One of the most indispensable components in manufacturing of all pharmaceutical products is purified water. Validation of the water system is necessary to ensure that the specified quality of water is consistently produced. If you’re a pharmaceutical manufacturer, water system validation is certainly indispensable for the production of your pharmaceutical products.

Indeed, water is a significant component of every pharmaceutical product, this is why it should be validated to safeguard the consistent production of high-quality water. In the pharmaceutical industry, the quality of water used in production of finished products is the most important thing to consider. It is pivotal in intermediate reagent preparation, analytical processes, especially in case of parenteral products where quality of water must be as per Pharmacopoeia.

The quality of the pharmaceutical water system should fulfill all the regulatory requirements. It can’t be denied that any laxity in proper monitoring of the water system can be a cost burden on your manufacturing firm as it will lead to product recall, waste of time and money. Water system validation is essential to get the knowledge of all the physical, chemical, engineering and microbiology issues related to water production and distribution.

Significance of Water System in Pharmaceuticals

• High quality water is vital for the manufacturing of pharmaceutical products.
• Water is the most commonly used raw material in pharmaceutical manufacturing.
• Water is directly or indirectly used in pharmaceutical manufacturing such as a major component in injectable products and in cleaning of manufacturing equipment.
• Water is an important raw material in GMP and in validating the manufacturing process.

Why is water system validation needed?

It is important that the quality of water should be specific for product quality. Low quality of water can lead to product degradation, contamination, loss of product and profit.
• Usually, water contains organic and inorganic impurities, microbial contamination, endotoxin, particulate contamination which can be inappropriate for manufacturing of pharmaceutical products. Moreover, it can have a drastic impact on a product’s quality and efficiency.
• Water is a critical component in manufacturing of pharmaceutical products. Even the distribution process can also lead to contamination. This is why water system validation is an important aspect of manufacturing plants in the pharmaceutical industry.
• It is mandatory for factories to ensure water system validation for regulatory compliance.
• To ensure reliable, consistent production of water for consistent quality.
• To prevent unacceptable microbial, chemical and physical contamination during production, storage and distribution.

Grades of water for pharmaceutical Purpose

• Potable water
• Purified water
• Water for Injection (WFI)
• Sterile water for injection and inhalation.
• Sterile bacteriostatic water for injection

Conditions for water system validation in pharma

• It must maintain compliance with pharmacopoeia requirements.
• A proper sampling system from correct points with appropriate frequency.
• Detecting and resolving common contamination problems.
• To consistently produce water appropriate for industry standards for quality.

A quick look at few factors to maintain and control water system validation in pharma

• A systematic maintenance program should be established to ensure that the water system remains in a state of control.
• Procedures for operating the water system and performing routine maintenance and corrective action should be written, and they should also define the point when action is required.
• A proper monitoring program is a critical quality attribute and operating parameters should be documented and monitored. The program may include a combination of in-line sensors or recorders (e.g., a conductivity meter and recorder), manual documentation of operational parameters (such as carbon filter pressure drop) and laboratory tests.
• A routine sanitisation must be conducted as per the system design and the selected units of operation to maintain the system in a state of microbial control.
• A preventive maintenance program is significant to establish what preventive maintenance is to be performed, the frequency of maintenance work, and how the work should be documented.

Different techniques used for water treatment

• De-chlorination (sodium bisulphate carbon filter)
• Filtration
• Ultra-filtration
• Softening
• Demineralisation
• Reverse osmosis
• UV treatment
• Deionisation
• Ozonisation

Different equipment and components for water system

• Piping
• Valves
• Pumps
• Pressure Gauges
• Heat Exchangers
• Distillation Unit
• Filters
• Deionizers
• Sensors
• Auxiliary equipment

Validation Concept

It is essential to demonstrate that the process or system consistently produces the specified quantity and quality when operated and maintained according to specific written operating and maintenance procedures.

In the process of validation, it is crucial to prove
• Engineering design
• Operating procedures and acceptable ranges for control parameters
• Maintenance procedure to accomplish it
• The system must be carefully designed, installed and tested during processing after construction and under all operating conditions.

Water System Validation Lifecycle

Determination of quality attributes
• To get a clear understanding of the required quality of water and its intended use.
• It should be determined before starting the validation.
• To establish validation protocols, it is important to define required quality attributes.
Validation protocol
• A written plan stating how validation will be conducted and defining acceptance criteria for quality
• The protocol for a manufacturing process identifies
• Process equipment
• Critical process parameters
• Product characteristics
• Sampling
• Test data to be collected
• Number of validations runs
• Acceptable test results
Steps of validation
• Establishing standards for quality attributes.
• Defining system and subsystem.
• Designing equipment, control and monitoring technologies.
• Establishing standards for operating parameters.
• Developing an IQ stage and OQ stage.
• Establishing alert and action level.
• Developing and prospective PQ stage.
• Completing protocols and documenting each step.