Access to clean water is one of the most important factors considered in selection and development of a pharmaceutical manufacturing facility. Without readily available appropriately clean water, processing would be nearly impossible, changeover and cleaning of reusable equipment would cease, and overall production would grind to a stop.
Ozone is used as an alternative to heat sanitization with hot water and steam or chemical disinfection using chlorine, chlorides, peroxides and other chemicals. It is one of the strongest commercially available oxidants, with a disinfecting strength 3,000 times that of chlorine. Ozone effectively kills bacteria, viruses, yeast, fungi and other microbes as a function of time, susceptibility of the target organisms(action), ozone concentration and water temperature.
While there are a number of potential sources of contamination in storage and delivery systems for purified and sterile water, one of the most common problems facing purified water (PW) production and delivery is the prevention and removal of biofilms.
Biofilms occur in a wide variety of systems, but are endemic to water systems in the biopharmaceutical industry.
As a non-specific biocide, ozone reacts rapidly with most hydrocarbons to effectively destroy the biofilms’ EPS, and the microbes and organic residue material within these films.
Ozone is a viable and accepted technological option for water sanitization and one of the most effective technologies against biofilm mitigation. It’s rapidly increasing popularity and acceptance as a solution for PW disinfection is due to its cost-savings potential, including its ability to save significant time during the cleaning cycle. Micro Pollutants and Pharmaceutical Residue
Ozonated water leaves no chemical residues, unlike other chemical sanitization procedures, and in ambient water reverts back to oxygen naturally. Therefore, it does not need to be flushed as does chemically sanitized water.
Ozone is both safe and economical to use since it can be reliably generated on-site as needed, avoiding handling and costs associated with strong oxidant transportation and storage. It is generated at ambient temperature and is soluble in ambient temperature water, increasing ease of operation. The infrastructure requirements for thermochemical sterilization and subsequent decontamination are significant, and the use of ozonated water can greatly reduce capital, operations and maintenance costs of water treatment.