LabDream INFINITY SQD Automatic Pure Steam Quality Tester with Integrated Condensate Sampler
| Brand | LabDream |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | INFINITY SQD |
| Pricing | Available Upon Request |
Overview
The LabDream INFINITY SQD Automatic Pure Steam Quality Tester is a fully integrated, CE-compliant condensate sampling and analysis system engineered for routine validation and continuous monitoring of pure steam used in pharmaceutical sterilization processes. It operates in strict accordance with the requirements of EN 285:2015 — *Sterilization – Steam Sterilizers – Large Steam Sterilizers* — and supports compliance with FDA 21 CFR Part 11, EU Annex 1, and ISO 13485 quality management systems. The instrument performs three critical quality parameters in a single automated cycle: steam dryness fraction (dryness value), degree of superheat, and non-condensable gas (NCG) volume concentration. Unlike manual test kits requiring sequential assembly, timed collection, and manual calculation, the INFINITY SQD executes all sampling, phase separation, temperature stabilization, volumetric measurement, and result computation autonomously — eliminating operator-dependent variability and reducing total test duration by 20–30 minutes per run.
Key Features
- Integrated condensate sampler and analyzer housed in a single stainless-steel enclosure (316L wetted parts), designed for permanent installation in pure steam distribution lines or mobile use in validation campaigns.
- Automated dryness determination via gravimetric condensate collection and real-time thermal equilibrium verification — compliant with EN 285 Annex C methodology.
- Superheat measurement using dual calibrated Pt100 sensors (±0.1 °C accuracy) placed upstream and downstream of the throttling orifice to calculate enthalpy-based temperature rise.
- NCG quantification via volumetric displacement in a calibrated glass syringe chamber, with automatic air–water interface detection and temperature-compensated volume readout (per EN 285 Section 5.3.3).
- Self-contained operation: no external water supply, compressed air, or auxiliary power required — powered solely by standard 230 V AC; steam inlet pressure range: 1.5–4.0 bar(g).
- IP65-rated industrial touchscreen HMI with multilingual UI (English default), guided workflow navigation, and audit-trail-enabled user authentication.
Sample Compatibility & Compliance
The INFINITY SQD is validated for use with saturated pure steam generated from purified water (PW) or water-for-injection (WFI) sources, meeting USP <1231>, EP 2.6.1, and JP 2.07 specifications. It accommodates nominal pipe sizes DN15–DN50 and integrates seamlessly with common steam trap configurations and point-of-use sampling ports. All materials in contact with condensate — including condenser coil, collection vessel, and NCG chamber — are electropolished 316L stainless steel (Ra ≤ 0.4 µm) and passivated per ASTM A967. The system supports full GMP documentation packages, including IQ/OQ protocols, calibration certificates traceable to NIST standards, and raw data export in CSV and PDF formats compliant with ALCOA+ principles.
Software & Data Management
Firmware v3.2+ includes embedded data logging with time-stamped, user-identifiable records for every test cycle. Each report contains: test date/time, operator ID, steam line ID, dryness value (reported as decimal ≥0.95), superheat (°C, max limit 25 °C), NCG volume (mL per 100 mL condensate, max limit 3.5 mL), and system diagnostic flags. Data integrity is enforced through role-based access control (RBAC), electronic signatures, and immutable audit trails satisfying FDA 21 CFR Part 11 Subpart B requirements. Optional Ethernet/Wi-Fi connectivity enables secure integration with LIMS or MES platforms via OPC UA or RESTful API.
Applications
- Periodic requalification of autoclaves, SIP systems, and tunnel sterilizers per EN 285 and ISO 17665.
- Commissioning and routine monitoring of pure steam generators (PSGs) and distribution networks in biopharma clean utilities.
- Supporting regulatory inspections (FDA, EMA, PMDA) with auditable, paperless evidence of ongoing steam quality conformance.
- Root cause analysis during process deviations involving sterilization failures or microbial contamination events.
- Training and competency assessment for utilities technicians and QA/QC personnel under GLP/GMP frameworks.
FAQ
Does the INFINITY SQD require external cooling water or compressed air to operate?
No — it is a self-contained unit requiring only steam supply and 230 V AC power. Internal thermosiphon condensation and passive NCG displacement eliminate auxiliary utilities.
Can test results be exported for regulatory submission?
Yes — reports are generated in PDF and CSV formats with embedded digital signatures, timestamps, and device-specific metadata required for FDA/EU submissions.
What calibration standards are supported?
The system ships with factory calibration against NIST-traceable temperature and volumetric references; annual recalibration services include full metrological verification per ISO/IEC 17025.
Is the INFINITY SQD suitable for use in classified cleanrooms?
Yes — its compact footprint (W420 × D310 × H580 mm), low particulate emission design, and smooth, crevice-free surfaces meet ISO 14644-1 Class 5 compatibility when installed with appropriate isolators.
How does the system ensure compliance with EN 285 dryness measurement methodology?
It implements the standardized throttling calorimetry approach defined in EN 285 Annex C, including controlled expansion, thermal equilibration, and mass-based dryness calculation — with all procedural steps executed and logged automatically.
