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可靠的结果始于可控的药物回收

如果以人工方式从撞击器、DUSA采集管和其他测试组件中回收药物,可能会引入可变性,从而影响数据质量。

样品回收系统™ SRS 100i可自动完成这一关键工序的重要环节,从而实现可控、可重复的样品回收。

凭借清晰的自动化工作流程,系统能够在DDU和APSD工作流程中保证样品制备的一致性,生成可直接用于HPLC分析的样品。

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SRS 100i:实际应用中的自动药物回收

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关键特性:SRS 100i

在不同分析人员和实验室之间保证药物回收的可重复性

可控的溶剂分配和溶解

减少人工操作和实际回收时间

样品可直接用于HPLC分析

经配置可适应大多数实验室工作流程

消除交叉污染风险

契合既定回收方法

针对受监管环境 (21 CFR Part 11和GMP) 设计

Drug Recovery for DDU and APSD in Four Steps

1. 装载

将测试组件置于系统内的专用支架中。

2. 分配

将指定体积的溶剂输送至每个组件和采集表面。

3. 溶解

控制溶剂输送和冲洗,确保使用既定方法实现药物回收一致性。

4. 收集

将制备好的样品吸入HPLC小瓶中,直接用于分析。

Sample Recovery System™ SRS 100i Technical Specifications

Dispensing accuracy

± 1%

Agitation Speed

10-60 RPM (±1 RPM)

Run Time

Up to 24 hours

(up to 60,000 revolutions)

Connectivity

USB A, USB B, RS 232 (run in digital input)

Dimensions (w x d x h)

1250 x 605 x 605 mm

兼容Inhalytix®+

  • 方法和操作参数均可导入Inhalytix+
  • 支持统一、可追溯的APSD测量工作流程
  • 减少人工数据处理,提高数据一致性
  • 下游生成的HPLC结果可导入Inhalytix+,用于完善数据集

进一步了解Inhalytix+

Frequently Asked Questions: Automated Drug Recovery

Explore our most frequently asked questions about our Sample Recovery System™ SRS 100i and drug recovery, covering implementation, use and regulatory compliance.

Why automate drug recovery in inhaler testing?

Manual drug recovery relies on operator technique, which can introduce variability. Automated drug recovery standardises key steps, supporting controlled, repeatable execution and improving confidence in results.

How does the SRS 100i improve reproducibility?

The SRS 100i controls key variables in the recovery process, including solvent, dispensing, dissolution and sample collection. By replacing manual intervention with a defined, repeatable workflow, it delivers consistent execution across runs, analysts and sites.

Can the SRS 100i be used for DDU and APSD workflows?

Yes. The SRS 100i supports drug recovery for both Delivered Dose Uniformity (DDU) testing and Aerodynamic Particle Size Distribution (APSD) measurement, working with standard components such as DUSA systems, impactors and associated components including induction ports and preseparators.

Can the SRS 100i be used within our existing inhaler testing workflows?

The SRS 100i is designed to closely align with established manual recovery approaches. By replicating key steps within a controlled, automated workflow, it supports a straightforward transition from manual to automated methods while maintaining consistency in sample handling.

How does the system support data integrity?

By standardising solvent delivery, dissolution and sample handling, the SRS 100i reduces operator-dependent variation and supports consistent, traceable execution of recovery processes. Additionally, Inhalytix®+ compatibility enables the transfer of method parameters and operational data into a unified platform, supporting complete, traceable datasets and helping to generate robust and defensible results.

Does the SRS 100i support regulatory compliance?

The SRS 100i supports use in regulated environments by standardising key stages of the drug recovery process, including solvent dispensing, dissolution and sample handling. This controlled, repeatable approach reduces operator-dependent variation, while built-in electronic records functionality supports data integrity and traceability in line with regulatory requirements, including 21 CFR Part 11 and GMP.

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