The System Suitability Test

Cedex systems measure the cell concentration and viability of suspension cell samples, and use image recognition software that recognizes live and dead cells via the Trypan blue exclusion method for the determination of viability. Accurate results can only be achieved when Cedex systems are functioning properly.

The System Suitability Test (SST) is designed to ensure the accuracy of Cedex systems and to allow for comparison of the results from different systems within one location, or different systems spread out over several locations, in order to ensure that all systems deliver comparable results. In addition, the SST is designed to ensure that systems used in production meet cGMP requirements for the proper condition of the equipment based on risk-assessment (see, e.g., 21 CFR 211.68a, b; 21CFR 211.160 (4)).

Elements of the System Suitability Test

Innovatis offers a number of tools for monitoring and ensuring system integrity. In combination, as well as alone, they offer a high measure of security and transparency. The SST is comprised of the following tools:

• Density Reference Standard Beads (DRSB)
  Data sheet (122 KB)
• Cedex Control Beads
  Data sheet (74 KB)
• Cedex HiRes Control Beads
  Data sheet (73 KB)
• Chamber Monitor
  Cedex SST website
• Cedex Reagent Kits and
  refill packs
  Data sheet (74 KB)
• Cedex HiRes Reagent Kits and
  refill packs
  Data sheet (80 KB)
• Viability Beads
  Data sheet (268 KB)

Now available in the Cedex 2 software: SST trending charts
Cedex 2 software brochure
(582 KB)

User Benefits

The System Suitability Test tools allow for the following possibilities and user benefits:

• Cleaning and maintenance routines ensure system integrity. The Reagent Kits, as well as reagent refill packs, are tested and optimized for Cedex systems and are produced under cGMP conditions in order to ensure a high performance level.
• The use of Density Reference Standard Beads facilitates constant monitoring of the accuracy of the measurement.
• Control Beads can be used to check the measurement performance at regular intervals in order to detect changes in the measurement process.
• Viability Beads can be used to monitor the determination of viability carried out by software image analysis algorithms.
• The Chamber Monitor allows for visual inspection of the flow chamber in order to detect impurities in the flow chamber.
• Trends in results from system checks, include beads and reagents checks, can be easily monitored via System Suitability Test trending charts, which are fully-integrated into the Cedex 2 software. Using the trending charts to monitor checks helps ensure traceability, security and reliability of the results.

If you would like to learn more about our System Suitability Test tools and recommendations, please contact innovatis sales at .