Disinfection of a pharmaceutical water treatment system is an important step to consider when developing or acquiring your new system. There are several types of disinfection and whether it is chemical, physical or physico-chemical, the type of disinfection chosen will have an impact on the cost of capital and operation of your system as well as on its performance.
Although this information is valid for other sectors that require the production of ultra-pure water, this article discusses disinfection from a pharmaceutical perspective. In short, regardless of the sector of activity, the choice of disinfection system should not be overlooked. In this article, we will look at the advantages and disadvantages of chemical, thermal and ozone disinfection systems. Before we start, here are some of the reasons why it is important to opt for a good disinfection system in the pharmaceutical sector.
Why it is important to effectively disinfect a pharmaceutical water treatment system
First and most importantly, disinfection of a water purification system is the deactivation or destruction of microorganisms that may be found on the surfaces of your system, in the water present, or wherever the water comes in contact. The standards for disinfection in the pharmaceutical industry are all pre-established by the organizations that manage the industry. In fact, all pharmaceutical water purification systems must pass compliance tests in accordance with the various organizations. These tests, better known as SOP, are standards operating procedures that must be met in order to be qualified to supply pharmaceutical water.
These SOPs ensure consistent water quality to avoid problems in the production of water for parenteral injection or any other type of water for pharmaceutical use. Therefore, in order to ensure the consistency of operation and functioning of your system, as well as the achievement of the standards operating procedures, it is essential to choose the right type of disinfection for your system.
In other words, the choice of your disinfection technique must be based on the contaminants present, the type of water treatment used and your operational constraints. When the right technology is chosen, you will avoid problems related to government standards, the formation of biofilm that can cause problems for your system and bacterial recontamination of treated water.
Chemical disinfection
In the pharmaceutical industry, this is the most common type of disinfection. Chemical disinfection is most often done with peroxide or chlorine. Although they are the most used, peroxide and chlorine are not the only disinfectants used in the pharmaceutical industry. The choice of disinfectant should be based on the contaminants that may be present in the water and many other factors. For more details, the United States Pharmacopeia addresses the subject in the following article: USP- [1072].
En revanche, peu importe le produit choisi, le procédé de désinfection reste sensiblement le même. Pour effectuer efficacement le procédé de désinfection du système, il faut ajouter le produit choisi à l’intérieur du système afin qu’il soit en contact avec toutes les parties internes du système. Après l’exposition de la solution désinfectante durant un laps de temps préétabli à toute les parties internes du système, le système doit être rincés afin de retirer toute trace du produit chimique.
As mentioned above, this technique is the most widespread in the pharmaceutical sector since it is relatively simple, inexpensive to acquire and very efficient. On the other hand, the operational costs are relatively high for the following reasons:
- Constant purchase of chemicals
- System must be shut down during disinfection
- A lot of handling is required and therefore labor is required
- Water used for disinfection must be rejected
En plus d’un OPEX élevé, la désinfection chimique est souvent difficile à rincer adéquatement, ce qui peut créer des problèmes en aval. De plus, l’automatisation du processus de désinfection chimique est très difficile puisque c’est compliqué de mesurer quand le processus est terminé. Enfin, comme préciser plus haut, cette technique de désinfection utilise une grande quantité d’eau qui doit être rejetée ensuite. L’eau étant une ressource importante, beaucoup d’entreprises s’en soucient de plus en plus et tentent de minimiser leur utilisation.
Thermal disinfection
Il vous est probablement déjà arrivé de recevoir un avis d’ébullition de la ville où vous demeurez, sinon, vous êtes chanceux! Dans le même principe que ce genre d’avis, la désinfection thermique s’effectue en augmentant de façon relativement importante la température de l’eau. Évidemment, dans le cas d’un avis d’ébullition local, c’est pour consommer l’eau. Dans celui d’une utilisation pharmaceutique, la désinfection thermique a comme but de désinfecter l’entièreté d’un système afin d’assurer la production d’eau pure et sans contamination.
The initial costs (CAPEX) for a heat disinfection system are high since this type of equipment requires substantial additions. These include insulation on all parts of the system and all other safety measures such as LOTO (lockout). These additions are essential to ensure the safety of the system operators. On the other hand, the energy costs (OPEX) are very low since all that is required is to heat the water to the right temperature when disinfection is to be performed and that's it. Although energy costs are low, the disinfection process is quite slow, especially if the heating system is electric.
Ozone disinfection
L’ozonation est une des techniques de désinfection des plus efficace. L’ozone est un gaz oxydant extrêmement puissant qui est très volatile, c’est pourquoi il doit être généré sur place avec l’aide d’un générateur d’ozone comme ceux de la série Ozonia de SUEZ.
Sans doute le type de désinfection la plus dispendieuse à l’achat (CAPEX), l’ozonation coûte cher puisque le prix des générateurs d’ozone est très élevé. L’ozonation offre toutefois un OPEX très bas. En plus du prix des ozonateurs, plusieurs autres facteurs font que les coûts initiaux pour un système d’ozone sont élevés, on peut penser entre autres à l’ajout d’une étape de désinfection UV afin de détruire les excédents d’ozone pouvant se retrouver dans l’eau.
As a disinfectant for a pharmaceutical system, ozone has many advantages. Among them, its low risk of causing injuries or accidents is not negligible. The reduction of these risks is caused, among other things, by the absence of chemical handling.
In addition, the ozonation process is very fast compared to other types of disinfection and does not require any workforce since the systems are automated. Because ozone can be irradiated by a downstream UV system, ozonation does not reduce or stop production and does not waste water.
Finally, ozone is very effective against total organic carbons (TOC) in water. As an aside, the TOC concentration in water is directly related to the organic matter concentration. This means that a decrease in TOCs ensures that the risk of pathogen levels is minimized. However, to ensure an efficient and optimal treatment, it is important to validate the necessary ozone concentrations since it can be complex to identify the needs and an overdose of ozone can cause premature wear on your equipment. Moreover, one of the problems of ozone disinfection is caused by its strong oxidizing power. It is quite common to have difficulty calibrating the various sensors in the system since they corrode at an accelerated rate.
Disinfection at the heart of your system
In order to reach the standards operating procedures, the choice of a disinfection technology must be made taking into account all the factors that can affect it. The optimization of your water purification system is intimately linked to the efficiency of all its stages, including the disinfection stage.
Although there are many other types of disinfection technologies, the three we have presented are among the most common in the pharmaceutical industry. In summary, the important thing to remember is that there are experts in the field who can help you identify which technology is best for your situation.
By then, we hope to have answered your questions about these three types of pharmaceutical disinfection. In the event that you are missing information or have additional questions, please do not hesitate to write to us or leave a comment and we will be happy to respond.