Utility Design Considerations for Efficient Pharmaceutical Manufacturing

When pharmaceutical specialists speak about way of manufacturing effectiveness, they usually emphasize machinery, machinery automation or improvement of production methods. But in practice, many reasons of delays in production, quality non-compliance and sudden stoppage are connected with utility systems that is not taken seriously enough.

Utility systems, including water, steam, compressed air, heating/cooling systems, electrical energy and process gases provide the foundation of any pharmaceutical production company. If utility systems have poor design, no matter how modern the machines are, production of quality goods will not always be possible.

During the evaluation of facility designs, I often see that utility systems are inappropriately regarded as auxiliary technological solutions rather than manufacturing systems. Such treatment creates the problems with maintaining selected levels of consumption and compliance with GMP.

Thus, designing utility systems with efficiency in mind will help to lower not only number of interruptions in production but will also contribute to the reduction of energy consumption and maintenance needs of the equipment.

Utilities are Part of the Manufacturing Process

Utilities are vital components of manufacturing activities. They have a major impact on product quality, environmental factor, efficiency of the equipment etc. Utilities in manufacturing may consist of:

• Purified Water (PW)
• Water for Injection (WFI)
• Pure Steam
• Compressed Clean Air
• Process Nitrogen
• HVAC Facilities
• Chilled Water
• Cooling Water
• Electricity Distribution
• Vacuum Facilities
• Clean Gases

All the utilities have their own specific requirements for design. However, the requirements are based on the same principles such as quality, effectiveness, efficiency, compliance etc.

Begin with a Thorough Utility Demand Analysis

One of the common errors in the design stage is to size the utility systems solely based on the capacity of the installed equipment. In reality, not all the equipment will be operating at the same time and future expansion should be taken into consideration.

Prior to the selection of pumps, boilers, compressors or chillers, engineers should assess:

• Present manufacturing capacity
• Future expansion of production
• Peak hours of usage
• Pick up of equipment
• Variations of utilities by seasons
• Maintenance needs
• Stipulations of emergency operation

Proper calculations of needs allow avoiding undersizing and oversizing of systems.

Design for Reliability, Not Just Capacity

Utility systems that provide adequate capacity under ideal conditions and fall short during equipment failure or repairs are unable to assure the steady supply of pharmaceuticals.

Reliability should be incorporated into the design of utility systems through redundancy and proper choice of equipment. Typical design methods include:

• Pumps working in alternating duty
• Redundant compressors
• Back-up boilers
• Double electricity feed
• Chilled water pump on standby
• Emergency power unit

In respect of vital GMP installations, the goal should be continuous operation rather than maximum utilization of equipment.

Keep Distribution Systems Simple

As facilities grow, utility networks tend to be more complicated. More branches and temporary branches increase complexity and lead to pressure loss, additional maintenance and risk of contamination. Simple designs bring a lot of benefits:

• Easy qualification
• Better fluid dynamics
• Lower pressure drop
• Lower maintenance costs
• Quick troubleshooting
• Better cleaning process

In my experience, a simple distribution system is usually the most resilient one.

Optimize Design of Pipes

Pipe dimensions are frequently undervalued in design of utilities. Too large size of pipes raise expenses of installation and reduce the speed of flow, while pipes of too small size lead to increase in pressure drops and consumption of the energy. Design of pipes:

• Attaining desired speed of the fluid.
• Pressure drop calculation.
• Dryness of the pipes.
• Thermal expansion.
• Preventing dead ends in the pipes.
• Making the maintenance easy in future.

In reference to pharmaceutical water installation, hygienic requirements such as orbital welding and electropolishing the pipes and having the right slope are crucial for the microbiological quality of the fluids.

Select Energy-Efficient Equipment

Utility systems comprise a vast portion of operating costs of businesses engaged within pharmaceutical enterprises. Therefore, it is necessary to decide on equipment depending upon capital and lifecycle costs. Here are a few examples of utility machinery:

• High-efficiency motors
• Variable Frequency Drives (VFDs)
• Energy-efficient boilers
• Premium-efficiency compressors
• Modern chillers equipped with optimized controls
• LED lighting solutions

Though energy-efficient machinery may be rather pricey in the beginning, savings on electricity and service can help make these investments worthwhile over time.

