Shimadzu Py-Screener RoHS Screening System
| Brand | Shimadzu |
|---|---|
| Origin | Japan |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Import Status | Imported |
| Model | Py-Screener |
| Instrument Type | Single Quadrupole Mass Spectrometer |
| Chromatography Type | Pyrolysis-Gas Chromatography Coupled with Mass Spectrometry (Py-GC/MS) |
| Mass Range | 1.5–1090 u |
| Resolution | Unit Mass Resolution |
| Sensitivity | >1500:1 (Signal-to-Noise Ratio, S/N) |
| Scan Speed | 20,000 u/s |
Overview
The Shimadzu Py-Screener RoHS Screening System is a dedicated analytical platform engineered for rapid, reliable, and regulatory-compliant screening of restricted organic substances under the EU RoHS Directive (2011/65/EU, as amended), with primary focus on phthalate esters—including DIBP, DBP, BBP, DEHP, DNOP, DINP, and DIDP—in polymeric materials such as PVC cables, plastic housings, and elastomeric components. Unlike conventional GC-MS workflows requiring extensive sample preparation and derivatization, the Py-Screener integrates micro-furnace pyrolysis directly upstream of a single quadrupole mass spectrometer, enabling direct thermal desorption and real-time analysis of target analytes without solvent extraction or cleanup steps. This pyrolysis-GC/MS (Py-GC/MS) architecture delivers high reproducibility in semi-quantitative screening across complex matrices, supporting laboratories in electronics manufacturing, third-party testing labs (e.g., SGS-accredited facilities), and RoHS compliance verification units operating under ISO/IEC 17025 and IEC 62321-8:2021 requirements.
Key Features
- Integrated pyrolysis module with programmable temperature ramping (up to 1000 °C) and inert gas purging, ensuring complete and repeatable thermal decomposition of polymer samples.
- Dedicated single quadrupole mass spectrometer optimized for unit-mass resolution scanning at up to 20,000 u/s—enabling full-scan acquisition across the 1.5–1090 u range within sub-second dwell times.
- Pre-configured RoHS screening method library with automated peak detection, retention time alignment, and threshold-based pass/fail flagging for all seven regulated phthalates.
- Built-in maintenance wizards for ion source cleaning, detector tuning, and vacuum system diagnostics—reducing downtime and minimizing operator dependency on service engineers.
- Compliance-ready instrument control software with audit trail functionality, user access levels, and electronic signature support aligned with FDA 21 CFR Part 11 and GLP/GMP data integrity principles.
Sample Compatibility & Compliance
The Py-Screener accepts solid polymer samples weighing 0.1–2.0 mg, including PVC-insulated wires, ABS casings, silicone gaskets, and thermoplastic elastomers. Its pyrolytic interface eliminates matrix interference from fillers, plasticizers, and stabilizers common in electronics-grade plastics. The system meets the performance criteria outlined in IEC 62321-8:2021 for screening-level analysis of phthalates in electrotechnical products. All calibration and verification protocols are traceable to NIST-traceable reference materials; the included certified phthalate standard set—developed in collaboration with SGS—is the only commercially available RoHS-compliant standard series validated for Py-GC/MS workflows, featuring three concentration levels (blank, 100 mg/kg, 1000 mg/kg) across six certified reference disks (including twelve blank disks for background assessment).
Software & Data Management
Shimadzu’s LabSolutions Insight software provides intuitive workflow-driven operation—from method setup and auto-tuning to report generation and result archiving. Raw data files (.qgd) are stored with embedded metadata (operator ID, instrument serial, timestamp, pyrolysis parameters). The software supports customizable reporting templates compliant with IEC 62321-8 Annex B, including summary tables with detected concentrations, uncertainty estimates, and regulatory status indicators (e.g., “Below Threshold”, “Requires Confirmation”, “Exceeds Limit”). All data modifications are logged in an immutable audit trail with time-stamped entries, satisfying ISO/IEC 17025 clause 7.5.2 and EU MDR Annex II requirements for analytical data traceability.
Applications
- Routine screening of phthalate content in incoming raw materials (e.g., PVC granules, cable sheathing compounds) prior to assembly.
- Production line QC verification for RoHS-conformant batches in electronics OEM and EMS facilities.
- Third-party conformity assessment per EN 62321-8 and China RoHS GB/T 26572–2011.
- Root cause analysis of non-compliant lots through retrospective data mining and spectral library matching.
- Method development support for laboratories transitioning from HPLC-UV or GC-FID to confirmatory GC-MS analysis.
FAQ
Does the Py-Screener require derivatization or solvent extraction prior to analysis?
No. The system uses direct pyrolysis-GC/MS, eliminating all wet chemistry steps and reducing sample turnaround time to under 8 minutes per test.
Can the Py-Screener quantify phthalates beyond screening thresholds?
It provides semi-quantitative results calibrated against certified reference standards; for definitive quantification, follow-up analysis using validated GC-MS methods per IEC 62321-4 is recommended.
Is the instrument compatible with existing Shimadzu GC-MS infrastructure?
Yes—the Py-Screener shares the same mass spectrometer platform and software architecture as the GCMS-QP2020 NX series, enabling seamless integration into multi-instrument labs.
What regulatory documentation is provided with the system?
Each unit ships with a Factory Acceptance Test (FAT) report, IQ/OQ documentation templates, and a RoHS-specific validation protocol aligned with ISO/IEC 17025 Clause 5.4.5.
How often does the pyrolyzer require maintenance?
Under typical use (≤20 samples/day), the quartz pyrolysis tube requires replacement every 6–12 months; routine cleaning of the transfer line is guided by the onboard maintenance wizard every 50 runs.
