The term Clean Utilities in the pharmaceutical industry covers utilities that have to fulfil regulatory requirements. The most common utility is water, which can be separated into several pharmaceutical grades of purity. Purified water (PW), Highly Purified Water (HPW) and Water for Injection (WFI) are the most widely used. Water quality specifications can be found in the pharmacopaeias, e.g. the US Pharmacopeia.
Clean Utilities for pharmaceutical use also include clean compressed air, clean gasses (like nitrogen and oxygen), clean steam, special organic solvent systems and vacuum systems, all of which are used in the pharmaceutical industry, hospitals and laboratories.
Water purification is carried out for a wide range of purposes. The food industry needs pure water in order to prevent the growth of microorganisms. The computer chip industry needs ultra-pure water in order to avoid ions, especially metallic ions, during production. Laboratories need pure water free of foreign substances, which could potentially affect the outcome of analyses, and the pharmaceutical industry needs pure water for a variety of purposes – everything from cleaning to the use of pure water as an ingredient in finished pharmaceutical products.
Purification is done in several steps. Starting with drinking water the first step is pre-treatment, which is done in order to remove any substance in the water that could damage the purification equipment. Examples of pre-treatment are active carbon filtration, water softening, cartridge filtration and reverse osmosis (RO). Examples of final treatment could be electrical deionisation (EDI), ultrafiltration (UF), and distillation (for production of WFI).
After the purified water has been produced, the distribution requires specially designed systems that focus on specific factors in order to avoid cross-contamination and microbiological growth. Examples of these factors are requirements regarding turbulent flow, avoiding dead legs, sanitary components, the use of correct materials, sanitization methods, etc.
Services provided by Ramboll
At Ramboll we employ experts highly skilled and experienced in Clean Utility systems. Having designed, erected and certified many different systems, we can provide help with the specification of the system (URS), creating the right design, both for brand new systems as well as for the rebuilding of existing systems, and managing the handling of materials on the construction site in order to ensure that the desired quality of the final system is achieved.
When we build a system we need to qualify it in order to provide documented evidence of the system's compliance and the quality of the water. We usually do this in three steps. First we test and qualify the physical installation (IQ). Then we test and qualify the compliance of the control system and the operational functionality of the system (OQ). Finally we test and validate the quality of the clean utility thoroughly (PQ). The highly skilled engineers at Ramboll can be of assistance throughout the qualification process from developing the protocols and test plans to testing and finalising the qualification report.