The quality standards of pure water required for pharmaceutical production are becoming stricter, and more and more mandatory international standards for pharmaceutical production are increasing. Craig Howarth, the managing director of Hanovia Ltd., introduced me to some interesting new developments in UV disinfection and dechlorination.
introduction
Ultraviolet (UV) technology was originally used to ensure the complete disinfection of city tap water. Since the technology was introduced more than 40 years ago, it has now been used in many industries worldwide including pharmaceutical companies for disinfection, TOC (total organic carbon content) degradation, ozone and chloramine decomposition, and residual chlorine removal from production process water. Water is the most used substance in the pharmaceutical process, and disinfection technology has been adopted under the drive of more stringent standards and increasingly complex process requirements.
Pharmaceutical production is generally composed of several process stages, and may itself be contaminated by microorganisms between different stages, and ultraviolet disinfection can be used as an effective guarantee to ensure that the drugs will not deteriorate between various process stages.
The typical stage of UV installation is after the activated carbon filter or before the RO, or the UV disinfection and TOC degradation system is installed in the finishing unit. An appropriate UV disinfection system is added after the activated carbon filter or an appropriate UV disinfection system before the RO treatment unit will kill 99.9% of bacteria in the incoming water.
UV disinfection technology
Ultraviolet disinfection systems are generally divided into two distinct types: low pressure and medium pressure. The low-pressure system produces a monochromatic spectrum (254 nm wavelength), while the medium-pressure system produces a multicolor ultraviolet spectrum (wavelength between 240 and 310 nm).
Ultraviolet light breaks the adenine and thiamine molecules of microbial deoxyribonucleic acid (DNA), preventing it from continuing to reproduce. The microorganisms can thus be killed without using chemicals. Although 254 nanometers is the effective disinfection wavelength, the ultraviolet light with the wavelength of 265 nanometers can be most effectively absorbed by DNA (see Figure 1). Understanding the differences in the sterilization capabilities of these different wavelengths of ultraviolet light is the basis for designing ultraviolet disinfection equipment with good sterilization and high efficiency. In general, low-pressure systems are best used for small flow, intermittent systems, while medium-pressure technology is more suitable for high-velocity water disinfection.
UV system installation
The UV equipment can be installed in various locations in the ultrapure water system (see Figure 2). Installing or retrofitting existing pipelines and vessels is relatively simple, and can achieve the lowest degree of production disturbance and the smallest footprint requirements. Depending on the purpose of use, the only work that requires regular maintenance is to replace the UV lamp tube every 12 months, which can be completed by a simple operation by field staff. Once installed, the treatment plant can be operated 24 hours a day, without downtime for daily sanitary maintenance and disinfection of the system.
Validate
The UV dose can be calculated by 3 independent variables:
UV dose = UV intensity X residence time X The transmittance of water ensures the accuracy of UV dose measurement, and each process parameter needs to be measured. Many UV monitors have adjustable potentiometers that can be recalibrated with a simple operation. This allows the measured value to be either a relative value or an absolute value. The probe of the monitor should be sealed and calibrated according to existing standards. Each lamp and monitor should have the ability to provide inspection data to ensure the measurement of sterilizing UV light output (measured in watts / cm-2), rather than by estimation. The same is true for monitors (measured in mw / cm-2). Usually the surveillance cameras may not be able to be adjusted on site, so these cameras should be returned to the manufacturer, who can recalibrate according to the testing requirements.
Each bulb should have a unique serial number and spectral certificate. This standard practice is to enable measurement rather than inference. The UV dose is expressed in mj / cm-2 and each bulb is equipped with a dedicated surveillance camera. Only those products manufactured with good production technology can record the dose of ultraviolet light received by the water body, and the record of any ultraviolet faults can be included in the monitoring and verification process, and the date and time can be displayed at the same time.
TOC degradation
Recent studies have shown that short-wave UV (below 200 nanometers) is very efficient at decomposing organic molecules in water, especially low molecular weight pollutants. Hanovia's experiments with the PFW (purified water) circuit show that ultraviolet light with a wavelength below 200nm degrades TOC in two ways: one method is through direct photolysis, which destroys the chemical bonds in organic matter by ultraviolet energy The second method is the photolysis of water molecules to generate charged OH- radicals, which attack organic compounds.
