How to select a Water Treatment Plant for your pharma applications

Water is the basic raw material in the pharmaceutical industry, and its quality, efficacy, and safety affect the product being manufactured. For this reason, every effort is made to keep the Water within acceptable parameters. In addition to the product, Water drives the quality of associated processes, such as cleaning.

Water for pharma applications is mainly classified into Purified Water and Water for injection (WFI0. Purified Water is used in less critical operations and products, such as oral solid dosage. On the other hand, WFI is used for more essential operations and products, such as parenteral products.

One major factor that drives the water quality is the ability of plant to generate the water. The plant should be selected keeping in view the manufacturing product’s requirements, to prevent deviations in the manufacturing process.

What is a Water Treatment Plant – WTP

One of many ways to ensure water quality and safety is to use a Water Treatment Plant. It processes the raw water with suitable filtration components and removes harmful elements from the Water. The filtration components include natural, chemical, physical, and electronic systems that are integrated depending on the product requirements. Each stage or component has its unique application, and its output becomes the next stage's input.

Each stage or component is designed depending on the minimum water quality or attributes. If the minimum water quality is not provided, that stage will become faulty and can even damage it. It can also affect the water treatment plant’s performance and reduce its life.

Purified Water is produced using stage-wise purification methods, including pre-treatment and reverse osmosis. Water for Injection—WFI is generated using distillation methods, where purified Water is converted to steam and then condensed to convert into WFI.

The capacity of WTP is mentioned in volume per unit of time (minutes or hours) and is selected based on the facility’s production requirements. Instruments are included to monitor vital product and process parameters. They keep an eye on the process and product. The output of these instruments is used by the automation system to maintain parameters within limits and alert personnel in case of deviation or emergency.

Modern-day WTP is operated and controlled through automation systems that automate the entire operation. It enables adjusting parameters and record data for various critical product & regulatory requirements.

What can go wrong if the appropriate WTP is not selected?

Let’s discuss some disadvantages of wrongfully selecting pharma WTP

• WTP individual components and treatment stages are designed depending upon various parameters, such as feed water and application. Wrongfully selecting a WTP will damage these components and intermediate treatment stages, due to incompatibility with these factors.

• The product will fail to deliver the required quality attribute and product-specific parameters.

• Failure to achieve required capacity: The WTP will fail to reach the plant’s necessary capacity, resulting in production delays.

Some tips on selecting WTP for your pharma applications

Before purchasing or designing a water treatment plant for your pharma applications, it is necessary to determine what your requirements are. Let’s describe some of those.

What is your feed water?

WTP uses raw Water as a feed, and processes it into filtered Water. The values of different parameters, such as turbidity, chemistry, and feed water flow, determine the level & intensity treatment stages requirement. If appropriate treatment stages are not included in the feed water, it can contaminate the process and affect the end-product.

There are different types of feed water, such as surface water, ground water, municipal Water, or from natural resources. These water sources differ in various factors, such as organic matter, microbial activity, suspended solids, and minerals.

When designing or selecting your WTP, always consider the feed water source, through water analysis, such as TDS, microbial count, hardness, and minerals. The result of water analysis determines the selection of different stages, such as treatment for organic matter, softening, demineralization, or chlorine-based treatment.

What is your application of Water?

The pharmaceutical industry includes various processes, each with varying water quality requirements.

• Cleaning equipment after the completion of one batch or product

• Different utility applications, such as in machines

As mentioned earlier in this article, there are two common types of water employed for the product. Purified Water and Water for Injection

Determining your product requirements is beneficial before selecting a treatment plant. Different water types require different treatment stages that cannot be used for other pharmaceutical applications.

What is your required capacity?

The capacity of WTP is the total volume of Water produced in a given unit of time, i.e., minutes or hours. It defines the ability of all intermediate stages to process and produce Water of the desired quality. If the WTP is operated within its capacity, the processed Water will remain within the quality limits. However, if the WTP is operated above its rated capacity, the Water produced will be lower than the acceptable quality limits.

Many elements in the pharmaceutical facility consume Water. The volume of product or solvent required for product manufacturing depends on the water consumption. Machines also consume Water for their processes, such as to wash containers before sterilization and filling. In this case, the total Water consumption depends on the total consumption by the machines. The same goes for other processes, such as cleaning and daily load.

When selecting WTP, you always determine your daily water requirements. Calculations based on product manufacturing, machine requirements, and other factors help determine the WTP capacity, which can be used to design the treatment plant.

Treatment Technologies

WTP consists of many treatment technologies, for pre-treatment and final treatment. Each section has different technologies that depend on the feed water and product parameters.

Always consider the treatment technologies when selecting a WTP for your applications. Most WTP manufacturers offer the flexibility to include different treatment technologies.

Regulatory Compliance

Every pharma process, area, department, or product is strictly regulated by regulatory compliance, and the same goes for WTP. The regulatory bodies review the requirements during their routine visit. The requirements relate to different processes, including monitoring, records, processes, and areas. The bodies can fine the pharma manufacturer, if the guidelines are not followed.

Always consider regulatory requirements for the region, country, or market in which you are planning product manufacturing. The best practice is to involve the quality department in monitoring regulatory requirements.

Instrumentation

Instrumentation is an integral part of WTP. It monitors different water parameters, which are then used to control the process and water quality. Instrumentation ensures the process runs according to approved procedures and that deviations are identified in a timely manner without any loss.

Instrumentation for all critical and necessary parameters must be included in the design of WTP to benefit more from it.

When selecting a WTP, always consider the types of instrumentation used in the WTP. The instruments for all critical parameters should be included during the selection process. Some critical instruments for WTP include, but are not limited to, the following

• pH meter

• Conductivity meter to check for suspended particles

• Total Organic Content - TOC for measuring the organic content in the Water

• A turbidity meter to measure the cloudiness or dizziness

• Hardness tester

In addition to water quality, process-related instrumentation is also required. These instruments help control the process, maintain continuity, and prevent faults in WTP operations.

Automation components

Automation components have become necessary for every pharmaceutical equipment, including the WTP. They help control and automate the process to achieve optimum water quality.

There are various automation components, and their selection depends on the plant operations, if the operation is

• Semi-automatic - only basic components, such as a PLC. HMI and sensor are sufficient

• Fully-automatic - advanced PLC, HMI, Communication system, actuator drivers, and      instrumentation to provide real-time connectivity and data collection.

The software system should also be 21 CFR part 11 compliant, focusing on electronic signatures and data integrity to protect software-based records.

Water Storage

The water product from the WTP is not directly fed to the production department or the point of use. Instead, it is first stored in storage tanks and then transferred to the point of use. This helps to contain the water supply and prevent delays during spikes in demand.

Before designing your WTP, you must make arrangements for storage tanks. Sometimes, treatment plants manufacture storage, while some don’t.

• Storage tanks must meet the capacity of the plant

• It should meet all necessary quality requirements, such as surface finish and      stainless steel.

• It should include all the required instruments, such as flow and level, to monitor      & control the water supply.

In some systems, the water level is synchronized with the WTP operation. If water levels rise to the highest in the tanks, the WTP is automatically stopped to prevent overflow. Similarly, if the tank level remains within the safe limit, the WTP is continuously operated.

Distribution System

Distribution systems are used to distribute Water from storage tanks. They consist of a pump, motor, associated control system, and piping from the treatment plant to each department where Water is required.

Before purchasing WTP, always determine the possibility of a distribution system. The distribution system should be made available with all of its requirements based on production demand.

Some systems integrate the water level in the storage tanks to control the operation of the distribution system based on water availability.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.