TANDEM — 在线片剂检测
发布时间:2013-05-07作者:浏览次数:844次

在线 PAT 片剂分析工具

TANDEM 是一个全自动的、在线 PAT 工具,允许收集加工数据和控制片剂压缩流程。该系统可提供制药片剂的物理和化学信息。

 

  • 提供药片的物理性质(重量、厚度、直径、硬度)
  • 含量均匀度分析;同步量化多种成分,例如 API 及含水量
  • 满足 IQ/OQ/PQ 以及 USP/EP 标准
  • IP65 等级,适用于定位清洗 (CIP)

 

监管机构要求准确分析药物成品,以确认产品的含量均匀度和物理特征。

传统的含量均匀度分析一般采用液相色谱法离线进行。这个过程比较费时,需要许多操作员,并需要在生产批次和连续的实验室分析中定期手动采集样品药片。近红外传输光谱分析技术可以保证可靠、快速及无损的检测药片含量均匀度,以及分析水分和赋形剂,成为传统方法的替代者。

TANDEM 是市场上的领先技术,经 FDA 批准可以实时放行 (RTR)。

TANDEM 是一个在线制药片剂分析工具,包括 Dr. Schleuniger 10X 传统片剂测试系统和布鲁克 MATRIX 傅立叶变换近红外光谱仪。

 

IP 65 protection

 

TANDEM is protected against dust and water (IP65), allowing decontamination with water or recommended solvents. The mechanical construction of the TANDEM allows rapid and efficient cleaning. Dismantling and reassembling of component modules fitted on the system is fast and uncomplicated. The TANDEM performs well in the most severe production conditions and is ideally suited for installation in an isolator.

Automatic and accurate tablet positioning under the NIR transmission detector head for highest reproducibility.

 

Software

Bruker provides seamless integration of the TANDEM to the tablet press, utilizing the TabStatProTM software along with Bruker’s OPUS data collection and evaluation software. Measurement cycles can be pre-configured for certain tablet products. The setup parameter and analysis results are stored in a database. With an OPC interface, analysis parameters can be transfered real-time to other process software platforms, such as the Siemens SIPATTM.

 

Validation

Complete instrument and software validation including:

  • Full 21 CFR Part 11 compliance
  • Full GMP compliance
  • Full IQ/OQ/PQ support

 

Hassle-free maintenance

TANDEM is designed to be easily maintained by the user, e.g. exchange of NIR light source or tablet holders on product change. Permanent online diagnostics monitor the instrument and advise the user of a failing component.

Instrument performance is validated at a click of a button using Bruker’s Instrument Test Software in conjunction with the built-in Internal Validation Unit, assuring proper operation of the entire system. The instrument can be serviced quickly and will be back in operation with a minimal disruption of the manufacturing process.

 

Bruker - the PAT Leader

Bruker offers the industry’s most comprehensive range of solutions based on vibrational spectroscopy for the FDA Process Analytical Technologies (PAT) initiative:

  • MPA At-line Method Development FT-NIR Spectrometer
  • MATRIX-F Process FT-NIR Spectrometer
  • MATRIX-MF FT-IR Spectrometer for Reaction Monitoring

 

 

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