Dechlorination
The water supply of many pharmaceutical factories comes from urban water supply. Free chlorine has been widely used to maintain the continuous disinfection capacity of water bodies. This practice has been in existence for more than 50 years. When chlorine is added to the water, it will form trihalomethane (THM) compounds with humic acid, palmitic acid and other organic substances in natural water. Since some THMs have been shown to cause animals to develop cancer at relatively low concentrations, regulatory agencies, such as the US Environmental Protection Agency (USEPA), have set standards for the highest levels of pollutants in drinking water (since 1979 in the US (Environmental Protection Agency regulations, the maximum content is 100 units per billion (ppb)).
In addition, due to the nature of chlorine, it may damage sophisticated process equipment, such as reverse osmosis (RO) membranes and ion exchange (DI) resins, so it must be eliminated once the chlorine disinfection function is achieved.
So far, the two most common methods for dechlorination are granular activated carbon filters or additional neutralizing chemicals such as sodium bisulfite and sodium metabisulfite. These two methods have their own advantages, but there are some serious shortcomings. The GAC filter, because of its porous structure and rich nutritional environment, can easily become a breeding ground for bacteria. Dechlorination chemicals, such as sodium bisulfite, are usually added just before the reverse osmosis membrane, and can also become an incubator for bacteria, causing biological contamination of the membrane. In addition, there are dangers when handling these chemicals, and there are dangers of excessive or insufficient due to human error.
Now, UV is becoming more and more popular as an effective alternative to dechlorination. It does not have the disadvantages of GAC or neutralizing chemicals, and can effectively reduce free chlorine and chlorine compounds (chloramines), and the by-products formed are also easily removed.
Ultraviolet light with a wavelength between 180 nanometers and 400 nanometers will produce a photochemical reaction that decomposes free chlorine to form hydrochloric acid. The peak wavelength range for decomposing free chlorine is 180 to 200 nanometers, while the peak wavelength range for decomposing chlorine compounds (mono-, di-, and trichloramine) is 245 nanometers to 365 nanometers. The UV system alone can successfully decompose chloramines up to 5 ppm and remove free chlorine up to 15 ppm.
The UV dose required for dechlorination depends on the total chlorine content, the ratio of free chlorine to combined chlorine, the content of organic matter and the target concentration. The usual dosage for removing free chlorine is 15 to 30 times higher than the general disinfecting dosage of 30,000 microwatt-seconds per square centimeter (mw-s / cm2). Another important benefit of using UV dechlorination is efficient UV disinfection, TOC degradation and improved overall water quality.
Procter & Gamble recently installed Hanovia's UV dechlorination equipment at its manufacturing facility in North Carolina, USA. Prior to this, sodium bisulfite dechlorination was used. The UV equipment was installed in front of the two layers of reverse osmosis membranes, and the system was put into trial operation shortly after installation. The data showed that the frequency of reverse osmosis membrane cleaning decreased dramatically-from an average of eight times per month to only two times per month- — Annual savings of $ 70,000. Reverse osmosis membrane shutdown maintenance times are also greatly reduced.
"We are very happy to use the Hanovia UV system," commented one of the company's process engineers. "Since the installation of the UV system, we have not only saved costs, but also the production shutdowns caused by the shutdown of the factory due to fouling of reverse osmosis membranes have been greatly reduced. UV provides a high standard of dechlorination and avoids all Disadvantages of granular activated carbon filters. "
in conclusion
The UV system is an important process tool that can ensure that the purified water circuit operates under the highest microbiological contamination standards. The advantage is that it is easy to install in various aspects and has a small footprint; it is easy to maintain and can be performed by on-site staff; as a non-chemical treatment method, it will not affect the stability of the product, and the product will not have unexpected residues , Color and smell.
Due to its independent tracking and monitoring capabilities, the UV dose can now be accurately measured after intensity calibration according to absolute standards, rather than inferred from calculations. In addition, the data records ensure that the results of the operation can be measured and proven, rather than simply guessing. It has also been successfully used in TOC degradation, residual chlorine and chloramine removal by some of the world's top pharmaceutical manufacturers.
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