Design for Easy Maintenance

Any utility system requires routine inspection and maintenance from time to time. When equipment sometimes cannot be accessed, it can lead to delay in maintenance, extended shut down time and higher operational risks. Some aspects of maintenance-friendly design include the following:

• Required service space
• Accessibly situated isolation valves
• Easily removable pipe sections
• Intelligently placed utility signs
• Ensured safety of access platforms
• Instrument bypasses
• Good illumination in utility areas

Maintenance-ready systems are usually more reliable than the systems that are difficult to service.

Automation Improves Both Efficiency and Compliance

Nowadays Building Management Systems (BMS) and SCADA systems have changed the game for utilities management.

Gone are the times of manual reading and outdated methods of tracking utility performance thanks to automation. Some of the most relevant parameters to track are:

• Pressure
• Flow rate
• Temperature
• Conductivity
• Differential pressure
• Humidity
• Tank levels
• Equipment status
• Alarming conditions

With automation it is possible for plant personnel to see issues before they develop into problems in the manufacturing area. Also, there are electronic records to support GMP documentation.

Design with Sustainability in Mind

Today energy efficiency is not only an important matter for business but also a kind of a responsibility for producers. There are many ways to optimize utilities consumption like for example:

• Heat recovery from boilers
• Condensate recovery systems
• Variable pumping
• Collecting rainwater
• Water recycling
• Managing compress air leaks
• Optimizing HVAC energy
• Using solar energy

By using fewer utilities, the company will reduce its operational expenses and achieve sustainability goals.

Plan for Future Expansion

Production sites seldom stay the same after being built. New products, additional machinery or production increases may all necessitate new utilities installations. It is important to include in original designs such things as:

• Available electrical capacity
• Additional utility manifolds
• Space for machinery
• Control systems designed with expansion
• Piping flexibility
• Capacity margins

The cost of planning expansion during the design stage is lower than that of modifying an already operating GMP site.

Utility Qualification Should Influence Design

Qualification is simplified by taking validation means into account during engineering. Engineers must make provisions for utilities enabling testing and monitoring by using the following:

• Sampling points
• Calibration points
• Instrument connections
• Drains
• Validation ports
• Pressure test locations

Installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) can all be simplified and take less time because of these features.

Common Design Mistakes

Despite the progress achieved in pharmaceutical engineering, some utility design issues still arise during audits and improving plants. The frequently observed ones are:

• Utility equipment of too large size
• Not enough redundancy for important systems
• Difficult maintenance
• Dead legs in water supply
• Lack of measuring instruments
• Too many losses of pressure because of ineffective piping
• Utility capacity calculation ignoring possible future increase
• Documentation of changes that is not complete

These mistakes can only be noticed when the plant starts its production activities, which complicates their elimination.

Integrating Risk Management into Utility Design

Quality Risk Management (QRM) must be implemented during the process of designing the utility instead of being done after the installation stage. Through effective risk assessment, utility failures which can affect the following aspects can be discovered:

• Quality of the product
• Safety of the patient
• Compliance with the regulations
• Running the business
• Quality of the environment

When it comes to those utilities that are of high risk, more attention should be paid to the process of designing and monitoring them, as well as to implementing adequate redundancy.

For optimal pharmaceutical production, well-crafted utility systems are as essential as production machinery and equipment. The utilities ensure that a facility runs effectively; see that product quality is optimal; and guarantee operational reliability, maintenance efficiency and regulatory compliance. Often, poor design decisions made at an engineering level remain unnoticed until the production process starts, making it work inefficiently, requiring excessive maintenance actions or calling into question the facility's qualifications.

As per my experience, the best pharmaceutical plants are the ones that approach the design of utilities as an investment that will pay off rather than a construction project. By using precise demand analysis, hygienic engineering, energy-saving equipment, intelligent automation design and risk-based design principles, a manufacturer gets the chance to build a utility system that would efficiently work for the whole lifecycle of the facility and at the same time maintain compliance with worldwide GMP requirements.

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