Engineered Water Systems for Pharmaceutical & Life Sciences Manufacturing

Water is one of the most important utilities within pharmredient, a cleaning medium, a rinse water, a process utility or the starting point for higher purity water production.

The treatment system therefore has to do considerably more than simply produce a low conductivity reading.

It needs to produce water consistently, distribute it correctly, control microbiological risk, provide appropriate instrumentation and generate the documentation required to demonstrate how the system was designed and how it operates.

Hydra-Clear designs and manufactures pharmaceutical and high purity water systems around the User Requirement Specification and the process they serve.

Start With the Required Water Quality

There is no single specification called "pharmaceutical water".

The appropriate treatment process depends on the intended use.

Requirements may include:

• Purified process water
• Purified Water
• Water feeding further purification
• Ingredient water
• Equipment rinse water
• Laboratory water
• High purity utility water
• Water feeding clean steam generation
• Specialist process water

The first engineering question is therefore not:

Which RO system do you want?

It is:

What does the water need to do?

Pharmaceutical Reverse Osmosis

Reverse osmosis frequently forms the central purification stage within pharmaceutical water treatment.

A pharmaceutical RO system may incorporate:

• 316L stainless steel process pipework
• Hygienic instrumentation
• Hygienic valves
• Appropriate elastomers
• Automatic flushing
• Permeate diversion
• Conductivity monitoring
• Pressure and flow monitoring
• Chemical dosing
• UV treatment
• Two pass RO
• Appropriate sanitisation provisions

The membrane system is designed from the incoming water analysis and required final quality.

Recovery, flux, membrane selection and pretreatment are calculated rather than assumed.

Two Pass RO & Final Polishing

Where lower conductivity or additional contaminant reduction is required, a second RO pass can be incorporated.

Further polishing technologies can include:

• Electrodeionisation
• Mixed bed ion exchange
• UV treatment
• Final filtration
• Submicron filtration

These technologies are selected according to the required water specification rather than added simply to make the treatment train appear more sophisticated.

Storage & Distribution

Producing high quality water is only half the system.

Once produced, it needs to be stored and distributed without allowing the distribution system to compromise the water quality.

Hydra-Clear designs storage and distribution systems considering:

• Tank turnover
• Recirculation
• Distribution velocity
• Pump selection
• Redundancy
• Materials of construction
• Dead leg minimisation
• Temperature
• UV treatment
• Point of use requirements
• Sanitisation
• Instrumentation
• Sample locations

For high purity applications, the distribution loop forms part of the treatment process.

It cannot be treated as ordinary site pipework.

Microbiological Control

Low conductivity does not automatically mean microbiologically suitable water.

System architecture must consider how microbial growth will be controlled throughout operation.

Depending on the application, this can include:

• Continuous recirculation
• UV treatment
• Appropriate operating temperature
• Hygienic tank design
• Vent filtration
• Drainability
• Sanitisation
• Appropriate surface finishes and materials
• Point of use filtration
• Monitoring and sampling

The correct approach depends on the water specification and manufacturing process.

Automation & Control

Pharmaceutical water systems can incorporate Siemens PLC and HMI control with monitoring of parameters including:

• Conductivity
• Flow
• Pressure
• Differential pressure
• Temperature
• Tank level
• UV intensity
• pH
• ORP
• Pump status
• Chemical dosing

Automatic control sequences can include:

• RO production
• Permeate diversion
• Tank management
• Recirculation
• Duty/standby changeover
• Sanitisation
• Alarm management
• Controlled shutdown
• Automatic flushing

Where required, interfaces can also be provided to customer BMS, SCADA or supervisory systems.

Documentation & Validation Support

For pharmaceutical projects, the documentation is part of the equipment.

Depending on the project requirements, Hydra-Clear can provide:

• User Requirement Specification support
• Functional Design Specification
• Process Flow Diagrams
• Piping & Instrumentation Diagrams
• General Arrangement drawings
• Equipment datasheets
• Instrument schedules
• Valve schedules
• Control philosophy
• Material information
• Calibration documentation
• Inspection records
• Pressure testing records
• FAT documentation
• SAT documentation
• Operating and maintenance manuals
• Commissioning records
• Validation support documentation

The exact documentation package is agreed at the beginning of the project.

FAT & SAT

Systems can undergo Factory Acceptance Testing before leaving our manufacturing facility.

Testing can include:

• Mechanical inspection
• Instrument verification
• PLC and HMI testing
• Alarm testing
• Sequence testing
• Interlock verification
• Flow and pressure testing
• Customer witnessed testing

Following installation, Site Acceptance Testing can verify the system within its final operating environment.

Designed for Reliability

Loss of purified water can stop production.

Pharmaceutical systems can therefore incorporate:

• Duty/standby pumps
• Duplex RO
• Duty/assist operation
• Buffer storage
• Automatic changeover
• Redundant critical instrumentation
• Modular expansion
• Critical spare strategies

The redundancy philosophy is designed around the consequence of equipment failure.