RCZ-QY8 Automatic Sampling System – Dissolution Test Automation Module

Dissolution Instruments

RCZ-QY8 Automatic Sampling System

The RCZ-QY8 is an automatic sampling system designed to streamline dissolution testing in pharmaceutical laboratories. It integrates with dissolution testers to automate the sample collection process, reducing manual errors and improving consistency. Part of our pharmaceutical testing instruments lineup, the RCZ-QY8 supports efficient workflow and accurate drug analysis.

Description

The RCZ-QY8 Automatic Sampling System is an advanced solution integrated with the RCZ-8A Intelligent Dissolution Tester and ZQY-8A Automatic Sampling System. Fully compliant with the latest Chinese Pharmacopoeia and Mechanical Validation Guidelines for Dissolution Testers, this high-performance 8-channel dissolution system ensures precise testing and robust data integrity.

 

Product Features

 

1. Advanced Data Management

   •  Built-in three-tier user permissions, audit trails, and test record management.

   •  USB connectivity supports direct test data export for reporting.

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

 

2. High-Precision Dissolution Control

   •  Real-time temperature control with independent measurements for each dissolution cup.

   •  Dual-layer temperature protection ensures stability and reliability.

   •  Preheating functionality allows users to schedule start times for heating.

 

3. Automated and Modular Design

   •  Supports both manual and automatic drug addition and sampling.

   •  Modular design for sampling components enables quick replacement.

 

4. Optimized Sampling System

   •  Separate sampling and tray systems avoid cross-contamination.

   •  Vapor condensation design minimizes evaporation loss.

   •  Advanced circulation pipeline with professional quick-release connectors.

 

5. Compliance and Certification

   •  Fully compliant with pharmacopoeia standards.

   •  Includes IQ/OQ certification documentation for validation.

 

Dissolution Parameters

 

Parameter Specification

l   Dissolution Channels  8 channels

l   Swing Radius Consistency ≤0.5mm

l   Rotation Speed Deviation ≤1.0mm

l   Axial Deviation   ≤1.0mm

l   Speed Range      10–300 RPM

l   Stability ≤1%

l   Adjustment Range     Room temperature to 45.0°C

l   Temperature Uniformity     0.1°C

l   Control Precision ±0.3°C

l   Power Supply       AC220V±10%, 50Hz

 

Sampling System Parameters

l   Parameter    Specification

l   Sampling Channels    8 channels

l   Cycle Time   ≤15 seconds

l   Sampling Time Precision   ≤999.9h/59min59s

l   Sampling Volume       <10ml

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

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

l   Sample Storage Capacity 120 vials

l   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.