Virtually all users of pharmaceutical water systems pursue lower maintenance and operational costs, increased reliability, and improved life cycle management. Biopharmaceutical companies are looking for innovative methods and newer technology to increase throughput, quality, and uptime.
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Ozone technology delivers the most powerful commercially available oxidant and disinfectant with few detrimental or detracting issues. Ozone sanitization and disinfection has been used for decades, and its adoption in pharmaceutical water systems has been increasing for several years, although it has not yet been adopted broadly in the industry.
When used in lieu of hot water or chemical sanitization for ambient-temperature purified-water systems, ozone prevents the accumulation of microbials and organics and requires less maintenance over the life cycle of the water system. In addition, at 24/7 administration ozone is:
This paper emphasizes the need to understand this technology, its efficacy, and adoption into pharmaceutical water systems to address problems and limitations of legacy processes. This article also explores the efficacy of applying ozone technology in a “packaged” system using best practices. This approach eliminates variables common in on-site integrated ozone systems, and allows easier implementation at lower cost, with better and more predictable results.
Ozone (O₃) is triatomic oxygen, which oxidizes carbon compounds in water to carbon dioxide (CO2 ) when sufficient ozone and time are provided. (Many complex organics oxidize to smaller complex compounds before oxidation to CO2.) Since microbials, bacteria, pathogens, and endotoxins all contain carbon, ozone is an excellent biocide that destroys these organisms by oxidation.
There are three ways to produce ozone:
Electrolysis produces small amounts of ozone in situ from the water system. This method cannot adjust readily to dynamic conditions when loading requirements can change quickly.
UV production is a viable ozone-generating method but has limitations of cost, efficiency, and concentration; it is also energy inefficient when compared to other methods.
Corona discharge is the most efficient commercialized method for ozone production. It uses a reaction chamber with a dielectric barrier in which high voltage is applied to an oxygen feed gas to generate ozone. Modern corona discharge units are adjustable to throttle ozone production up or down under dynamic conditions when load and demands change. Most advanced corona discharge ozone generators use enriched oxygen from oxygen concentrators (usually +90% by weight) as the feed gas due to more efficient ozone production and lower overall operating costs.
Ozone has a short half-life (the time required for the ozone concentration to dissipate to 50%). In 25˚C water, 50% of the ozone decays in approximately 15 minutes (Table A). Different temperatures and water chemistries influence this rate. Ozone reverts to oxygen more rapidly at higher temperatures, for example. Ozone’s short half-life allows disinfection regimes to be calculated easily, according to the concentration required to achieve the desired effect: maintaining pristine systems devoid of microbials and organics. The box below, Compensating for ozone half-life, shows a simplified example of these calculations and how to assess the ozone needed for a given concentration.
Table A: DO3 half-life as a function of water temperature (pH 7) °C Minutes 15 30 20 20 25 15 30 12 35 8\( O_3 n/HL∝ = O_3 c \)
Where:
O3 n: Not compensated for half-life of ozone destruction, amount of ozone required to achieve and maintain desired ozone concentration,
HL: Half-life of ozone according to the water temperature from the table above
O3 c: Compensated or actual amount of ozone required to be injected in order to maintain residual concentration at the actual water temperature.
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Using the relationship and above data, in this case at 25˚C, 10 g / 0.25 hour = 40 g or four times more than without compensation for ozone destruction in water because of half-life.
Source: “How to Compensate for Half-Life of Ozone.” © Absolute Ozone. www.absoluteozone.com. Reprinted with permission.
The aqueous ozone process consists of four steps:
As noted above, modern corona discharge ozone generators produce gas on-site, with control capability for increasing or decreasing output. They may include an air dryer or oxygen concentrator for feed gas preparation, as well as filtration, gas flow control, and gas concentration control.
In the mass transfer process, ozone is dissolved in water. Ozone is more soluble in water than oxygen, although its solubility is dependent on the temperature, pressure, and other factors.
When designing an efficient mass-transfer process, bubble size is a critical parameter. Mitani et.al. stated “[T]he smaller the bubble size, the greater the mass transfer rate of gas. The larger surface area to volume ratio of very small bubbles provides an overall larger area for ozone mass transfer to occur.” The interaction of the bubbles with the water promote higher mass transfer efficiency (MTE), resulting in higher oxidation and disinfection efficiency due to the greater ozone diffusion in the water. For best efficiency, bubbles should be 1 micrometer (μm) or smaller.
Larger bubbles reduce mass transfer and cause greater off-gassing of undissolved ozone, which translates into a loss of MTE. Bubbles coalesce, increase in size, and migrate to the upper surfaces of the water, accumulating in the head space of the tank or pipe. This off-gas must be collected, controlled, and decomposed to oxygen before it can be discharged.
A well-designed mass transfer system will create and manage the surface area for a reliable MTE ratio that is typically greater than 90%, which means that 90% of the ozone gas produced is transferred into solution. The gas-to-liquid ratio is paramount when calculating anticipated MTE of an ozone mass transfer system. An improperly sized and/or designed system can waste or fail to dissolve much of the ozone produced, causing inefficient and expensive operations.
Sizing (mg/l): Amount of ozone delivered to a process
Mass transfer efficiency (MTE): percentage of ozone applied minus the immediate loss of consumption
Ozone demand (mg/l): Amount of ozone consumed by oxidizable material; must be determined empirically
Demand factors: Temperature, pH, organic content, etc.
This is the amount of ozone the generator produces, based on the dosage needed to establish proper oxidation and disinfection.
Calculations for sizing an ozone generator and mass transfer system are based on temperature of the water, contact time (see below), ozone concentration and half-life, volume of water to be treated, and flow rates. Considerations must include MTE, which is the ratio of ozone dissolved, total ozone demand (including the decay rate), and concentration of oxidizable material in the water that will consume dissolved ozone.
Correct sizing is critical as MTE, decay rate, and ozone demand can change rapidly with organic loading and process changes including water temperature and pH variations. Pharmaceutical water quality and conditions tend to be less dynamic, but are susceptible to seasonal changes, enhancing the need for good sizing practices. These start with a proper mass calculation, acceptable process and safety margins, and sizing to account for dynamic operational ranges.
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