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Sterilization Equipment

Sterilization Equipment Catalog 


Steam sterilization equipment is designed for the decontamination of instruments, consumables, textiles, and liquids in medical and laboratory facilities. The INEX catalog features vertical steam sterilizers (autoclaves) and pass-through models with a barrier construction, ensuring the highest level of safety and compliance with sanitary standards. The equipment is engineered for intensive operation and is available in various volumes and configurations.

Areas of Application

Sterilization equipment is utilized across a broad spectrum of institutions requiring reliable decontamination:

  • Medical Facilities: Central Sterile Services Departments (CSSD), surgical units, maternity wards, and dental clinics.

  • Laboratories: Facilities with biosafety levels BSL-2/3/4 use sterilizers for processing glassware, instruments, and waste.

  • Pharmaceutical & Biotech: Sterilization of packaging materials, finished dosage forms, and production line components.

  • Medical Device Manufacturing: Ensuring product sterility prior to final packaging.

  • Research & Veterinary: Decontamination of instrumentation and materials in research institutes and vivariums.

Design and Technical Specifications

Equipment supplied by INEX is characterized by industrial reliability, automated control, compliance with GOST requirements, and multi-level safety systems.

  • Chamber Construction: Made of AISI 304 or AISI 316L stainless steel with a mirror-polished internal surface to prevent corrosion and facilitate cleaning.

  • Operating Parameters: Working pressure up to 2.5 atm; temperature range from 121°C to 134°C with a precision of $\pm 1°C$.

  • Control System: Microprocessor-based with a touch panel or LED display. Includes pre-installed programs for instruments, textiles, liquids, and glassware, as well as customizable user cycles.

  • Safety Features: Protection against overheating, dry running, and overpressure. The chamber features automatic door locking to prevent opening under pressure and specialized seals for hermetic integrity.

  • Automation: Features include automatic water filling, condensate drainage, steam purging for air removal, and a built-in drying function for ready-to-use materials.

Regulatory Requirements and Standards

The equipment complies with key Russian and international standards:

  • GOST R 58104.1-2018: Requirements for construction and testing of medical steam sterilizers.

  • GOST ISO 17665-1-2013: Validation and routine control of moist heat sterilization.

  • GOST R ISO 14937-2011: General requirements for sterilization agent characterization.

  • EN 285 & ISO 11134: European and international standards for large and small sterilizers.

  • US FDA 21 CFR Part 11: Compliance for digital data recording and electronic signatures.

  • SanPiN 3.3686-21: Sanitary and epidemiological requirements for sterilization measures.

Each unit is supplied with a comprehensive documentation package, including the product passport, operation manual, certificate of conformity, and factory test protocols.

Safety and Validation

The validation system includes a full set of documents for qualification testing:

  • Installation Qualification (IQ): Confirms correct mounting and connection.

  • Operational Qualification (OQ): Verifies equipment performance within specified parameters.

  • Performance Qualification (PQ): Confirms sterilization efficiency in real-world conditions.

The system features real-time logging of cycle parameters to non-volatile memory. Data can be exported for archiving and analysis. Remote monitoring is available via RS-485, Ethernet, or wireless modules, allowing for integration with SCADA or Hospital Information Systems (HIS).