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.
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.
