Tecan QC tools for GxP needs

For IQOQ of Tecan microplate readers

Tecan’s QC tools and installation qualification and operational qualification (IQOQ) documents help customers using Tecan microplate readers to fulfill typical regulatory requirements in an efficient way, eliminating the need to perform error-prone pipetting steps. Combining a single, reuseable solid sample QC plate with dedicated quality control software, these QC tools allow verification of the proper function of major instrument components, as well as key measurement modes. The documented results of these checks form the basis for the IQOQ of your microplate reader.




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Tab 01 / Overview
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Confidence throughout the complete lifecycle

Most laboratories are subject to increasingly strict regulations, such as GLP, CLIA 88, ISO 9001 or ISO 13485, defined by regulatory authorities like the FDA and the EMEA. Tecan’s quality control tools and IQOQ documentation help you to fulfill typical regulatory requirements for your Tecan microplate reader.

Tecan offeres tailormade QC packages for the Sunrise™ and the Infinite® F50 absorbance plate readers, as well as for the Infinite 200® PRO and Spark® families of multimode microplate readers.

Each Tecan quality control package consists of a reuseable QC plate and quality control software, which takes care of all measurements and calculations for the interpretation of results. Simply enter the serial number of the QC plate, put the plate into the microplate reader, and press start.

The QC software provides secure, computer-generated records, with audit trails containing information about who performed what, and when. These records are stored electronically and can be printed if needed.

NIST traceability

For absorbance references on the QC plates

For a high level of quality control, NIST traceability is provided for each absorbance and wavelength reference on Tecan’s QC plates. The reference values can be derived from accepted values of natural physical constants, or be easily traced back to NIST standard 930E with an unbroken chain of comparison.

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Annual recalibration of QC plates

Ensures accuracy and consistency of results

An annual recalibration procedure at Tecan’s factory site ensures the consistency and accuracy of reference values for each QC plate, making certain that these values are still valid, allowing the plate to be used with complete confidence. For documentation purposes, a certificate of calibration is provided for each QC plate.

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Highlights of Tecan’s QC tools include

  • Comprehensive functional checks of key measurement modes integrated on one QC plate for efficient IQOQ procedures
  • No sample preparation or pipetting steps necessary
  • Software-guided workflow helps you get started quickly
  • Set of basic IQOQ documents available from Tecan
  • Results documented in electronic form and printed reports
  • Summary sheet plus detailed measurement results available
  • Periodic recalibration of QC plates ensures consistent results




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Tab 02 / QC for single mode readers
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Comprehensive QC packages for Tecan absorbance plate readers

The QC Pac™ 1 and QC Pac™ 2 packages for the Sunrise™, as well as the MultiCheck™ QC package for the Infinite® F50 microplate reader, are Tecan’s quality control tools for single mode absorbance readers.

These QC packages enable functional checks of the key instrument parameters – such as accuracy, precision and linearity – as well as microplate carrier alignment.

Sunrise customers can choose between two versions of the QC Pac according to their specific requirements. QC Pac 2 offers comprehensive function checks for a typical range up to 1.6 OD, and is therefore often used for the IQOQ of the Sunrise reader.

If an extended test range of up to 2.2 OD is needed, QC Pac 1 can be used, and can even be combined with QC Pac 2 to provide extremely comprehensive functional checks.

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  QC Pac 1 for Sunrise QC Pac 2 for Sunrise MultiCheck for Infinite F50
  QC Pac 1 for Sunrise QC Pac 2 for Sunrise Multicheck for Infinite F50**
Alignment      
 
Wavelength range 200-1,100 nm 340-750 nm 400-750 nm
 
Absorbance < 3.0 OD*
Accuracy      
Precision      
Linearity      
 
Absorbance < 1.6 OD*
Accuracy      
Precision      
Linearity      
 
Absorbance < 0.35 OD*
Accuracy      
Precision      
Linearity      
 
Filter wavelength check      
 

Function included in this reader
* NIST traceable
** tests are using the standard filter configuration of the Infinite F50 reader only
Note: for detailed values please see product description




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Tab 03 / QC for multi-mode readers
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MultiCheck packages for IQOQ of Infinite® 200 PRO and Spark® multimode readers

These packages consist of the MultiCheck Plus QC plate and a reader family-specific version of the MultiCheck quality control software.

They provide a complete solution for periodic functional checks of Tecan’s portfolio of multimode readers. Results are documented in clear and concise reports, simplifying IQOQ of these instruments.

The MultiCheck Plus QC plate is designed as a universal QC plate for the Infinite 200 PRO and Spark families of multimode microplate readers.

It provides functional checks of absorbance, fluorescence and luminescence reading modes, as well as for other key parameters – such as temperature control and shaking – where supported.

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  Infinite 200 PRO series Spark family
Alignment
All measurement modes    
 
Absorbance
Accuracy*    
Linearity    
Precision    
 
Fluorescence
Linearity    
Precision    
Signal/blank    
 
Fluorescence polarization
Precision **   
 
Time-resolved fluorescence
Lag-time check **   
 
Luminescence
Crosstalk    
Lumi-scan    
 
AlphaScreen®
Laser, fiber and IR-sensor check **   
 
FI-monochromator EX/EM wavelength check
Accuracy ***   
Precision ***   
 
Absorbance monochromator wavelength check
Accuracy    
Precision    
 
Temperature control    
 
Injectors
Positioning    
 
Barcode reader ****   
 
Shaking
Linear and orbital shaking    
 
Stacker
Plate processing *****   
 
Cuvette absorbance
Baseline flatness ***   
 

Function included in this reader
* NIST traceable
** Filter-based instruments only
*** Quad4 Monochromators™-based instruments only
**** Using a hand-held barcode scanner
***** in combination with a third-party plate stacker such as the S-LAB™ fom paa