Heineu LS-60SV Vertical Pulsed Vacuum Sterilizer

Overview

The Heineu LS-60SV Vertical Pulsed Vacuum Sterilizer is a Class B steam sterilization system engineered for high-reliability terminal sterilization of heat-stable medical devices, laboratory glassware, culture media, surgical instruments, and porous loads in compliance with international standards including ISO 17665-1, EN 285, and relevant clauses of FDA 21 CFR Part 820. It employs saturated steam under controlled pressure and temperature, combined with a multi-pulse vacuum cycle to remove air from load chambers—ensuring complete steam penetration into lumens, wrapped packs, and absorbent materials. Unlike gravity-displacement sterilizers, the LS-60SV achieves sterilization efficacy through validated vacuum-assisted air removal (down to –0.080 MPa), followed by steam injection, dwell, and vacuum drying phases—all executed within a single integrated cycle. Its vertical configuration optimizes floor space usage while supporting ergonomic loading/unloading via a motorized lift-and-lower door mechanism.

Key Features

• Vertical lift-door design with motorized actuation: Reduces operator physical strain and improves access to full chamber depth during loading and unloading.
• Pulsed vacuum pre-conditioning: Up to three programmable vacuum pulses prior to sterilization ensure >99.9% air removal from complex or nested loads, meeting EN 285 requirements for Class B cycle validation.
• Integrated electric steam generator (3 kW): Eliminates dependency on external boiler infrastructure; enables rapid, on-demand steam generation with precise pressure control and reduced thermal stress on sensitive items.
• Full-cycle automation: One-touch execution of water intake, pulsed vacuum, heating, sterilization hold, condensate drainage, steam exhaust, and final vacuum drying (≤10% residual moisture).
• 7-inch capacitive touchscreen HMI: Supports user-defined cycle programming, real-time parameter monitoring, event logging, and password-protected access levels for operator, supervisor, and service roles.
• Onboard PT/TT test ports: Compliant with ISO 17665-1 Annex C for routine biological and physical challenge testing using thermocouples and process challenge devices (PCDs).
• Sartorius midisart® 2000 0.20 µm hydrophobic filter: Installed on the vacuum vent line to maintain sterile integrity during air re-entry, preventing microbial ingress during drying and cooling phases.
• Closed-loop steam/water circulation: Condensate is recirculated internally; no live steam discharge to ambient environment—reducing facility HVAC load and maintaining lab environmental hygiene.

Sample Compatibility & Compliance

The LS-60SV accommodates a broad range of sterilizable materials, including stainless-steel surgical kits, textile packs, rubber tubing, plastic petri dishes, agar-based microbiological media (in sealed containers), and glass vials. Its 60 L chamber volume supports standard instrument trays (up to 300 × 200 × 100 mm) and stacked media bottles. The system complies with ISO 11134 for validation of moist heat sterilization processes and supports installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) documentation frameworks aligned with GLP and GMP environments. All firmware logs—including cycle start/stop timestamps, temperature/pressure profiles, vacuum depth, and alarm events—are timestamped and non-erasable, satisfying audit requirements under FDA 21 CFR Part 11 for electronic records and signatures.

Software & Data Management

Embedded firmware provides cycle traceability through a built-in event logger that records ≥10,000 cycles with time-stamped parameters at 1-second intervals. Data export is supported via USB port in CSV format for integration with LIMS or quality management systems. Optional Ethernet connectivity (via RS485-to-Ethernet converter) enables remote monitoring and centralized fleet management. Audit trail functionality includes user login/logout events, parameter modification history, and cycle abort/restart annotations—each tagged with operator ID and timestamp. Cycle reports include integrated pass/fail assessment against preset acceptance criteria (e.g., F₀ ≥ 12, T ≥ 134 °C for ≥3 min, vacuum depth ≤ –0.080 MPa).

Applications

This sterilizer is routinely deployed in hospital central sterile supply departments (CSSD), academic research laboratories, pharmaceutical QC labs, biotech pilot facilities, and veterinary diagnostic centers. Typical use cases include terminal sterilization of reusable laparoscopic instruments, preparation of sterile cell culture consumables, decontamination of biohazard waste containers, and validation of autoclave-compatible packaging materials. Its ability to process porous and hollow-load configurations makes it suitable for sterilizing filter housings, pipette tip racks, and filtration assemblies used in aseptic processing workflows.

FAQ

What vacuum level does the LS-60SV achieve during pulsed cycles?
The system reaches a minimum vacuum of –0.080 MPa (absolute) during each pulse, verified by calibrated digital vacuum transducers traceable to NIST standards.
Is the steam generator self-contained or externally supplied?
It features an integrated 3 kW electric steam generator—no external steam line required—and includes automatic water level sensing and overheat protection.
Can the LS-60SV be validated for ISO 13485-compliant production environments?
Yes. Its architecture supports IQ/OQ/PQ protocols, includes PT/TT ports for thermocouple mapping, and generates compliant electronic records for regulatory submissions.
Does the unit meet EN 285 for large steam sterilizers?
While classified as a small-to-medium Class B sterilizer, its pulsing logic, vacuum performance, and cycle reproducibility align with EN 285 Annex A requirements for vacuum-assisted systems.
What type of maintenance is required for the Sartorius air filter?
The midisart® 2000 filter cartridge must be replaced after 500 cycles or annually—whichever occurs first—and is certified for integrity testing via bubble point or diffusion rate methods.