In the production of pharmaceuticals, eight different types of water are used: non-potable, potable/drinking water, purified water, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection, and sterile water for irrigation.
To make medicinal items, WFI and purified water are used. Reverse osmosis and/or deionized beds are used in the filtration of purified water. Reverse osmosis or distillation are the only processes used to create water for injections. There is no Food and Drug Administration (FDA) acceptance testing necessary to use potable water unless the water is obtained from a source that does not maintain water quality in compliance with Environmental Protection Agency standards1. Drug dosage forms cannot be made with potable water, and neither can lab test solutions. The majority of factors affect the sources of contaminated water in a pharmaceutical business. Water entering a water system may get contaminated due to flaws in the piping. Topical drug products that use contaminated water are the main source of microbial contamination in the industry. The reverse osmosis and deionized water systems should be closely monitored due to the health risks associated with using contaminated water in the process. Seasonal changes can cause changes in the microbial content of the intake water, necessitating at least weekly monitoring of a water system.
An essential component of GMP is the validation and qualification of water filtration, storage, and distribution systems, which is also a crucial component of the GMP inspection. The marketing authorization application should cover the grade of water used at various points in the production of active ingredients and pharmaceuticals. The type of water utilized should take into account both the stage at which the water is used as well as the nature and planned application of the finished product.
Water contamination sources
At the water’s source or in the distribution system after the water has been treated, germs and pollutants can contaminate drinking water. Numerous things, such as the following, can introduce harmful bacteria and chemicals into water:
- Applied fertilizers, insecticides, or other chemicals on land close to the water
- Operations for concentrated feeding (large industrial animal farms)
- Industrial processes
- Sewer overflows
- Storm water
- Wildlife
- Natural substances found in rocks and soil, such as uranium, radon, and arsenic
- water pipe leaks or other issues with the distribution system
In-plant water treatment systems
Larger plants frequently use sand bed filters, either with or without chlorination equipment. The water may, however, be piped to the pharmaceutical manufacturing facility and these may be centrally positioned. These systems’ functionality should be verified before any further interventions are made.
Determine the capacity, the rate of use, the frequency of flushing, and the frequency of sanitizing the internal surfaces if storage tanks are used.
Final filtering is typically not acceptable as the only method of water purification, even if depth or membrane type filters are frequently utilized in water systems. Filtration might be acceptable, though, for instance when used to lower microbial/particulate loads in potable water used as a component in chemical production where water is not required to be sterile.
If free chlorine concentrations of at least 0.2 mg/liter are reached, chlorination of potable water is an efficient treatment. However, keep in mind that any carbon or charcoal filters in the system will eliminate any inhibitory effect on microbial growth after this point by removing this protective chlorine.
Microbiological test for water
the chemical and microbiological examination of pharmaceutical plant water, The number of dissolved salts (ions) in a sample determines how well it conducts electricity. A high ion count reduces the cleanliness of the water and may be an indication of a processing issue. Testing for total organic compounds (TOC) determines whether carbon levels in the sample are kept below a prescribed limit of 500 parts per billion (ppb), with a high level serving as a reliable indicator of sample contamination. In order to ensure that bacterial loads don’t exceed required USP levels, bioburden testing counts the microorganisms in a water sample.