Water Purification Systems in the Pharmaceutical Sector

Water Purification Systems in the Pharmaceutical Sector

Maintaining sterility at every stage of pharmaceutical production from A to Z is of great importance. Obtaining pure and sterile water to be used in production is considered one of the critical steps. Therefore, purification systems are essential production step in the pharmaceutical industry, as they enhance the water quality and remove unwanted substances.

Uses of Water in Pharmaceutical Production

Pure water is considered a crucial element in various stages of pharmaceutical production, including:

• Cleaning of production equipment
• Manufacturing of certain pharmaceutical chemicals within the semi-finished scope
• Preparation of water for injection

The water used in pharmaceutical production must meet specific standards to ensure the production of drugs with high quality and safety. It should be protected against microbial growth, have the appropriate ionic and organic purity, and be produced in a sterile manner.

In medical fields, the purity of water used is as crucial as its cleanliness. Hospitals, scientific research centers, private dialysis centers, and laboratories all require high-quality and standardized water.

Quality and Criteria of Water Used in the Pharmaceutical Sector

Achieving high purity and compliance with international standards in the production of drugs plays a significant role in quality control. The purity standards set beforehand can be achieved through purification and distribution lines. Thus, well-designed, and operated purification systems are vital.

The water purification device should possess superior filtration capabilities. In the pharmaceutical industry, the microbiological quality of water is of utmost importance. Ensuring microbiological quality during purification, storage, transportation, and usage is crucial for production.

 

PURE WATER CRITERIA SPECIFIED IN DRUG STANDARDS

Quality Criterion	European Pharmacopeia (EP)	U.S. Pharmacopeia (USP)
pH	5-7	5-7
Conductivity	<5.1-1.3-1.1 µS/cm @ 20 °C (PW-HPW-WFI)	<1.3 µS/cm @ 25 °C (WFI)
Total aerobic microbial count	<100-10-10 CFU/mL (PW-HPW-WFI)	<100-10-10 CFU/mL (PW-HPW-WFI)

The water obtained should have appropriate hardness and pH levels, high purity, and sterilization. It should be free from bacteria, viruses, and microorganisms, preventing their formation. To preserve the quality and health, purification systems must be designed and projected to safeguard health and quality.

After analyzing the water used in a facility, suitable purification systems should be established based on the results. The characteristics of the purification system should be determined according to the analysis results.

Water Purification Systems in the Pharmaceutical Industry

Purification must be achieved with systems that meet the quality and specifications required for production. Various purification methods can be selected in the pharmaceutical sector, including:

• Reverse Osmosis
• UV Disinfection
• Dosing Units
• Deionization (EDI/CEDI)
• Wastewater Treatment, Recovery and Recycling
• Filtration and Softening Systems
• Ultrafiltration

The clean and high-quality water requirements vary for each sector, so purification technologies must be tailored to meet the specific needs of the industry or the respective establishment.
In general, purification systems must eliminate heavy metals, solid particles, bacteria, microorganisms, organic and inorganic matter from the water, regardless of the sector they are used in.
In the medical field, such as laboratories, dialysis centers, pharmaceutical production, and hospitals, purification systems should not only clean the water but also prevent the formation of bacteria and microorganisms.

As "Rivamed" in Ankara-Türkiye, we provide manufacturing, installation, project consultancy, and technical service for medical and industrial water treatment systems. As a water purification company in Ankara, we offer internationally qualified design and operational opportunities. We design and utilize technologies suitable for each project both locally and globally. We offer pharmaceutical manufacturers the most suitable solutions for their operations with purification systems capable of meeting the required flow rate, pressure, and temperature.

Our designs comply with the European and American standards for the pharmaceutical industry, providing purified water, free from physical, microbiological, and chemical impurities.
To optimize the operation of water purification equipment, we evaluate the pre-treatment and basic purification requirements in the treated water distribution system according to the pre-analysis of the project through simulation programs during the design phase an addition of engineering knowledge and expertise. Thus, ensuring the suitability of projects in terms of reality is crucial for increasing efficiency.

In the pharmaceutical industry, the installed purification systems remove ions and bacteria from the water. The water used in the pharmaceutical industry may contain ionic pollutants. These ions may consist of various metal ions known as hardness minerals, such as calcium and magnesium. Additionally, other salts and ionic compounds can be present in the water. Through purification systems, the ionic load of water is reduced using ion-exchange resins, removing the ions from the water. All impurities, both organic and inorganic, are separated. The formation of bacteria is prevented, resulting in clean water. In purification systems, UV disinfection and other methods are utilized to neutralize the majority of bacteria and microorganisms in the water, ensuring microbiologically clean water.

