Chu Ding Technology LDZH-200KBS Manual-Handle Automatic Vertical Steam Sterilizer (200 L)

Overview

The Chu Ding Technology LDZH-200KBS is a vertically oriented, fully stainless steel, manually operated yet microprocessor-controlled steam sterilizer designed for high-capacity, repeatable terminal sterilization in laboratory, academic, pharmaceutical, and biomedical settings. It operates on the principle of saturated steam under controlled pressure and temperature—leveraging the well-established thermodynamic lethality of moist heat to achieve microbial inactivation per internationally recognized standards including ISO 17665-1, EN 285, and USP <1211>. With a nominal chamber volume of 200 liters, this unit supports batch processing of large loads such as surgical instrument sets, culture media bottles, glassware racks, textile packs, and pre-filled containers—making it suitable for central sterile supply departments (CSSD), microbiology labs, and bioprocessing pilot facilities where throughput and regulatory traceability are critical.

Key Features

• Full 304 stainless steel construction—including sterilization chamber, outer jacket, door, and internal trays—for corrosion resistance, cleanability, and compliance with GMP-grade surface requirements.
• Manual rotary handle quick-opening door with integrated mechanical and electronic safety interlocks; prevents door opening until chamber pressure drops to ambient and temperature falls below 80 °C.
• Microprocessor-based control system with real-time LCD display showing setpoint and actual values for temperature, pressure, time, and phase status (heat-up, sterilize, exhaust, dry).
• Precise programmable parameters: sterilization temperature adjustable from 50 °C to 134 °C in 1 °C increments; exposure time configurable from 0 to 99 hours in 1-minute steps.
• Automatic cycle execution with pre-programmed or user-defined sequences—including gravity displacement, liquid, and wrapped load modes—each with configurable pre-vacuum, heating, sterilizing, exhaust, and drying phases.
• Overpressure safety relief valve calibrated to activate between 0.145 and 0.208 MPa (21–30 psi), compliant with ASME BPVC Section VIII and PED 2014/68/EU requirements.
• Acoustic end-of-cycle alert followed by automatic power cutoff and passive cooling mode to minimize operator intervention and ensure process consistency.

Sample Compatibility & Compliance

The LDZH-200KBS accommodates diverse load configurations without requiring external vacuum pumps: gravity-displacement cycles effectively remove air from porous loads (e.g., gauze, linen, autoclave bags), while extended heating profiles support thermal stabilization of liquids (e.g., agar media, saline solutions) and heat-sensitive materials via slow-cool protocols. All sterilization cycles adhere to the fundamental requirements of ISO 13485:2016 for medical device manufacturers and align with validation prerequisites outlined in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing and EU Annex 1. The unit’s material compatibility, surface finish (Ra ≤ 0.8 µm), and absence of crevices facilitate routine cleaning and meet criteria for ALCOA+ data integrity when used with optional audit-trail-enabled software modules.

Software & Data Management

While the base LDZH-200KBS operates via embedded firmware with non-volatile memory storing up to 100 cycle logs (including date/time stamp, setpoints, actual values, and fault codes), optional RS-485/USB interfaces enable integration with laboratory information management systems (LIMS) or supervisory control and data acquisition (SCADA) platforms. When paired with validated PC-based software, the system supports 21 CFR Part 11-compliant electronic records—including user authentication, electronic signatures, and immutable audit trails—required for GLP, GCP, and GMP environments. Cycle reports export in CSV or PDF format for quality review, deviation investigation, and regulatory submission.

Applications

• Sterilization of reusable surgical instruments and dental handpieces in teaching hospitals and outpatient clinics.
• Preparation and sterilization of microbiological growth media (e.g., nutrient agar, Sabouraud dextrose) in university research labs and QC testing facilities.
• Decontamination of biohazardous waste and contaminated labware prior to disposal in BSL-2 and BSL-3 containment laboratories.
• Processing of glass vials, Petri dishes, pipette tips, and stainless-steel containers used in cell culture and molecular biology workflows.
• Validation support for sterilization process development, including D-value and F₀ calculations using logged temperature-pressure-time profiles.

FAQ

What sterilization standards does the LDZH-200KBS comply with?
It meets the essential safety and performance requirements of ISO 17665-1:2017, EN 285:2015, and GB 8599–2008 (Chinese national standard for large steam sterilizers). Validation documentation supports alignment with FDA and EMA expectations for routine use in regulated environments.
Can the unit be validated for IQ/OQ/PQ protocols?
Yes—the consistent thermal distribution, pressure stability, and digital logging capability enable full installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) per ISO 13485 and ISO 14971 risk management frameworks.
Is a printer or external data logger included?
No—these are optional accessories. The unit provides analog and digital output ports compatible with third-party chart recorders and certified data loggers meeting IEC 60751 Class A tolerance.
Does it support vacuum-assisted air removal?
No—the LDZH-200KBS uses gravity displacement only. For vacuum-assisted cycles (e.g., for wrapped or porous loads), consider the LDZK-V series equipped with integrated vacuum pumps.
What maintenance intervals are recommended?
Daily: chamber inspection, door gasket cleaning, drain line flush. Quarterly: safety valve calibration verification, door interlock functional test. Annually: full thermocouple and pressure transducer calibration by an accredited service provider.