Laboratory Series Autoclaves – Sterilizers
Metalchem have established a reputation for the highest available standards of performance, uncompromised regulatory conformance and certainty of validation. These are the results of over 30 years R&D in process development and control systems.
Autoclaves designed to sterilize at temperatures between 120°C and 135°C through the use of steam. Choose from a stainless steel or nickel-clad steel vessel construction in a variety of sizes and programmable control options for pre-vacuum or gravity operation.
All Features and benefits like data storage, real time monitoring, and cycle alerts & reminders.
Depending on desired application, sterilizers can be certified for compliance to the following standards for performance and safety. Selected models qualify as a medical device by the FDA.
• ASME (American Society of Mechanical Engineers): Section VIII, Division I (Unfired Pressure Vessel) code.
• ASME: Section I Code (Power Boilers).
• IEC (International Electrotechnical Commission): EN 61010-1:96—Safety requirements for electrical equipment for measurement, control, and laboratory use. EN 61010-2-041:96—Specific requirements for steam autoclaves. • UL and cUL (Underwriters Laboratory): Standard 61010-1 and 61010-2. •
• EN ISO 111345-R-8/93— AAMI (Association for the Advancement of Medical Instrumentation) Industry Standard for Moist Heat Sterilization.
• 21 CFR Part 11 (US Code of Federal Regulations, Section 21—Food and Drugs; Electronic Records; Electronic Signatures).
• ANSI/AAMI ST-8: Hospital Steam Sterilizers.
|Automation Grade||Fully Automatic|
|Size||80ltr - 3000 ltr|
Design and Technical Features
- Chamber volume: 650 liters (FOB5-TS) - 670 liters (FOB5S-TS) - 837 liters (FOB5/L-TS) - 830 liters (FOBS5/L-TS)
- Free standing single or recessed with double doors for pass-through application;
- Vertically automatic sliding doors effortless pneumatically operated;
- Built-in, external or combined steam source;
- Massive, long-lived pressure vessels PED certified, exclusive pneumatic valves and hydraulic components made of high corrosion resistant AISI 316 L stainless steel, sanitary grade;
- Internal high-efficiency jacket by 316 L stainless steel plate heat exchanger for steam preheating/drying;
- Unique door closing system with patented pneumatic gasket seal for perfect airtight, safety and maximum reliability;
- Ergonomic loading height;
- Special execution with single or double stainless steel sealing flange (BIOSEAL) for laboratory risk category L3 and L4 and operating theater;
- Operation of the unit from both ends by operator panel and display fitted on loading and unloading sides;
- Operation of the unit from both ends
- DCS PLUS 10 process controller with large touch-screen color video-graphic display
- Fully programmability: 30 standard sterilization programs easy to customize in a multi-user environment;
- Operating software fully validated and documented to conform with the rigorous pharma standards for reproducibile processes;
- GLP compliant.
Advantages and Key Benefits
- Superior quality of materials with first class finishing and components all rigorously tested at Fedegari’s, for long term reliability and process safety;
- High-tech chamber and door system construction;
- Improved performances thanks to more efficient and faster processing;
- Short batch time and optimum drying;
- Ergonomic positioning of adjustable
- Wide variety of transport and loading trolleys, internal racks, shelves, trays and containers, customized solutions for individual needs;
- Full and easy accessibility to technical area from the front and lateral side for service and regular maintenance;
- High level of programming and application flexibility with fully configurable cycles;
- Multilevel password management for authorized access only;
- Special stadndard test programs (i.e. Bowie Dick, vacuum, pressure leak test, heating programs, etc.) for routine check of sterilizer efficiency;
- GMP / GLP compatible data management offering full traceability and documentation, meeting the most stringent worldwide safety and quality standards.