The access to water has played an important role in shaping the modern world. Evidently, this molecule is also one of the major resources utilized by the pharmaceutical industry. Water can be present as an excipient or might be used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials, etc.
Depending on the pharmaceutical application, different grades of water quality might be required. The European pharmacopoeia provides quality standards for water for injections (WFI), purified water or water for preparation of (herbal) extracts. It stands to reason that different grades of water quality also encompass the difference in the microbiological quality of the water (e.g. no microorganisms should be present in WFI). A well-defined amount of total aerobic microorganisms (TAMC) are tolerated for purified water.
In 2018 the federal agency for medicines and health care products has launched theme control actions to assess the quality of purified water utilized in Belgian hospital and public pharmacies. The by our OMCL obtained results indicated that 90% (17/19) of the samples originating form hospital pharmacies were conform, while 51% (40/79) of the samples originating from public pharmacies were not conform. This action was repeated for the public pharmacies in 2021 and again 49% (69/140) of the samples were not conform. Further analysis of the contaminants present in some these non-compliant samples demonstrated the presence of opportunistic pathogens such as Burkholderia cepacia complex and Ralstonia Picketii, belonging to the top 2 of the list of organisms responsible for a recall of raw materials in the USA, this last decade. The presence of Burkholderia cepacia complex is of outmost important since infections with members of this complex has been shown very difficult to treat due to a resistance to a wide range of anti-biotics. Taken together this themed quality control action of purified water has demonstrated the importance of strict sanitary standards throughout the entire production chain.