English Product Name
| Brand | Beifen Sanpu |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Manufacturer |
| Region of Origin | Domestic (China) |
| Model | ALHS-20A PLUS |
| Instrument Type | Static Headspace Sampler |
| Automation Level | Fully Automatic |
| Vial Heating Range | Ambient to 200 °C (1 °C increment) |
| Valve Temperature Control Range | 40–220 °C (±1 °C accuracy) |
| Sample Loop Volume | 1 mL |
| Sample Capacity | 20 positions |
| Compatible Vial Sizes | 10 mL or 20 mL |
Overview
The Beifen Sanpu ALHS-20A PLUS is a fully automated static headspace sampler engineered for precise, reproducible quantification of residual ethylene oxide (EO) in sterilized medical devices. It operates on the principle of equilibrium headspace gas-phase extraction: solid or liquid samples are sealed in heated vials, allowing volatile EO to partition into the headspace above the matrix. A precisely metered volume of this equilibrated vapor is then transferred—via thermostatically controlled injection valve and loop—to a coupled gas chromatograph (GC) for separation and detection. This methodology complies with the thermodynamic and kinetic requirements specified in ISO 10993-7 and ASTM F1838, ensuring trace-level sensitivity (sub-µg/g), minimal carryover, and robust inter-laboratory reproducibility essential for regulatory submission and quality control in Class II/III medical device manufacturing.
Key Features
- Fully automated 20-position carousel with programmable vial handling, eliminating manual intervention and reducing operator-induced variability.
- Independent dual-zone temperature control: vial oven (ambient to 200 °C, ±0.5 °C stability) and injection valve (40–220 °C, ±1 °C precision), enabling method optimization for diverse polymer matrices including PVC, polyethylene, and nonwoven fabrics.
- 1 mL fixed-volume sample loop with inert SilcoNert®-treated stainless-steel pathway, minimizing adsorption and ensuring quantitative transfer of EO across concentration ranges from 0.1 to 50 µg/g.
- Integrated leak-tight sealing mechanism and pressure-balanced vial piercing system, validated per USP and ISO 11135 Annex D for consistent headspace pressurization and reproducible phase equilibrium.
- Embedded firmware with audit-trail-enabled method storage, user access levels, and timestamped run logs—designed to support compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures.
Sample Compatibility & Compliance
The ALHS-20A PLUS accommodates standard 10 mL and 20 mL crimp-top headspace vials, compatible with common sample preparation formats used in EO residue testing—including aqueous extraction of cut specimens (e.g., 1.0 g device segment + 5.0 mL ultrapure water). It supports all major GC platforms (e.g., Shimadzu GC-2010, Agilent 8890) via industry-standard electrical and pneumatic interfaces. The system meets the instrumental performance criteria outlined in GB/T 16886.7–2015 (equivalent to ISO 10993-7:2008), GB/T 14233.1–2022, and YY/T 0698.8–2011. Validation documentation includes IQ/OQ protocols aligned with ISO/IEC 17025:2017 for testing and calibration laboratories.
Software & Data Management
Controlled via Beifen Sanpu’s HS-Link™ software (Windows 10/11 compatible), the ALHS-20A PLUS enables method development with up to 99 customizable parameters—including equilibration time, agitator speed (if equipped), oven ramp profiles, and multi-step valve sequencing. All acquisition parameters, raw chromatograms, and calculated EO concentrations are stored in a relational database with automatic backup. Software features include electronic signature capability, role-based permissions (admin/operator/auditor), and export to CSV, PDF, or LIMS-compatible XML formats. Audit trails record every parameter change, user login/logout, and instrument error event—fully traceable for GLP/GMP audits and regulatory inspections.
Applications
This headspace sampler is deployed exclusively for residual EO analysis in final-product release testing of ethylene oxide-sterilized single-use medical devices. Validated applications include but are not limited to: sterile syringes, IV infusion sets, blood transfusion sets, plasma separation cups, leukocyte reduction filters, urinary catheters, surgical gowns and masks, spunbond-meltblown-spunbond (SMS) face masks, implantable drug delivery systems, and tissue expanders. It also supports extractables/leachables studies under ISO 10993-12 and supports method transfer between QC labs operating under ISO 13485 quality management systems.
FAQ
What regulatory standards does the ALHS-20A PLUS directly support?
It is validated for use in methods compliant with ISO 10993-7, GB/T 16886.7–2015, GB/T 14233.1–2022, YY/T 0698.8–2011, and ASTM F1838.
Can the system be integrated with third-party GC data systems?
Yes—via RS-232, USB, or Ethernet interfaces; driver support is provided for OpenLab CDS, Chromeleon, and GCsolution software.
Is method validation documentation included?
Yes—factory-issued IQ/OQ protocols, system suitability test reports, and EO-specific precision/recovery data (per ISO 10993-17) are supplied with each unit.
What maintenance is required to sustain compliance?
Scheduled preventive maintenance includes quarterly valve seal inspection, annual loop volume verification using certified gas standards, and biannual oven calibration traceable to NIST-certified reference materials.
Does the system support unattended overnight operation?
Yes—the 20-vial capacity, auto-shutdown logic, and thermal safety cutoffs enable fully unattended batch runs exceeding 12 hours.
