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      • 雾化吸入剂的DDU递送剂量均一性测试
      • 混悬液水雾喷雾剂吸入制剂(ADI)的DDU递送剂量均一性测试
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      • 雾化吸入剂的空气动力学粒径分布
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      • 加快空气动力学粒径分布测试的省工工具
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      • Inhalytix®
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  • 吸入制剂试验
    • 递送剂量均一性(DDU)
      • 定量吸入气雾剂(MDI)递送剂量均一性测试(DDU)
      • 干粉吸入剂(DPI)的DDU递送剂量均一性测试
      • 雾化吸入剂的DDU递送剂量均一性测试
      • 混悬液水雾喷雾剂吸入制剂(ADI)的DDU递送剂量均一性测试
      • 鼻用产品的DDU递送剂量均一性测试
    • 配件
      • 呼吸模拟器
      • 流量控制器
      • 流量计
      • 真空泵
      • 环境控制
      • NGI散热器
      • 吸入器测试工作站 (ITW)
      • 玻璃膨胀室
      • 喉舌和鼻托适配器
    • 特殊应用
      • 冲击器缩写 (AIM)
      • 美国药典专著(仿制药开发)
    • 空气动力学粒径分布(APSD)
      • 定量吸入气雾剂(MDI)空气动力学粒径分布(APSD)
      • 干粉吸入剂(DPI)的APSD空气动力学粒径分布
      • 雾化吸入剂的空气动力学粒径分布
      • 水雾喷雾吸入制剂(ADI)的APSD
      • 鼻用产品的APSD
    • 改善IVIVC
      • 用于DDU和APSD的IVIVC测试系统
      • 吸入药物溶出度
      • 面罩测试
      • 形态学
      • 冷媒效应
    • 半自动化
      • 半自动 – MDI振摇与喷射系统
      • 加快递送剂量均一性测试的省工工具
      • 加快空气动力学粒径分布测试的省工工具
    • APSD数据分析软件
      • Inhalytix®
  • 药物测试
    • 片剂崩解时限测试
      • DTGi系列
    • 片剂硬度测试(断裂力)
      • 片剂硬度计:TBF 100i
      • 片剂硬度计:TH3
    • 栓剂测试
      • 栓剂融变时限试验:SDT 1000
      • 阴道片融变时限测试仪:VTT
    • 片剂溶出度测试
      • DISi系列
    • 粉末测试
      • 振实密度:JVi系列
      • 堆密度:斯科特体积计
      • 流动性:BEP2
    • 片剂厚度测试
      • 547型片剂厚度仪
      • 700型片剂厚度仪
      • 500型数字卡尺
    • 片剂脆度测试
      • Friabimat:包衣片剂
      • FRVi系列:未包衣片剂
    • 半固体测试
      • 立式扩散池测试仪:HDT 1000
      • 立式扩散池测试仪:HDT 1
  • 洗涤剂试验
    • 清洁剂测试仪
      • 清洁剂测试仪: TRG 800i
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Go back to News & Events

State-of-the-art manufacturing gives Copley Scientific’s new dissolution tester the edge in enhanced mechanical calibration

21 April 2010; Nottingham, UK: Copley Scientific has launched the Dissolution Tester DIS-EMC, a new system that features Enhanced Mechanical Calibration, and which is designed to meet the latest and most rigorous calibration needs in this field. State-of-the-art manufacturing procedures bring new standards in controlling the tolerances and dimensions of the critical elements of the Test Station in which the dosage form resides. In line with current regulatory guidance, this significantly reduces the potential of the dissolution tester to contribute to testing variability.

While accepted practice in the pharmaceutical industry has been to calibrate dissolution testers using a combination of mechanical checks and performance verification tablets, there is concern about the wide acceptance ranges and variability these generate. As a result the move is towards enhanced mechanical calibration as an alternative, or at least as a precursor, to chemical calibration. In January 2010 the FDA issued guidance on “The use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)”.

Enhanced mechanical calibration requires strict control of the dimensions of, and the spatial relationships between, critical elements of the dissolution tester. Copley Scientific has identified these critical elements to be the dissolution vessel and lid, and the stirring element. Controlling these, while also maintaining stirring speed and media composition and temperature within tight limits, minimises any instrument contribution to test method variability.

It has long been recognised that dissolution vessel dimensions and irregularities are a major factor in results variability. Using vacuum forming techniques, Copley Scientific has produced a vessel with superior dimensions and which has provided a platform for the development of a new lid and stirring element. This production method guarantees an internal diameter tolerance and blemishfree spherical radius of +/- 0.13 mm (compared with the traditional unit’s +/- 2 mm). Friction-free bearings in the lid and a precision-ground shaft for the stirring element have enabled a 50% reduction in tolerances relating to wobble, verticality and centering. The Dissolution Tester DISEMC betters the dimensional tolerances specified by the FDA by a factor of 2.

The ‘audit-proof’ Copley Scientific Dissolution Tester DIS-EMC provides the highest standards in dissolution testing equipment. In addition, existing users of Copley DIS 6000 and DIS 8000 Dissolution Testers can upgrade to the new DIS-EMC Tester specification by exchanging their standard Test Station for the new EMC Test Station. www.copleyscientific.com

CAPTION: The Test Station of the Copley Scientific Dissolution Tester DIS-EMC

 

About Copley Scientific

Copley Scientific is recognised as the world’s leading manufacturer of inhaler test equipment and is a major supplier of test equipment for pharmaceutical solid dosage forms, including tablet dissolution, disintegration, friability, hardness and powder testers. The company has offices in the UK and Switzerland and a partnership with aerosol particle science experts MSP Corporation in North America. Copley’s broad range of testing products for metered-dose inhalers, dry powder inhalers, nebulizers and nasal sprays are supplied and supported worldwide through close relationships with specialist distributors. Serving the pharmaceutical and associated industries, Copley offers an extensive range of equipment for research, development and quality control, as well as full validation and aftersales service, providing a single source for products that meet individual needs. www.copleyscientific.com

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