (WFI) in small-to-medium scale pharmaceutical laboratories conducting dissolution testing, buffer preparation, and HPLC mobile phase formulation.
• Continuous supply of ultra-pure water for cell culture media preparation, where endotoxin levels < 0.25 EU/mL and silica content < 10 ppb are critical.
• Supporting ASTM D1193 Type I water specifications for analytical chemistry applications including ICP-MS sample introduction, trace metal analysis, and standard solution dilution.
• On-site generation of compliant water in regional QC labs lacking access to centralized purified water systems, reducing dependency on bottled WFI and associated contamination risks during transport and storage.
• Teaching laboratories requiring demonstrable thermal separation principles, including latent heat transfer, vapor pressure differentials, and fractional purification kinetics.

FAQ

What feed water quality is required to achieve pharmacopeial compliance?
Feed water should exhibit TDS ≤ 500 ppm, hardness ≤ 100 ppm CaCO₃, and free chlorine ≤ 0.5 ppm. Pre-filtration through 5-µm sediment and activated carbon cartridges is strongly recommended to prevent fouling of the boiler and condenser surfaces.
Can the SHZ32-200 be validated for GMP use?
Yes—when installed with documented IQ/OQ protocols, calibrated instrumentation, and periodic performance qualification (PQ) using conductivity, TOC, and endotoxin testing per ChP 2000, it supports GMP water system validation in non-sterile manufacturing settings.
Is the unit suitable for installation in cleanrooms?
The SHZ32-200’s footprint (920 × 920 mm) and height (1300 mm) require dedicated utility space outside ISO Class 5–8 environments; however, its polished 304 SS finish and zero-oil operation make it compatible with adjacent technical corridors serving cleanroom suites.
How often does descaling need to be performed?
Under typical municipal feed water conditions, descaling with citric acid solution is required every 200–300 operating hours; frequency increases proportionally with feed water hardness and TDS concentration.
Does the system include automatic shut-off on low water level?
Yes—a mechanical float switch interrupts power to the heating elements when boiler water level falls below the safe operational threshold, preventing dry-firing and thermal damage.