MMM Sterivap Pulsed Vacuum Steam Sterilizer
| Brand | MMM |
|---|---|
| Origin | Germany |
| Model | Sterivap |
| Type | Vertical Autoclave |
| Chamber Volume | 148–2056 L |
| Construction Material | AISI 316L Stainless Steel Chamber & Double Jacket |
| Compliance | EN 285, EN 554, EN ISO 11134, prEN 866-4 to -8, prEN 868-9 to -10, ISO 14161, ASME BPVC Section VIII, PED 97/23/EC, IEC 61010, HTM 2010/2031, 21 CFR Part 11 (with optional software), GLP/GMP-ready |
| Safety Features | Dual CPU Control, Independent Pressure & Temperature Sensors, Mechanical Door Interlock, Overpressure & Low-Water Cut-off, HEPA-Filtered Air Inlet/Exhaust, P3/P4 Biological Sealing |
| Vacuum System | Two-Stage Water-Ring Vacuum Pump with 70% Reduced Water Consumption |
| Control Interface | 8.2" Touchscreen HMI with Real-Time Curve Logging |
| Standard Programs | 4 Predefined + Up to 14 Customizable Cycles (incl. BD Test, VT Test, Preheat) |
| Optional | Integrated Pure Steam Generator (EN 285 Compliant), F₀-Control Software, IQ/OQ Documentation Package, Mobile PT100 Probe, Rapid Cooling Module, Air Content Sensor |
Overview
The MMM Sterivap Pulsed Vacuum Steam Sterilizer is a CE-marked, vertically oriented Class B vacuum-assisted autoclave engineered for high-integrity terminal sterilization of heat-stable and heat-labile loads in regulated laboratory, pharmaceutical, and biosafety environments. Based on the validated principles of saturated steam under controlled vacuum cycles—complying with EN 285 (large sterilizers) and EN 554 (validation standards)—the Sterivap achieves complete air removal via repeated pulsing (pre-vacuum and post-sterilization vacuum drying), ensuring uniform steam penetration into porous, wrapped, and hollow loads. Its dual-jacketed AISI 316L stainless steel chamber minimizes thermal gradients and improves steam economy, while the integrated two-stage vacuum system delivers stable sub-10 mbar residual pressure with minimal water consumption. Designed and manufactured in Germany per ASME BPVC Section VIII and EU Pressure Equipment Directive (PED 97/23/EC), the Sterivap meets stringent mechanical, electrical, and electromagnetic compatibility requirements (EN 61010, 73/23/EEC, 89/336/EEC) and carries TÜV-certified safety certification.
Key Features
- Dual independent microprocessor control system (main + backup CPU) with real-time monitoring of chamber pressure, jacket pressure, temperature (via calibrated PT100 sensors), and vacuum level
- AISI 316L stainless steel double-jacketed chamber with electropolished internal surface (Ra ≤ 0.38 µm / 15 µin), optimized for corrosion resistance and cleanability in GxP environments
- Triangular steam distribution nozzle ensures laminar, turbulence-free steam entry—maximizing thermal uniformity across the entire load volume
- Two-stage water-ring vacuum pump with integrated heat exchanger, condensate separator, and closed-loop cooling water recirculation (70% reduction in water usage vs. conventional systems)
- 8.2-inch color touchscreen HMI with intuitive menu navigation, graphical real-time display of sterilization curves (T vs. t, P vs. t), and remaining cycle time countdown
- Integrated thermal printer providing auditable hard-copy records of all critical process parameters—including timestamps, absolute pressure, chamber temperature, and vacuum profile
- Mechanically interlocked vertical or horizontal sliding door with AISI 316L construction (6 mm thick), insulated outer panel, motorized actuation, and redundant safety sensors preventing operation under unsafe pressure differentials
- Comprehensive safety architecture: overpressure relief valves (HERO certified), low-water cutoff, door position verification, pinch-point protection, and automatic fail-safe shutdown on parameter deviation
Sample Compatibility & Compliance
The Sterivap accommodates a broad spectrum of sterilizable materials—including surgical instruments, glassware, filtration devices, animal cage bedding, liquid media (open/closed vessels), agar plates, biological waste (BSL-2/3), and heat-sensitive polymers—through programmable cycle configurations. Its pulse-vacuum methodology satisfies EN ISO 11134 for validation of steam sterilization processes and supports compliance with FDA 21 CFR Part 11 when paired with optional audit-trail-enabled software (e.g., Unicoflg). The system conforms to HTM 2010 (UK) and HTM 2031 for healthcare decontamination, and its P3/P4-compatible sealing design—equipped with HEPA-filtered inlet/exhaust and gas-lock door mechanisms—enables safe operation in containment laboratories. All wetted components meet USP material classification requirements; chamber surface finish complies with ISO 13485 and EN 17172 for medical device manufacturing.
Software & Data Management
Standard firmware includes four pre-validated cycles (solid, liquid, agar, waste), BD test, vacuum tightness (VT) test, and preheat function. Up to 14 user-defined programs may be stored and password-protected via the HMI interface. Optional Unicoflg software enables advanced parameter editing—including F₀-based cycle calculation, adjustable vacuum dwell times, dynamic drying profiles, and ±2°C temperature fine-tuning—with full electronic signature support for 21 CFR Part 11 compliance. The system logs all process data internally (≥10,000 cycles) and exports CSV-formatted reports via USB. IQ/OQ documentation packages are available for installation qualification and operational qualification per ISO 13485 and Annex 11 guidelines. Remote diagnostics and firmware updates are supported via secure Ethernet connection.
Applications
The Sterivap serves as a primary sterilization platform in cGMP pharmaceutical R&D labs, academic core facilities, biotech pilot plants, veterinary diagnostic centers, and high-containment (P3/P4) research institutions. It is routinely deployed for sterilizing culture media prior to aseptic processing, decontaminating biohazardous animal carcasses and lab waste, validating steam penetration in complex device packaging, and qualifying autoclave performance for ISO 17025-accredited testing laboratories. Its modular configuration supports integration into automated lab infrastructure—compatible with LIMS interfaces and central utility monitoring systems—while maintaining full traceability for regulatory inspections (FDA, EMA, MHRA).
FAQ
What standards does the Sterivap comply with for pharmaceutical sterilization?
It meets EN 285, EN 554, ISO 11134, and HTM 2010; optional F₀-control and Part 11 software enable compliance with FDA 21 CFR Part 11 and EU Annex 11.
Can the Sterivap sterilize liquids in sealed containers?
Yes—programmable slow-cool and pressure-balanced cycles prevent boil-over and container rupture during sterilization of liquids in capped bottles or flasks.
Is pure steam generation available as an integrated option?
Yes—the optional built-in pure steam generator produces EN 285-compliant steam using AISI 316L components and automated water-level management.
How is validation support provided for GMP environments?
MMM supplies IQ/OQ protocols, calibration certificates, and FAT/SAT documentation; on-site qualification assistance is available through authorized service partners.
What maintenance intervals are recommended for the vacuum system?
The two-stage vacuum pump requires oil change every 2,000 operating hours; condensate traps and HEPA filters should be inspected quarterly per preventive maintenance schedule.
