RCZ-QY12 Automatic Sampling System – High-Throughput Dissolution Sampling Solution

Dissolution Instruments

RCZ-QY12 Automatic Sampling System

The RCZ-QY12 is a high-capacity automatic sampling system built for pharmaceutical testing labs requiring frequent sample collection. It enhances dissolution tester performance by providing timed, consistent sampling capabilities. This system improves productivity in drug dissolution testing and integrates seamlessly with our pharmaceutical testing instruments.

Description

The RCZ-QY12 Automatic Sampling System is a state-of-the-art solution for high-precision pharmaceutical dissolution testing. Designed for compliance with the latest standards of the Chinese Pharmacopoeia and the mechanical validation guidelines for dissolution testers, this advanced system integrates 12-channel sampling capabilities with robust data integrity features to ensure accuracy, reliability, and operational efficiency.

Product Features:

1. Advanced Data Management

   •  Built-in three-tier user permissions ensure secure operations and audit trails.

   •  USB connectivity supports direct data reporting.

   •  Frequently used data and sampling solutions can be stored for convenient reuse.

 

2. Precision and Temperature Control

   •  Independent real-time temperature control for each dissolution cup with dual-layer protection.

   •  Preheating function ensures system readiness with user-defined start times.

 

3. Automated and Modular Design

   •  Supports both manual and automatic drug addition and sampling.

   •  Modular components allow quick and easy replacements.

 

4. Enhanced Sampling System

   •  Separate sampling and tray systems avoid contamination.

   •  Magnetic pump and advanced circulation pipelines ensure high efficiency.

   •  Automatic cleaning of sampling heads and pipelines minimizes residue and enhances precision.

 

5. Compliance and Certification

   •  Fully compliant with Chinese and international pharmacopoeia standards.

   •  IQ/OQ certification documentation available.

 

Dissolution Parameters:

   •  Channels: 12 channels

   •  Swing Radius Consistency: ≤0.5mm

   •  Rotation Speed Consistency: ≤1.0mm

   •  Difference Between Rotation and Axial Deviation: ≤1.0mm

   •  Speed Range: 10-300RPM

   •  Stability of Rotation Speed: ≤1%

   •  Adjustment Range: Room temperature to 45.0°C

   •  Temperature Uniformity: 0.1°C

   •  Temperature Accuracy: ±0.3°C

   •  Power Supply: AC220V±10% 50Hz

 

Sampling System Parameters:

   •  Channels: 12 channels

   •  Cycle Time: ≤15 seconds

   •  Sampling Time Precision: ≤999.9h/59min59s

   •  Sampling Volume: <10ml

   •  Return Volume: <1%, tube length within 10ml considered standard

   •  Interval: First interval 2-5 minutes, subsequent determined by settings

   •  Sample Storage Capacity: 180 vials

   •  Power Supply: AC220V±10% 50Hz

Note: Our lab instruments support basic audit trails strictly per USP/ChP standards.

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Frequently Asked Questions

Q: What pharmacopoeial standard governs dissolution testing?

A: Dissolution testing is governed by USP <711> (United States Pharmacopeia), ChP 0931 (Chinese Pharmacopoeia), and Ph.Eur. 2.9.3 (European Pharmacopoeia). All Huanghai RCZ-series dissolution testers are designed to comply with USP <711> paddle and basket methods, meeting the ±0.5 rpm speed tolerance and ±0.5°C temperature control requirements. For international market access, verify which pharmacopoeia your target regulatory body recognizes.

Q: How many dissolution channels do I need for a QC lab?

A: Channel selection depends on your batch size and testing throughput. A 6-channel tester (RCZ-6N) suits small-volume labs running one formulation at a time. An 8-channel tester (RCZ-8A) accommodates USP <711> 6-vessel runs with 2 spares. A 12-channel tester (RCZ-12A) is ideal for high-throughput labs running two products simultaneously. As a rule: choose at minimum 8 channels for routine QC; upgrade to 12 if you have more than 3 active products in QC testing. Contact us for pricing.

Q: What is the difference between syringe pump and peristaltic pump in automated sampling?

A: Syringe pumps (used in Huanghai RCZ-QY series) deliver precise, pulsation-free sample withdrawal—critical for viscous media or flow-sensitive APIs. Peristaltic pumps are lower cost but introduce pulsation artifacts that can affect UV absorbance readings in inline detection. For validated methods submitted to regulatory agencies, syringe-pump systems such as the RCZ-QY12 are preferred because they demonstrate superior reproducibility in audit-trail-backed data.

Q: Does the dissolution tester support FDA 21 CFR Part 11 compliance?

A: Huanghai intelligent dissolution testers (RCZ-8N, RCZ-12A, RCZ-QY series) include audit trail functionality—timestamped records of all parameter changes and operator actions—meeting basic USP and ChP audit trail requirements. However, they are not certified as fully 21 CFR Part 11 compliant because certain parameters remain modifiable for R&D flexibility. For FDA-regulated QC environments, pair the instrument with a validated LIMS or laboratory software stack to achieve full Part 11 compliance. Contact us to discuss compliance configuration for your specific regulatory submission.

Q: How often should dissolution media be degassed before testing?

A: USP <711> recommends degassing dissolution media immediately before use to remove dissolved oxygen that can cause bubble formation on tablet surfaces—leading to false-low dissolution results. Best practice: degas each media batch within 30 minutes of testing. The HTQ-1A Vacuum Degasser processes up to 25 liters in a single cycle using vacuum + UV sterilization, eliminating microbial contamination risk. For labs running 8–12 channel testers, a dedicated degasser prevents throughput bottlenecks between runs.