(192b) Microbiology of Usp Water Systems

Water is essential in industrial and pharmaceutical operations, where it is used in the preparation and processing of medicines and other health products. In the majority of cases, water is an input, which is incorporated into the product during processing. In other cases, it is removed during processing and it is not present in the product (i.e., tablets and capsules). Water is also used for cleaning and hygiene purposes.

EPA potable water is suitable for human consumption; however, it must not be utilized in the preparation of medicines and cosmetics; cleaning of medical devices; or in health centers for the cleaning and washing of semi-critical areas or devices prior to the application of disinfection or sterilization procedures.

For the reasons above, pharmaceutical and medical devices manufacturing plants, and health facilities must rely on appropriate water purification systems (WPSs). These systems allow the users to meet their particular requirements. WPSs must address the problems related to storage and internal distribution and must guarantee supply accord to the volume required. The required quality or purity at the use points must be met at all times.

The quality of the water or its purity is defined in terms of their chemical and microbiological attributes. In the pharmaceutical industry, the regulatory agencies have labeled as a raw material the water used as an excipient, or used for reconstitution of products, during final chemical synthesis, or during production of the finished product. In fact, the European Pharmacopoeia (EP) contains standards for grades of water for pharmaceutical use including water for injections (WFI) and purified water (PW).

The EP provides standards for the following grades of water: ? Water for Injections ? Purified Water ? Highly Purified Water (HPW)

The quality or purity of these three grades of water is the same for the chemical attributes. However, they differ in their microbiological attributes. For example, WFI complies with the requirements of PW with additional requirements for bacterial endotoxins and microbial bioburden (MBB). HPW is the same as PW but it has a high microbiological quality.

The steps and equipment utilized for the purification of input water in PWSs defines the microbiological attributes of the output water. Therefore, the microbiological quality before and after each piece of processing equipment must be known and controlled.

In this presentation we discuss the microbiological attributes of representative WPSs before and after each piece of processing equipment (discrete manufacturing steps).

The representative discrete manufacturing steps to be discussed are:

? Feed water ? Primary Filtration (Multimedia Filters) ? Hardness Reduction (Water Softeners) ? Chlorine Removal (Activated Carbon) ? Removal of Particle Materials (5.0 ìm filter) ? Removal of Organic and Inorganic Substances (Reverse Osmosis) ? Removal of Dissolved Minerals and Salts (Continuous Deionization Column) ? Treated Water (Storage Tank) ? Reduction of in-line TOC and microbial bioburden (UV Light: 185 and 254 nm) ? Removal of Particles and Bacteria (0.05 ìm filters) ? Distribution Loop ? Before Still (WFI) ? After Still (WFI) ? Distribution Loop (WFI)

In addition, we will discuss important subjects such as: ? which microorganism are normal microbiota ? which microorganism should not be present (objectionable organisms) and how to control them ? acceptable and unacceptable microbial counts. ? biofilms and their relationship to microbial counts ? effects of sampling techniques ? best qualification / validation practices.