LabDream INFINITY HEPSS-B Air-Cooled Pure Steam Condensate Sampler

Overview

The LabDream INFINITY HEPSS-B Air-Cooled Pure Steam Condensate Sampler is an engineered solution for continuous, non-invasive collection of sterile condensate from pharmaceutical-grade pure steam distribution systems. It operates on the principle of controlled convective heat exchange—using ambient air as the sole cooling medium—to condense saturated steam into liquid phase without introducing water or refrigerants into the sampling path. This eliminates cross-contamination risk, avoids thermal shock to sensitive components, and ensures compliance with core requirements of Annex 1 (EU GMP), USP <1231>, and ISO 14644-1 Class A/B environmental monitoring protocols. Unlike water-cooled samplers requiring external chillers or plumbing, the HEPSS-B integrates passive thermal management with active airflow control, enabling stable condensation across variable ambient conditions (15–30 °C). Its compact footprint and self-contained operation make it suitable for point-of-use validation at autoclaves, SIP manifolds, sterilizers, and isolator steam inlets.

Key Features

• Forced-air convection cooling system with thermally optimized finned heat exchanger—no external coolant, no condensate dilution, no risk of water ingress.
• Electropolished 316L stainless steel steam pathway (Ra ≤ 0.4 µm) compliant with ASME BPE-2022 surface finish standards; fully traceable material certification available.
• Sanitary PTFE-lined flexible tubing routed with zero dead-leg geometry; all internal joints conform to ISO 2852 clamp specifications.
• Integrated 0.2 µm hydrophobic particulate pre-filter on air intake to prevent dust ingress during prolonged operation.
• Modular control interface supporting three operational states: sampling (timed or continuous), automated post-sampling purge cycle, and integrated thermal sterilization mode (validated up to 121 °C, 30 min).
• Real-time status indicators for flow continuity, temperature deviation (>±5 °C from setpoint), and condensate accumulation; configurable audible/visual alarms per IEC 62304 Class B software safety requirements.

Sample Compatibility & Compliance

The HEPSS-B collects representative, microbiologically intact condensate samples directly from pure steam lines operating at pressures between 1.5–3.5 bar(g) and temperatures up to 135 °C. Sample integrity is preserved through non-contact condensation and immediate transfer into sterile, pyrogen-free containers (e.g., ISO 8573-1 Class 1 compliant glass vials or USP <797> validated polypropylene tubes). All wetted materials meet EP 10.0 and USP Class VI biocompatibility criteria. The device itself is constructed and documented in accordance with ISO 13485:2016 quality management system requirements for medical device manufacturers. Design verification includes thermal mapping per ASTM E2297-22, pressure decay leak testing per ISO 15883-4, and electromagnetic compatibility assessment per IEC 61326-1. It supports audit readiness for FDA 21 CFR Part 11 (with optional electronic log export), EU Annex 1 Annex II, and WHO TRS 986 Annex 6 validation frameworks.

Software & Data Management

The embedded microcontroller logs timestamped operational parameters—including inlet steam temperature, ambient air temperature, cumulative sampling volume, and alarm events—with local storage (non-volatile flash memory, 10,000-cycle endurance). Data export is supported via USB-C interface in CSV format, compatible with LIMS integration (e.g., LabVantage, STARLIMS) and electronic batch record systems. Optional firmware upgrade enables Bluetooth 5.0 connectivity for remote status monitoring and configuration via secure mobile application (iOS/Android). Audit trail functionality records user actions, parameter changes, and mode transitions with immutable timestamps—fully aligned with ALCOA+ principles and GxP data integrity expectations.

Applications

• Validation and routine monitoring of pure steam systems during commissioning, periodic requalification, and change control activities.
• End-point sampling for endotoxin testing (USP <85>) and microbial enumeration (USP <61>/<62>) in aseptic processing facilities.
• Supporting media fill investigations where steam quality impacts sterility assurance level (SAL).
• On-site use during regulatory inspections (FDA, MHRA, PMDA) due to portability, rapid setup (<5 min), and absence of utility dependencies.
• Integration into automated cleaning-in-place (CIP) and sterilization-in-place (SIP) validation protocols for bioreactors and filling lines.

FAQ

Does the HEPSS-B require external power for cooling?
No. The unit uses only standard 24 VDC input for fan operation and control logic; cooling is achieved solely through forced-air convection—no chiller, no water supply, no refrigerant.
Can it be used in classified environments (ISO 5 or better)?
Yes. With optional HEPA-filtered air intake and static-dissipative housing finish, it meets ISO 14644-1 Class 5 particle emission limits when operated within laminar flow hoods or RABS.
Is the condensate sample representative of steam quality?
Yes. Condensation occurs under dynamic equilibrium conditions with minimal residence time (<2 s), preserving volatile organic compounds, non-condensable gases, and particulate load per ISO 14644-12 guidance.
What maintenance is required?
Quarterly inspection of fan performance, filter replacement, and visual verification of PTFE hose integrity; no calibration required per ASTM E2911-21 for condensate samplers.
How is sterility maintained during repeated use?
The integrated sterilization cycle subjects internal surfaces to ≥121 °C saturated steam for ≥30 minutes; validation reports include thermocouple mapping and biological indicator challenge data (Geobacillus stearothermophilus spores).