Process Installation and Utilities

Installation Qualification

Process installations and utilities, such as purified water or compressed air supply installations, require qualifications as they have a serious impact on the quality of the finished product and on proper operation of the manufacturing equipment.

The qualification of process 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 installation 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 (compressed air, nitrogen)

Steam installations
(for manufacturing, for HVAC)

Sample Project

Subject

A Purified Water (PW)
supply installation where the water is produced
by the reverse osmosis and the electro-deionisation method.

Scope

The scope of the qualification included the following components: a raw water preparation station, a purified water production station (RO+EDI), a distribution loop with a buffer tank, a distribution sub-loop for the laboratory, a SCADA monitoring and control system, procedures: sanitization, alert and emergency.

During the qualification process, the design qualification (DQ) was performed with the system designer while the installation qualification (IQ) and the operational qualification (OQ) with the supplier. At the OQ stage, the sanitization procedure was tested.

The process qualification (PQ) was divided into 3 stages, in accordance with the sampling plan and schedule.

During the PQ qualification, the quality of the water was tested in terms of physiochemical and microbiological properties. The tests were conducted on the basis of the monograph for purified water (PW) according to the European Pharmacopoeia.

Results of implementation

At the first stage of the process qualification, purified water was qualified for use in the manufacturing process and at the second stage of qualification, alert and intervention limits were set for individual parameters.

At the third stage of the process qualification, the final Qualification Report was produced.

Following this stage, the set alert and intervention limits were reviewed again and a schedule of preventive sanitization was created.

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