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Water in Latin America: water purification in the pharmaceutical industry

  • Water in Latin America: water purification in the pharmaceutical industry

About the entity

Leading Laboratory in Food Quality Control, Water Quality, Pharmaceutical Products and Cosmetics
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With more than 30% of the renewable water resources in the world, Latin America is the continent with the highest water availability. With almost 3100 m3 of water per person per year, it doubles the global average. Most countries in the continent have either high or very high water availability based on their surface area and population, but this does not mean water is equally accessible to everyone.

In Latin America, the same as elsewhere in the world, there are different industrial water uses, ranging from using it as a raw material, to being an important part of production systems. Industrial water uses in Latin American countries were estimated to consume about 460.000 million litres per day in 2015, and a threefold increase in consumption is expected by 2035.

The socio-economic sectors that use more water are the agro-industry, with 70% of the water use, and the remaining industries, with 20% of the water use. In the pharmaceutical industry, water is a critical raw material to manufacture pharmaceutical products and cosmetics, representing between 60 and 80% of the total water consumed by the industry.

The water used by the pharmaceutical industry is prepared from potable water, suitable for human consumption. Therefore, the first level of decontamination is the one established by the national or regional regulations applicable in each jurisdiction to obtain potable water. We should note that, in order to maximise disinfection, disinfectants (such as chlorine, ozone, chlorine dioxide, chloramines, etc.) are used to treat potable water, and these could lead to the formation of disinfection by-products which are not wanted by the pharmaceutical sector. The most widely used disinfectant is chlorine, very effective to eliminate pathogenic microorganisms; however, it can result in certain toxins that would invalidate a product or process in the pharmaceutical industry.

Water is crucial for the pharmaceutical industry, and the quality of the final product depends to a large extent on water safety.

The very nature of pharmaceutical products supports the quality controls this industry is subject to; one of the main quality controls involves purification of water intended for pharmaceutical use. The specifications that the different grades of water for pharmaceutical use must comply with are established by International Pharmacopoeias, as shown in Table 1 (European Pharmacopoeia-Ph Eur, United States Pharmacopoeia-USP).

Table 1: Specifications for different grades of water intended for pharmaceutical use according to the pharmacopoeias (USP and Ph Eur)

Based on the use of the water by the pharmaceutical industry, different chemical and/or microbiological specifications will be required.

Grades of water for pharmaceutical use:

Purified water: obtained from potable water, through two-stage reverse osmosis in combination with other appropriate techniques (ultrafiltration and deionisation). Purified water is used to prepare products that require high biological water quality, but which do not require water for injection. It is an inactive ingredient used in liquid pharmaceutical forms and also to prepare most solid forms. It is also used as the base to obtain other types of water with higher quality, such as water for injection.

Highly purified water: Obtained through double-pass reverse osmosis (plus deionisation/ultrafiltration), from purified water. It is used as an ingredient in preparations that require high biological water quality, except for those requiring water for injection.

Water for injection: obtained through distillation of potable water or purified water. It can also be produced though distillation or reverse osmosis of purified water. It is used as an inactive ingredient in sterile preparations for parenteral administration, to wash equipment used with sterile preparations, and to prepare certain chemical substances.

In any event, the last cleaning or rinsing of equipment should be done with water of the same quality as the water used in the preparation.

In order to obtain water of the proper quality and comply with the specifications established for each grade, pharmaceutical companies make considerable investments in water purification, storage and distribution equipment, and then obtain quality certification for their systems. For this, they use different combinations of the methods to produce and treat water, which are also established in international pharmacopoeias. This requires water quality to be monitored from the first stages of pretreatment to the last purification stages.

Finally, it should be noted that water stagnation in any purification system can lead to microbiological contamination and the creation of biofilms. This hazard can favour the presence of undesirable bacteria, such as coliforms, or even pathogenic bacteria including Pseudomonas aeruginosa, which can prevent compliance with monitoring and safety protocols for water purification systems. If not monitored and prevented, contamination could affect the final product.

Ultimately, water is crucial for the pharmaceutical industry, and the quality of the final product — the medicinal product — depends to a large extent on water safety.