EURPING Poseidon-4200-YP GMP-Compliant Laboratory Bottle Washer

Overview

The EURPING Poseidon-4200-YP is a fully programmable, GMP-compliant laboratory bottle washer engineered for high-reliability cleaning and rinsing of glassware, volumetric flasks, pipettes, bioreactor components, and other critical labware in regulated pharmaceutical, biotechnology, and clinical research environments. It operates on a closed-loop, recirculating hot water–detergent–rinse–dry cycle, integrating precision fluid dynamics, temperature-controlled thermal disinfection (up to 93°C), and HEPA-filtered forced-air drying to meet stringent cleanliness validation requirements. Designed in accordance with ISO 15883-1 (washer-disinfectors for medical devices) and aligned with FDA 21 CFR Part 11, EU Annex 1, and WHO TRS 986 guidelines for cleaning process validation, the system supports objective evidence generation for ALCOA+ data integrity principles—ensuring attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available records.

Key Features

• Double-walled 304 stainless steel exterior and electropolished AISI 316L stainless steel interior chamber (Ra ≤ 0.6 µm surface finish) for corrosion resistance and cleanability.
• Side-opening tempered glass door with integrated safety interlock and emergency stop button compliant with IEC 60204-1.
• Siemens S7-1200 PLC control system with 7-inch color HMI touchscreen; stores up to 10 user-defined cleaning cycles (expandable to 20 via configuration).
• Three-tier access control (Operator / Supervisor / Administrator) with password protection and audit trail logging for all parameter changes and cycle executions.
• Real-time fault detection with audible alarm, on-screen alert (including error code, timestamp, and resolution time), and automatic thermal-printed log output.
• Dual peristaltic detergent dosing pumps with adjustable volume delivery and chemical compatibility verification (validated for alkaline and neutral enzymatic formulations).
• GMP-grade piping network: AISI 316L tubing with internal Ra ≤ 0.4 µm finish; side-fed supply to basket rack; full drain capability after each cycle.
• Integrated monitoring suite: dual pressure transducers, flow meter, spray arm rotation sensor, level switches (low/high), and conductivity sensor for final rinse water quality assessment.
• Dual centrifugal blowers (690 m³/h total airflow) with H14 HEPA filtration and differential pressure monitoring for filter integrity verification.

Sample Compatibility & Compliance

The Poseidon-4200-YP accommodates custom-configured wash baskets designed to hold standard and non-standard laboratory vessels—including 1–20 L carboys, serum bottles, filter housings, chromatography columns, and single-use bioprocessing bags (with appropriate support fixtures). All wetted materials comply with USP Class VI and EP 3.1.9 biocompatibility standards. The system meets ISO 13485 design control requirements and supports IQ/OQ/PQ documentation packages. Its conductivity-based final rinse logic ensures rinse water purity meets pharmacopeial limits (e.g., USP , EP 2.2.38), automatically adjusting rinse duration until conductivity falls below user-specified thresholds (e.g., ≤ 1.3 µS/cm at 25°C).

Software & Data Management

The embedded control software provides full electronic record retention, including cycle start/stop timestamps, temperature profiles, pressure curves, detergent consumption logs, and alarm history—all exportable in CSV or PDF format. LIMS integration is achieved via TCP/IP-based handshake protocol (Modbus TCP or OPC UA optional), enabling bidirectional data exchange for sample tracking and batch release workflows. Audit trails are immutable, time-stamped, and compliant with 21 CFR Part 11 requirements—including electronic signatures, role-based permissions, and change impact assessments for firmware updates.

Applications

• Pre-sterilization cleaning of glassware and stainless-steel components prior to autoclaving or depyrogenation.
• Routine decontamination of HPLC vials, autosampler trays, and LC-MS sample introduction systems.
• Removal of proteinaceous, lipid, or particulate residues from cell culture flasks and bioreactor accessories.
• Validation-supporting cleaning processes in QC labs performing residual solvent or active pharmaceutical ingredient (API) testing.
• Automated cleaning of reusable sampling probes and inline sensors used in continuous manufacturing platforms.

FAQ

Does the Poseidon-4200-YP support automated validation protocols for cleaning process qualification?

Yes—it provides configurable cycle parameters, real-time data capture, and full traceability required for Stage 1 (Equipment Qualification), Stage 2 (Operational Qualification), and Stage 3 (Performance Qualification) per ASTM E2500 and PDA Technical Report No. 29.
Can final rinse conductivity thresholds be adjusted by the user?

Yes—thresholds are fully programmable within the HMI interface and can be set independently for multiple rinse stages, with automatic cycle extension if specifications are not met.
Is remote monitoring supported?

Remote status viewing and basic alarm notification are supported via Ethernet-connected SCADA or enterprise MES systems using standard industrial communication protocols.
What maintenance intervals are recommended for the HEPA filters and circulation pump?

HEPA filter replacement is triggered by differential pressure alarms (typically every 6–12 months depending on usage); pump inspection is scheduled every 500 operational hours or annually, whichever occurs first.
Are cleaning validation kits (e.g., residue swabbing ports, thermocouple mapping ports) available as factory options?

Yes—optional validation support packages include calibrated PT100 probe ports, dedicated swab access points, and pre-installed thermocouple routing channels compatible with third-party mapping software.