Operating Company; Method And Process Validation; User Qualification - tecan MagicPrep NGS Operating Manual

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Risk of incorrect measuring results. After system care or maintenance has been performed,
operation must only be resumed after the correct system operating conditions have been
verified.
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Always use recommended reagent kits within expiration date to assure good system
performance and reliability.
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Always wear protective clothing according to GLP.
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Heavy load! Use two people to lift the instrument.
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Fire hazard caused by flammable liquids or system liquids.
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Avoid the formation and accumulation of flammable vapours.
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For California residents only: This product can expose you to chemicals such as lead which
is known to the State of California to cause cancer and birth defects or other reproductive
harm. For more information go to www.P65Warnings.ca.gov/product.
2.3

Operating Company

The operating company must ensure that the MagicPrep NGS instrument and in
particular the safety features, function properly and that all the personnel in
contact with the instrument are adequately trained.
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Responsibilities 
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2.4

Method and Process Validation

While performing method and process validation, pay attention to the following.

Responsibility

of the Key
Operator
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2.5

User Qualification

The laboratory personnel must be fully qualified and trained to operate the MagicPrep NGS
instrument. The work described in this Operating Manual must only be performed by authorized
personnel with the qualifications prescribed below.
Laboratory personnel must:

have suitable technical training

be familiar with the laboratory safety regulations and directives

be familiar with the instructions for the safety elements of the instrument
M01534_v1.1 MagicPrep NGS Instrument Operating Manual
Method and process validation
Defining the installation has been completed
Ensuring that all people in contact with the MagicPrep NGS are adequately
trained
Ensuring the availability of appropriate protective clothing and equipment
Ensuring the maintenance and safe operation of the MagicPrep NGS
instrument.
Requiring adherence to laboratory safety regulations and directives.
Only use Tecan Revelo MagicPrep NGS Reagent Kits.
Check that the pipette used to dispense the sample and magnetic beads
meets the accuracy and precision requirements for the process or workflow.
Remove completed library samples from the MagicPrep NGS instrument
within 65 hrs. of the preparation being completed.
Operating Manual
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