The systems should provide high-quality water that meets the required standards according to the source of water used in production, contributing to safe production. The water purification systems established in the pharmaceutical industry ensure high-quality water with low ionic content, microbiologically safe, and free from organic/inorganic contaminants. This purified water plays a significant role in increasing the reliability and quality of drug production and related processes. Moreover, it is essential for environmental sustainability, as treating wastewater minimizes water consumption and reduces adverse effects on the environment.

Reverse Osmosis

Reverse osmosis is a advanced technological system that enhances water quality, ensures energy efficiency, and provides pure water. It involves passing water through a membrane filter under specific pressure to remove unwanted substances.

Reverse osmosis is one of the leading filtration technologies. In the pharmaceutical industry, water purification systems should have highly advanced filtration capabilities. The purity of water is increased through reverse osmosis, which is used to produce pharmaceuticals. The technology also serves as a tertiary treatment for wastewater, offering the option for recovering and reusing water, contributing to the conservation of natural resources.

Advantages of Rivamed Reverse Osmosis Systems

 

• Our Reverse Osmosis device has a CE certificate and is compliant with Class IIb of the Medical Device Directive (MDD) 93/42/EEC Rule 11 of Annex IX.
• Our Reverse Osmosis purification device has superior filtration capabilities, standardly removing dissolved solids up to 2,000 ppm NaCl, and is specially designed to purify more concentrated waters.
• It allows for less energy consumption.
• Our Reverse Osmosis systems consist of submicron filters with a pore size of 0.22 µm in the distribution line, providing extra security.
• The Reverse Osmosis device is IP44 rated, showing resistance to liquid and solid substances.
• It has a high level of protection against operating without water and can provide audio and visual fault notification.
• It can be used efficiently and trouble-free for many years.

Filtration and Softening Methods

Calcium and magnesium ions cause water hardness. Soft water is essential for producing high-quality pure water. Therefore, the purification technology must be capable of ion exchange. Softening systems facilitate the replacement of calcium and magnesium ions with sodium ions. Therefore, softened water has an increased concentration of sodium. The quality and stability of drugs produced in the pharmaceutical industry are directly related to the water quality. Hard water can affect the solubility and stability of components used in drug production. Water softening supports obtaining homogeneous and stable products, improving drug quality.

Untreated hard water can lead to higher energy consumption in heating and cooling systems as well. Hardness minerals can cause scaling in heat exchangers, boilers, and cooling systems, reducing energy efficiency. Using softened water helps reduce energy consumption, thereby lowering costs.

Rivamed Softening Systems contribute to plumbing cleaning and energy savings by enabling ion exchange.

UV Disinfection Methods

This system is used to eliminate microorganisms that can have adverse effects on human health. In UV-C disinfection, ultraviolet rays with a wavelength of 254 nm damage the DNA of viruses, fungi, bacteria, and microorganisms, rendering them ineffective and resulting in their loss of reproduction.

Advantages of the UV method compared to other disinfection methods:

• It is one of the most effective systems used in the pharmaceutical industry to obtain the high-quality water required for production.
• It operates faster and at lower costs, rendering microorganisms and bacteria ineffective.
• Unlike chemical disinfection methods, which may leave chemical residues in the water, the UV method does not produce any chemical residues during the purification process.
• Chemical drug residues that cannot be treated by conventional methods can be easily broken down with the UV method, thereby increasing the potential for biological wastewater treatment.
• It enables purification without altering the taste, odor, and color of water.
• Maintaining water quality is crucial in water purification technologies, and UV technology is one of the most important systems for preserving water quality.

Rivamed Engineering installs high oxidation and disinfection capacity ultraviolet systems.

UF Ultrafiltration Systems

Ultrafiltration is a purification process that alters the physical properties of water without interfering with its chemical characteristics. It is used to remove turbidity by physically altering the water's properties. It is an advanced pre-treatment technology that provides significant benefits for performing purification at the highest capacity. Ultrafiltration is a process used to remove microbiological and colloidal particles from water. In pharmaceutical production, ultrafiltration systems are preferred to ensure the use of high-purity water with low particle content.

We take pride in designing devices and systems with cost-effective solutions according to the purification quality required in water production and contributing to the country's economy.