Laboratory Equipment

Qualification of Laboratory Equipment

The proper operation of laboratory equipment is critical for the assurance of correct results of tests and analyses.

An item of laboratory equipment must be qualified before it is used for analytical tests. The qualification of laboratory equipment is understood as ensuring that the laboratory equipment and supporting systems are capable of continuous and stable operation within the specified limits and tolerance.

We perform the qualification of laboratory equipment with regard to:

Incubators

Sterilisers

Fume hoods

Laminar flow cabinets

Stability chambers

HPLC

Sample Project

Subject

A laminar flow cabinet
with an A clean zone in the surroundings of the B zone.

Scope

The scope of qualification included the following components:

  • air handling unit,
  • filters
  • control and measurement system.

As it was legacy equipment, the DQ was limited to verifying if the equipment was still capable of satisfying the basic legal requirements according to the technical documentation.

Results of implementation

At the IQ stage, the available technical documentation was verified and the correctness of the installation confirmed.

The OQ and PQ qualifications were combined in one stage during which all the measurements concerning air quality and the laminarity of the flow were taken and the control and monitoring system was tested.

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