Chromatography Transition Analysis.

Discover Chromatography Transition Analysis (ChromTA)

Chromatography column integrity testing is a pivotal aspect of pharmaceutical manufacturing, ensuring the reliability and consistency of chromatographic processes. These tests are integral for maintaining the quality and efficacy of pharmaceutical products throughout the manufacturing process.

Chromatography Column Integrity Testing

Chromatography column integrity testing involves a comprehensive evaluation of chromatographic columns to verify their performance and integrity within manufacturing processes. This process typically includes:

  1. Visual Inspection: A thorough visual examination of the column to detect any physical damage, leaks, or irregularities in packing material that may compromise its integrity.
  2. Pressure Testing: Measurement of flow rate, back pressure, and system pressure to ensure consistent and stable column performance during manufacturing operations.
  3. Retention Time Stability: Monitoring the retention times of target compounds or impurities over multiple runs to assess the stability and reproducibility of chromatographic separation.
  4. Peak Symmetry and Resolution: Evaluation of peak shapes, symmetry, and resolution to detect any abnormalities that may indicate column degradation or packing irregularities affecting manufacturing efficiency.
  1. Capacity Testing: Assessment of the column's peak capacity to ensure optimal separation of components and maximum efficiency in manufacturing processes.

Chromatography Transition Analysis

Chromatography transition analysis involves a systematic investigation of chromatographic transitions to identify and address potential issues affecting manufacturing processes. This approach utilizes advanced analytical algorithms to analyze chromatographic data and detect anomalies.

In particular, Peak Shape Variations such as irregular peak shapes, tailing, or broadening observed during manufacturing runs, which may suggest problems with column integrity or chromatographic conditions impacting product are detected.

Employing chromatography transition analysis enables pharmaceutical manufacturers to proactively identify and address column integrity issues, enhancing quality control and assurance.

Transition Analysis

After applying various mathematical algorithms, we can extract several Transition Analysis Parameters from the monitored signals. By tracking these parameters over time and comparing them to a predefined threshold, we can effectively evaluate the integrity of the chromatography column. This approach enables swift and early detection of bed integrity issues and facilitates comprehensive cross-site and cross-product analysis.

Benefits

By harnessing real-time, in-process data collected during each cycle of the purification process, we eliminate the need for additional labor or downtime.

These indispensable tool uphold the highest standards of quality, consistency, and regulatory compliance in manufacturing processes, safeguarding the safety and efficacy of pharmaceutical products for consumers.

Real-Time

Utilizes real-time, in-process data for ongoing monitoring of purification column performance.

Insights

Analyzes every cycle to ensure thorough evaluation of column integrity.

Early & Easy

Facilitates swift and early identification of alterations in bed integrity.

Cross Comparison

Empowers the comparison of data across various products and manufacturing sites for optimization.