CASE STUDY
Ozonia* Ozone Technology
Limit ultrapure water system costs and downtime in the pharmaceutical industry.
Challenge
Ultrapure water is a critical input component of pharmaceutical products. The technology used for disinfection, cleaning, and sanitation affects ultra-pure water system design and impacts facility productivity, production costs, and downtime.
A global pharmaceutical manufacturer in Europe needed to meet ultrapure water loop disinfection goals while maximizing the time between sanitization cycles to limit costs.
Technology Evaluation
The manufacturer evaluated several disinfection and sanitization technologies to achieve their goals, including ozone oxidation, chemical disinfection, and thermal shock sanitization.
Electrolytic ozone technology has advantages over alternative disinfection technologies.
Figure 1: Typical installation
Results
When comparing thermal and ozone sanitization technology, using ozone can reduce the number of sanitization cycles for the main water loop from 52 to two (2) per year, a 96 percent reduction.
The sanitisation time required for the ozone system is eight hours per year. A 96 percent reduction compared to the 208 hours required for thermal technology sanitisation.
The production costs associated with the 200 hours of shutdown time is approximately €100 000 per hour, saving €20 000 000 per year.
The Payback Period for the ozone technology capital investment is 90 days or three months, considering the annual cost-savings.
Ozone systems have a remarkably long service life, upwards of 20 years in most cases. Considering the lifespan for the Ozonia Membrel MKIV, adding ozone technology to any new or existing ultrapure water loop results in a significant project Net Present Value (NPV).
Table 2: Key Performance Indicators
KPIs
Sanitisation cycles
Sanitisation hours
Payback period
Production savings per year
RESULTS
-96%
-200
3 months
€ 20,000,000
Water is the Input for Ozone Generation
Ozonia Membrel electrolytic ozone technology uses water as the input to generate ozone. A proprietary Veolia electrode separates oxygen from hydrogen in water and recombines oxygen to form ozone.
The ozone & water mix is then returned to the water loop. Water quality is not affected while it is disinfected. There is no potential for water contamination because chemicals or other compounds are not introduced.
1
Continuous Disinfection
Continuous ozone oxidation disinfects and prevents contamination and the creation of biofilms. Continuous oxidation provides more stable water quality over time, facilitating faster and less frequent sanitization cycles.
Online disinfection also allows quality control departments to remotely monitor the ozone in the water loop at all times. As a result, ozone technology allows longer periods between sanitization cycles since contamination and biofilms never build to levels that impact performance.
2
Easy Water Loop Sanitisation
The sanitisation process is greatly simplified using electrolytic ozone technology. To begin sanitisation, the ozone destruction process is stopped. Without ozone destroyed, ozone moves freely through the entire water loop.
Simultaneously, the ozone dose is increased to 150 ppm for one (1) hour. The initial sanitisation phase allows ozone to shock oxidize the entire water loop, including the point-of-use injectors and storage tank.
After one hour, the ozone dose is reduced to 60 ppm and kept steady for three (3) additional hours. The second sanitisation phase ensures that proper sanitisation has occurred and for monitoring instruments to validate microbial kills. The entire sanitisation sequence is four (4) hours, after which normal production can begin by resuming ozone destruction prior to points-of-use.
3
Table 1: Disinfection Technology Comparison
TECHNOLOGY
Ozone
Thermal
DISADVANTAGE
-
Initial capital investment
-
Interuption of operations
-
Vapour must be sterile
-
High energy / maintenance cost
-
Fluctuating water quality
-
Possible 'cold spots'
Chemical
-
Interuption of operations
-
Residual chemicals in loop
-
High chemicals / maintenance cost
- Fluctuating water quality
Filtration
-
Bacterial growth is unaffected
-
Regular replacement required
-
Danger of rupture
-
High capital and operating costs
UV
-
Restricted to localised effect
-
Requires shock disinfection
-
Risk of reduced disinfection
Solution
To lower operational costs and limit production downtime, the company chose to install two Ozonia Membrel electrolytic ozone generators, one for each of the two ultrapure water loops in the manufacturing facility.
The maximum ozone capacity on the main water loop is 6g/h. The main water loop is disinfected continuously, 24 hours per day. The main loop requires only two sanitization cycles per year during normal production operations. A weekly cycle would be required for thermal sanitization technology.
The secondary water loop is equipped with 9g/h ozone capacity. Due to the design of the second loop, sanitization is required every 15 days.
Figure 2: Ozonia Membrel Electrolytic Generator