Laboratory Installations
and Utilities

Laboratory Installation Qualification

Process Installations and Utilities such as purified water installations or laboratory gas installations (such as argon, helium and nitrogen) have a critical influence on the results of laboratory analyses and the proper operation of laboratory equipment.

The qualification of laboratory installations and utilities is understood as ensuring that the equipment, installations and supporting systems are capable of continuous and stable operation within the specified limits and tolerance.

We do laboratory qualification regarding, among others:

Heating, Ventilation and Air Conditioning (HVAC) – most often in combination with the qualification of cleanrooms and warehouses

Purified Water (PW, HPW)

Water for Injections
(WFI) installations

Compressed gas installations (laboratory gasses)

Steam installations
(for stability chambers, HVAC)

Sample Project

Subject

A laboratory gas installation
– synthetic air, argon, helium, nitrogen.

Scope

The scope of qualification included: a pressure reduction station with cylinder connection panels, a distribution installation – a separate one for each gas, procedures – cylinder connection.

During the qualification process, the DQ was conducted with the system designer while the IQ and OQ with the supplier. At the OQ stage, the cylinder connection procedure was tested.

Results of implementation

Given the existing technical capabilities (no possibility to test the parameters of the gases), the Process Qualification (PQ) was performed with a limited scope and consisted of verification of the supplier audit results and of the certificate provided by the supplier.

When PQ was completed, the final Qualification Report was produced, summarising all the qualification work.

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