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Download: Cedex 2 Software brochure (976KB)Cedex
System Suitability Test - Principle and Components
The System Suitability Test (SST) is an important process that is generally set up after the actual instrument qualification phase of a process validation is completed. The SST makes use of the results and experiences from the instrument qualification phase to establish a plan for verifying, on a regular basis, that the quality of the instrument matches the condition it was in during the qualification phase. The SST is defined by the user and can be created with the use of several components known as checkpoints. A defined checkpoint can involve either a defined set of measurements or a set of actions (such as visual checks) that should be carried out.
The SST is part of quality assurance that must be implemented in the cGMP area. In addition to routine scrutiny of the instrument, the SST must create evidence that the system complies with all requirements for proper operation with regard to the critical parameters related to the analysis method.
Innovatis offers innovative tools to manage a SST for the Cedex and Cedex HiRes
Both systems feature on-board cleaning and maintenance routines as standard equipment. These programs can be scheduled to run automatically, either at a certain time or after a certain number of events. Regular use of these routines help maintain and secure the precision of the system.. Recommendations about the frequency of the procedures and how to run them are specified in the manual and in the laboratory textbook "Cedex Cleaning & Maintenance SOP′s", which is available for free.
Density Reference Standard Beads (DRSB) are used for system calibration. This particle size standard, with a defined number of particles per ml, is traceable to the standard of the Physikalisch -Technischen Bundesanstalt in Braunschweig and is produced according to GMP guidelines. Equipment provided by innovatis is already calibrated and has an accuracy of ± < 5%. Consequently, it is not necessary to calibrate a Cedex system when the system is installed. However, the DRSB enables the user to review and record the accuracy and precision of the system in a highly specific way at any time after the initial set-up. The calibration method is a one-point calibration using 1x106 beads per ml. Typically a five-fold repetition is used to obtain a mean value, which is compared to the nominal value for the test bead solution noted on the certificate of analysis. The acceptance range is ± 5% of the nominal value of the beads. Calibration frequency depends strongly on throughput and QA requirements. Consequently, recommendations may vary for individual customers and locations.
Control Beads are used to check the accuracy of the cell concentration results on a daily basis. They are available in three different concentrations so that the linearity of results can also be checked. Regular use of inexpensive control beads allows a for permanent documentation of system integrity as well as for the early initiation of prompt counter-measures, such as thorough cleaning of the system, as soon as minor deviations appear.
Results from measurements with Density Reference Standard Beads and Control Beads can be easily monitored via the SST Trending Chart, which is integrated into the Cedex 2 software. The results of the measurements over time, as well as the placement of the results within user-defined upper and lower limits, are graphically displayed in order to help the user track results over time and define future SST checkpoints. Irregularities in measurement results can be detected through so-called "Trending", which provides the possibility for early detection and correction of potential errors.
For control and documentation purposes, the core of each Cedex system - the flow chamber - can be optically inspected with the Chamber Monitor. A keystroke is sufficient, and within seconds the user may assure himself of the integrity of flow chamber and inlet in the case of the Cedex, and of the complete chamber including outlet in the case of Cedex HiRes. We have designed this process to be fast and easy so that an inspection prior to every use can easily be integrated into the measuring / analyzing procedure. An image of the chamber and inlet may be saved for archiving and documentation purposes.
All Cedex HiRes systems are equipped with a feature for monitoring the chamber. The Chamber Monitor is available for the Cedex Standard system as optional equipment. Naturally, older Cedex Standard systems can be upgraded quickly and in a cost-efficient manner by our service team on site.