INFINITY HEPSS Hipro Pure Steam Condensate Sampler by LabDream

Overview

The INFINITY HEPSS Hipro Pure Steam Condensate Sampler is an air-cooled, portable sampling instrument engineered for routine and validation-grade condensate collection from pharmaceutical-grade pure steam distribution systems. Unlike water-cooled or chilled-loop samplers, the Hipro leverages passive convection and optimized finned heat exchange to achieve consistent condensation without external coolant, eliminating risks associated with glycol leaks, refrigerant maintenance, or secondary contamination pathways. Its operation is grounded in thermodynamic phase transition principles: saturated pure steam enters the 316L stainless steel primary condensation path, where rapid heat dissipation via the anodized aluminum housing induces controlled condensation into sterile liquid water—preserving critical quality attributes including endotoxin levels, conductivity, and microbial integrity. Designed explicitly for compliance-driven environments, the Hipro supports continuous monitoring during system qualification (IQ/OQ/PQ), routine surveillance, and periodic revalidation of autoclaves, SIP (steam-in-place) circuits, and sterilization tunnels.

Key Features

• Air-cooled condensation architecture: No external cooling media required; eliminates dependency on chilled water loops or refrigeration units—reducing infrastructure complexity and operational safety hazards.
• High-fidelity sample preservation: Entire steam-wetted path constructed from electropolished 316L stainless steel and PTFE tubing; zero dead-leg design ensures complete drainage and blow-down capability for microbiological control.
• Integrated intelligent purge system: Programmable air blow-down cycle activates post-sampling, using filtered compressed air (HEPA-class inlet filter) to evacuate residual condensate and moisture from all internal pathways—critical for preventing biofilm formation between sampling events.
• GMP-optimized mechanical design: Anodized aluminum chassis provides corrosion resistance, non-shedding surface finish, and compatibility with standard vapor-phase hydrogen peroxide (VHP) and saturated steam sterilization protocols.
• Modular quick-connect interface: Tri-clamp (DIN 11851) and sanitary ferrule fittings enable tool-free installation onto existing pure steam manifolds—minimizing downtime during deployment or relocation.
• Onboard functional modes: Dedicated firmware-controlled sequences for sampling, thermal sterilization (121°C hold), automated purge, and fault-triggered alarm logging—each timestamped and audit-trail ready.

Sample Compatibility & Compliance

The INFINITY HEPSS Hipro is validated for use with saturated pure steam meeting USP <1231>, EP 2.6.27, and JP 2.05 specifications. It maintains sample integrity across pressure ranges of 1–3.5 bar(g) and temperature gradients from 105°C to 135°C. All wetted materials comply with FDA 21 CFR Part 177 (PTFE) and ASTM A276 (316L SS), and the unit’s construction adheres to ISO 13485:2016 requirements for medical device manufacturing equipment. The device supports GLP/GMP data integrity standards through deterministic cycle sequencing, non-volatile event logging, and user-accessible calibration verification points. It is routinely deployed in facilities undergoing FDA pre-approval inspections, MHRA audits, and EMA Annex 1 assessments for aseptic process simulation and steam quality mapping.

Software & Data Management

While the Hipro operates as a standalone hardware platform, its embedded controller records all operational events—including start/stop timestamps, temperature profiles during sterilization cycles, purge duration, and alarm triggers (e.g., overpressure, low airflow, incomplete blow-down)—in a tamper-resistant internal memory buffer. Data export is supported via USB-C interface in CSV format, compatible with LIMS integration and electronic batch record (EBR) systems. Audit trail functionality satisfies FDA 21 CFR Part 11 requirements when paired with enterprise-level access controls and digital signature workflows. Optional firmware updates are delivered via secure authenticated channels and include version-locked configuration locks to prevent unauthorized parameter modification.

Applications

• Validation of pure steam systems per ISO 14644-3 and EU GMP Annex 1 Section 8.122–8.128.
• Endotoxin and microbial testing of condensate in biopharmaceutical clean utilities.
• Periodic verification of steam dryness value (DV) and non-condensable gas (NCG) content during routine QC.
• Supporting media fill investigations and aseptic process risk assessments.
• Mobile sampling across multi-point steam networks in large-scale API and vaccine manufacturing suites.

FAQ

Does the Hipro require external power during sampling?
Yes—it operates on a rechargeable lithium-ion battery pack rated for 8 hours of continuous sampling at 280 mL/min under ambient conditions of 20–25°C.
Can the unit be sterilized in place (SIP)?
Yes—the entire steam path is rated for repeated exposure to saturated steam at 121°C for 30 minutes; full cycle parameters are programmable and logged.
Is the condensate collection vessel included?
No—the Hipro delivers condensate directly into user-provided, pre-sterilized Class VI-compliant containers (e.g., borosilicate glass vials or polypropylene tubes); no integrated reservoir is used to avoid cross-contamination.
How is calibration verified?
Calibration is confirmed via traceable thermocouple validation at inlet/outlet ports and volumetric flow verification using NIST-traceable rotameters; certificate of conformance is supplied with each unit.
What regulatory documentation is provided?
Each shipment includes a Device Master Record (DMR)-aligned Declaration of Conformity, material certifications (EN 10204 3.1), and a GxP-ready Installation Qualification (IQ) protocol template.