QW-6 Multifunctional Soil Removal Tester by Langbo Instruments
| Brand | Langbo Instruments |
|---|---|
| Model | QW-6 |
| Origin | Jiangsu, China |
| Equipment Type | Laboratory Bottle Washer / Cleaning Validation Tester |
| Temperature Control Range | Ambient to 8°C |
| Rotational Speed Range | 0–200 rpm |
| Timer Range | 0–59 h 59 min |
| Control System | Microprocessor-Based Programmable Logic Controller (PLC) with Digital Interface |
Overview
The QW-6 Multifunctional Soil Removal Tester is a purpose-engineered laboratory instrument designed for standardized evaluation of cleaning efficacy in pharmaceutical, biotechnology, and medical device manufacturing environments. It operates on the principle of controlled mechanical agitation combined with precisely regulated low-temperature aqueous immersion—mimicking critical stages of automated bottle washing, vial rinsing, and component cleaning validation protocols. Unlike general-purpose lab washers, the QW-6 integrates programmable rotational motion (0–200 rpm), sub-ambient temperature control (down to 8°C), and extended timing capability (up to 59 hours 59 minutes) to replicate worst-case cleaning conditions required for residue challenge studies, such as those involving proteinaceous, oily, or viscous soil matrices. Its architecture supports reproducible, operator-independent test cycles essential for cleaning process development, qualification (IQ/OQ/PQ), and routine verification per ICH Q5A, ASTM E2573, and ISO 15883-1 guidance.
Key Features
- Microprocessor-controlled PLC system enabling fully customizable cleaning cycles—including ramped speed profiles, multi-step temperature hold sequences, and staggered timer activation.
- Stainless steel chamber with insulated jacket and Peltier-based cooling module, ensuring stable temperature maintenance from ambient down to 8°C without external chiller dependency.
- Variable-speed rotating platform (0–200 rpm) with reversible direction and torque-sensing feedback, compatible with standard ISO 8536-4 compliant glass vials, HDPE/PP bottles (10–500 mL), and stainless-steel coupons mounted on custom carriers.
- Digital touchscreen interface with password-protected user levels (Operator, Technician, Administrator), supporting cycle recall, parameter locking, and real-time status logging.
- Integrated safety interlocks including lid-open detection, overtemperature cutoff, and motor stall protection—compliant with EN 61000-6-2 (EMC) and EN 61010-1 (Safety).
Sample Compatibility & Compliance
The QW-6 accommodates a broad range of sample formats used in cleaning validation: calibrated soil-coated stainless-steel coupons (per ASTM E2573 Annex A1), filled and sealed vials subjected to simulated washer dwell times, and reusable process equipment inserts. All contact surfaces are electropolished 316L stainless steel, meeting USP material compatibility requirements. The unit supports generation of ALCOA+ data integrity attributes—audit trails, electronic signatures, and immutable cycle records—when operated under validated software configurations aligned with FDA 21 CFR Part 11 and EU Annex 11 expectations. Documentation packages include Factory Acceptance Test (FAT) reports, IQ/OQ templates, and traceable calibration certificates for temperature and rotational sensors.
Software & Data Management
The embedded firmware supports export of raw cycle logs (CSV format) containing timestamped temperature, RPM, elapsed time, and alarm events. Optional PC-based software (Langbo CleanLog™ v3.2) provides advanced analysis tools: comparative soil removal kinetics plotting, statistical process control (SPC) charts for cycle-to-cycle variability, and automated report generation compliant with ISO/IEC 17025 clause 7.8. Data files are encrypted at rest and support role-based access control; all modifications are tracked with full audit trail metadata (user ID, timestamp, before/after values). Software validation documentation—including risk assessment (ICH Q9), traceability matrix, and retest schedule—is supplied with each installation.
Applications
- Development and optimization of cleaning procedures for parenteral drug manufacturing vessels, stoppers, and isolator components.
- Residue recovery studies using spiked model soils (e.g., insulin, casein, soybean oil) on representative substrates per PDA Technical Report No. 29.
- Verification of cleaning agent compatibility and rinse efficiency under cold-wash conditions typical for thermolabile APIs.
- Supporting regulatory submissions requiring evidence of cleaning robustness across equipment lifecycle phases—from design qualification through continued process verification.
- Training laboratories conducting GMP-compliant cleaning validation workshops and internal auditor certification programs.
FAQ
What standards does the QW-6 comply with for cleaning validation studies?
It supports methodologies referenced in ASTM E2573, ISO 15883-1, PDA TR29, and ICH Q5A; its operational parameters align with FDA and EMA expectations for worst-case challenge testing.
Can the QW-6 be integrated into a validated computerized system?
Yes—when paired with Langbo CleanLog™ and configured per 21 CFR Part 11, it delivers electronic records with audit trails, signature authentication, and data integrity safeguards.
Is external refrigeration required to achieve 8°C?
No—the integrated Peltier cooling system maintains stable sub-ambient temperatures without auxiliary chillers or glycol loops.
How is rotational accuracy verified during qualification?
Each unit ships with NIST-traceable calibration data for speed sensor output; users perform periodic verification using an optical tachometer per IQ/OQ protocol.
Does the QW-6 support custom fixture design for non-standard containers?
Yes—Langbo provides engineering consultation and CAD-based fixture development services for specialized sample carriers, subject to mechanical feasibility review.
