Hygiena SystemSURE PLUS™ ATP Bioluminescence Detector

Overview

The Hygiena SystemSURE PLUS™ ATP Bioluminescence Detector is a handheld, field-deployable instrument engineered for rapid, quantitative assessment of surface hygiene and cleaning efficacy in food production, healthcare, pharmaceutical, and hospitality environments. It operates on the principle of bioluminescence—measuring adenosine triphosphate (ATP) as a universal biomarker of organic residue. When ATP reacts with luciferase and luciferin (supplied in Hygiena’s UltraSnap™ swabs), light emission (photons) is generated proportionally to ATP concentration. The SystemSURE PLUS™ captures this signal via a high-sensitivity photodiode detector, converting photon flux into relative light units (RLUs) with traceable linearity across 0–9999 RLU. Designed for compliance-driven workflows, it supports real-time verification of sanitation protocols without requiring laboratory infrastructure—making it integral to HACCP, HARPC, and ISO 22000-aligned food safety management systems.

Key Features

• High-fidelity photodiode detection system optimized for low-light sensitivity and minimal thermal drift, enabling consistent RLU quantification across ambient temperature fluctuations (5–40 °C).
• UltraSnap™ ATP swabs integrate liquid-phase reagents—eliminating lyophilized enzyme reconstitution steps and reducing operator-induced variability.
• Swab stability profile: 12 months refrigerated (2–8 °C); 6 weeks at ambient temperatures ≤25 °C—no freezing required, minimizing cold-chain dependency.
• Pre-moistened swab tip reduces cross-contamination risk during sampling and improves recovery efficiency from uneven or porous surfaces.
• On-device data management: stores up to 2000 test results with timestamps, user IDs, location tags, and programmable pass/fail thresholds.
• Configurable protocol architecture: 251 user-defined limit sets, 20 customizable program groups, and individual user authentication support multi-shift or multi-site deployment.
• Ergonomic, palm-sized form factor (72 × 191 × 32 mm; ~269 g) with tactile button interface—designed for glove-compatible operation in wet or chilled environments.

Sample Compatibility & Compliance

The SystemSURE PLUS™ is validated for use with Hygiena UltraSnap™ and EnviroSnap™ ATP swabs, which meet AOAC PTM (Performance Tested Method) certification requirements for environmental monitoring. Swab design ensures >90% ATP recovery from stainless steel, plastic, ceramic, and food-contact polymers per ASTM E2871-22. Instrument firmware complies with FDA 21 CFR Part 11 data integrity requirements when used with SURE Trend™ software, supporting audit-ready electronic records including full audit trails, electronic signatures, and secure user access controls. It aligns with ISO 22000:2018 Clause 8.2 (Prerequisite Programs), BRCGS Food Safety Issue 9 Section 4.10.2, and SQF Code Edition 9.2 Section 2.6.2 for environmental monitoring validation.

Software & Data Management

SURE Trend™ v4.x is a Windows-based analytical platform certified for GLP/GMP environments. It imports raw RLU data via RS-232 interface, auto-generates trend charts (time-series, zone-based, shift-comparative), calculates statistical process control (SPC) metrics (e.g., mean, SD, % deviation), and exports reports in PDF, CSV, or Excel formats compliant with internal QA review cycles. The software enforces role-based permissions, encrypted database storage, and immutable audit logs—including timestamped record creation/modification events and user login/logout histories—fulfilling FDA 21 CFR Part 11 Subpart C electronic record requirements. Optional cloud synchronization enables centralized dashboards for enterprise-wide hygiene performance benchmarking.

Applications

• Post-clean verification of food processing lines (conveyors, mixers, fillers, slicers) per USDA-FSIS Directive 7120.1 and FDA Food Code §3-302.12.
• Routine environmental monitoring in Grade A dairy plants, ready-to-eat (RTE) facilities, and fresh-cut produce packing houses.
• Healthcare surface screening (operating rooms, ICU equipment, endoscope reprocessing stations) aligned with CDC Guideline for Disinfection and Sterilization.
• Validation of sanitation standard operating procedures (SSOPs) during regulatory audits (FDA, CFIA, EFSA) or third-party certifications (BRC, SQF, IFS).
• Training and competency assessment for sanitation staff using objective, numeric RLU benchmarks instead of subjective visual inspection.

FAQ

What does an RLU value represent, and how is it calibrated?
RLU (Relative Light Unit) is a dimensionless output proportional to detected photon count. Calibration is performed at the factory using NIST-traceable ATP standards; no user recalibration is required. Each instrument ships with a Certificate of Conformance documenting linearity (R² ≥ 0.999) across the 0–9999 RLU range.

Can UltraSnap™ swabs be used with non-Hygiena luminometers?
Yes—UltraSnap™ swabs are chemically compatible with most ATP luminometers using firefly luciferase chemistry, though optimal performance (e.g., LOD, reproducibility) is guaranteed only with Hygiena instruments due to proprietary reagent formulation and optical alignment.

Is the SystemSURE PLUS™ suitable for GMP-regulated pharmaceutical cleanrooms?
While primarily deployed in food and healthcare, its data integrity features (audit trail, user authentication, electronic signatures via SURE Trend™) support qualification under EU Annex 11 and USP Analytical Instrument Qualification frameworks when integrated into validated cleaning verification protocols.

How does battery life perform under continuous field use?
With alkaline AA cells, the device delivers ≥2000 consecutive measurements at 20 °C. In intermittent use (typical for shift-based hygiene checks), battery service life exceeds six months—verified per IEC 60086-2 discharge testing protocols.