testo UltraRange Gateway 0572 9310

Overview

The testo UltraRange Gateway 0572 9310 is a purpose-built industrial communication interface engineered to bridge testo’s proprietary UltraRange wireless sensor network with standard Ethernet-based infrastructure. Designed exclusively for integration into the testo Saveris Pharma environmental monitoring system, this gateway enables secure, low-latency transmission of calibrated temperature and humidity measurement data from up to 40 distributed testo 150 wireless data logger modules. Unlike conventional Wi-Fi or Bluetooth-based telemetry, UltraRange employs a licensed-free 868 MHz ISM band with frequency-hopping spread spectrum (FHSS) modulation and AES-128 encryption—ensuring robust signal penetration through reinforced concrete, metal cabinets, and multi-floor pharmaceutical facilities where standard RF protocols suffer attenuation or packet loss. The gateway operates as a deterministic node in a star topology, assigning unique MAC addresses to each connected module and maintaining time-synchronized data acquisition cycles compliant with EU GMP Annex 15 and FDA 21 CFR Part 11 requirements for audit-ready environmental data integrity.

Key Features

• Dedicated UltraRange protocol support: Enables reliable bidirectional communication over distances up to 100 m indoors (line-of-sight) and 30–50 m through three standard concrete walls—validated per EN 300 220-1 for sub-GHz radio equipment.
• Ethernet-native integration: Provides seamless connectivity to existing IT networks via 10/100BASE-TX (RJ45), supporting static IP, DHCP, and DNS configuration for enterprise-level deployment.
• Modular system compatibility: Functions as the central hub for testo Saveris Pharma, enabling concurrent polling and firmware updates across all registered testo 150 loggers without channel contention.
• Secure data handling: Implements TLS 1.2 for upstream data transport to testo Saveris Cloud or on-premise servers; local data buffering (up to 72 hours at 15-min intervals) ensures continuity during network outages.
• Industrial-grade enclosure: IP20-rated housing with DIN-rail mounting option and operating temperature range of 0 °C to +45 °C—designed for continuous operation in controlled room environments (CREs), cold rooms, and stability chambers.

Sample Compatibility & Compliance

The testo UltraRange Gateway is certified for use only with testo-branded UltraRange-compatible devices, primarily the testo 150 series of wireless temperature/humidity data loggers (e.g., 0572 1501, 0572 1502). It does not support third-party sensors or legacy testo Saveris 2 hardware. All data streams comply with ISO 17025 traceability frameworks when paired with testo-calibrated probes, and system validation documentation—including IQ/OQ templates, risk assessments, and alarm response logs—is provided under testo’s GxP-compliant Saveris Validation Package. The gateway itself meets electromagnetic compatibility (EMC) standards EN 301 489-1 and EN 301 489-17, ensuring coexistence with other medical and laboratory equipment in regulated environments.

Software & Data Management

The gateway operates transparently within the testo Saveris software ecosystem. Configuration is performed via web-based GUI accessible over local network (HTTPS), requiring no additional drivers or client software. All logged measurements are timestamped with NTP-synchronized UTC time and stored in encrypted SQLite databases on the gateway before forwarding to the central Saveris server. Audit trails capture every configuration change, user login event, and alarm activation with immutable SHA-256 hashing—fully satisfying FDA 21 CFR Part 11 electronic record and signature requirements. Role-based access control (RBAC), configurable alarm escalation paths (email/SMS/SNMP traps), and automated PDF report generation (per ISO 14644-3 and USP ) are managed centrally—not at the gateway level—ensuring consistent policy enforcement across multi-site deployments.

Applications

• Pharmaceutical warehouse and cold chain monitoring: Continuous validation of storage conditions for APIs, finished dosage forms, and biologics per ICH Q5C and WHO TRS 992 Annex 9.
• Stability testing chambers: Synchronized multi-point logging across ICH Q1A(R2)-defined temperature/humidity stress conditions (e.g., 25 °C/60 %RH, 40 °C/75 %RH).
• Hospital pharmacy refrigerators and ultra-low freezers: Real-time deviation alerts for critical storage units holding vaccines, blood products, or investigational drugs.
• Medical device manufacturing cleanrooms: Integration with HVAC monitoring systems to correlate environmental parameters with particle count and pressure differential data.
• Contract development and manufacturing organizations (CDMOs): Scalable deployment across multiple validated facilities with centralized data governance and e-signature workflows.

FAQ

Does the testo UltraRange Gateway support Power over Ethernet (PoE)?
No. The gateway requires an external 12 V DC power supply (not included); PoE functionality is not implemented.
Can it be used outside the testo Saveris Pharma ecosystem?
No. It is not interoperable with non-testo platforms or generic MQTT/OPC UA brokers—it relies on proprietary protocol stacks and certificate-based authentication.
What is the maximum number of testo 150 modules supported per gateway?
Up to 40 modules, with guaranteed latency ≤ 2.5 seconds per full polling cycle under nominal RF load.
Is firmware update capability available over-the-air?
Yes—updates are delivered via the Saveris server and applied during scheduled maintenance windows with rollback support.
Does the gateway store historical data locally if the network connection fails?
Yes—internal flash memory retains up to 72 hours of aggregated interval data (configurable sampling rate: 15 sec to 24 h) before automatic overwrite.