Clean Utilities Qualification

Any pharmaceutical production facility requires the presence of clean process utilities, which are either used directly as components of the manufactured medicinal products or serve an auxiliary function during the technological process. Due to their contact with the product, equipment surfaces that come into contact with the product, or the air in cleanrooms, these utilities must meet stringent hygienic standards. The most common clean utilities in pharmaceutical production include:

Clean Compressed Air (Compressed Air, CA)
Purified Water (PW)
Water for Injections (WFI)
Pure Steam (PS) / Clean Steam (CS)
Nitrogen and other process gases

The qualification of generation, storage, and distribution systems for clean utilities is generally similar to the qualification of process equipment. A distinctive feature, however, is the requirement to verify the quality of the provided process utility. As a rule, the following qualification stages are conducted for clean utilities:

Risk Analysis (RA) / Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)

For water treatment systems, a Performance Qualification (PQ) is also conducted, which is divided into stages: PQ1, PQ2, and so on.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.