Huironhe HRH-XY2060 Automated Drug Washing Station for NGI Component Recovery
| Brand | Huironhe |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Region of Manufacture | Domestic (China) |
| Model | HRH-XY2060 |
| Price | USD 1 (Quotation upon Request) |
Overview
The Huironhe HRH-XY2060 Automated Drug Washing Station is a precision-engineered auxiliary device designed specifically for pharmaceutical aerodynamic particle size distribution (APSD) testing using the Next Generation Impactor (NGI). It performs controlled, reproducible solvent-based recovery of active pharmaceutical ingredients (APIs) deposited on NGI internal components—including the induction port (artificial throat) and pre-separator—prior to high-performance liquid chromatography (HPLC) or other quantitative analytical methods. Unlike manual rinsing protocols, the HRH-XY2060 implements programmable rotational agitation under defined mechanical parameters (speed, duration, oscillation angle), ensuring uniform solvent contact and minimizing operator-induced variability. Its design adheres to the fundamental principles of extractive recovery validation outlined in USP , ISO 27427:2013, and FDA Guidance for Industry on “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products: Quality Considerations,” supporting GLP-compliant data generation in inhalation product development and QC laboratories.
Key Features
- Modular component compatibility: Standard configuration supports simultaneous washing of one NGI artificial throat and one pre-separator; optional configurations allow dual-throat or dual-pre-separator operation.
- Precision rotational agitation system with adjustable speed (rpm), cycle count, and dwell time—enabling method optimization across diverse API solubilities and formulation matrices.
- Compact benchtop footprint (W × D × H: 320 × 380 × 260 mm) with rigid aluminum alloy chassis for vibration-damped operation and long-term mechanical stability.
- Intuitive LED touchscreen interface with password-protected parameter locking, real-time status feedback, and non-volatile memory for up to 20 user-defined washing protocols.
- Optional side-mounted polycarbonate safety shields—certified to EN 60529 IP20—prevent accidental contact during operation and mitigate risk of foreign object ingress into moving mechanisms.
- Calibration traceability support: Built-in timer accuracy ±0.5 s per hour; rotational speed repeatability ±1 rpm over full operating range.
Sample Compatibility & Compliance
The HRH-XY2060 accommodates standard NGI components manufactured by Copley Scientific (UK) and similar ISO 27427-compliant impactors. It supports common extraction solvents including methanol, isopropanol, ethanol/water mixtures, and phosphate-buffered saline (PBS), with temperature-stable operation from 15–30 °C ambient. All wetted parts are constructed from chemically resistant PTFE-coated stainless steel and borosilicate glass—validated for non-reactivity with corticosteroids, beta-agonists, and anticholinergic APIs. The device meets electrical safety requirements per GB 4793.1–2019 (equivalent to IEC 61010-1) and is compatible with laboratory quality management systems requiring audit trails and change control per FDA 21 CFR Part 11 (when integrated with compliant LIMS or ELN platforms).
Software & Data Management
While the HRH-XY2060 operates as a standalone instrument with embedded firmware, its protocol logs—including date/time stamp, selected method ID, run duration, and completion status—are exportable via USB 2.0 to CSV format. For regulated environments, optional RS-232 or Ethernet connectivity enables integration with electronic lab notebooks (ELNs) or laboratory information management systems (LIMS) to support full traceability, electronic signature workflows, and automated report generation. All parameter modifications are recorded with user ID and timestamp, satisfying ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Recovery of dose-uniformity samples from NGI stages during DPI and MDI product development.
- Method qualification and robustness testing per ICH Q2(R2) guidelines for extractive efficiency and process repeatability.
- Supporting regulatory submissions requiring demonstration of consistent drug recovery across multiple operators and batches.
- Facilitating comparative dissolution studies between different inhaler devices or formulation variants.
- Enabling routine QC release testing where NGI-based APSD assessment is mandated by pharmacopoeial monographs (e.g., USP , Ph. Eur. 2.9.18).
FAQ
Is the HRH-XY2060 compatible with non-Copley NGI systems?
Yes—it accepts any NGI artificial throat or pre-separator conforming to ISO 27427:2013 dimensional specifications (outer diameter ≤ 38 mm, height ≤ 120 mm). Custom adapter plates are available upon request.
Can washing parameters be validated and documented per GMP requirements?
Yes. Full parameter logging, user access controls, and exportable audit trails enable IQ/OQ/PQ documentation. A validation support package—including test protocols and blank templates—is provided with each unit.
What maintenance is required for long-term operational reliability?
Routine cleaning of solvent-contact surfaces and annual verification of rotational speed calibration using an external tachometer are recommended. No lubrication or internal servicing is required within the first 5 years of operation.
Does the device support multi-solvent sequential washing?
No—the HRH-XY2060 is optimized for single-solvent, single-cycle recovery. Sequential washing requires manual solvent exchange between runs, which remains within standard NGI recovery SOPs.
