Common utility systems in pharmaceutical industry

Pharmaceutical equipment and processes require various things for their efficient operation and quality production. There are many different types of these requirements; some are directly involved with the pharma process and product, while others are not. Among these requirements is the utility, which is as crucial as pharma equipment. In almost all cases, pharma equipment can't operate successfully and produce the required output.

What are Utilities?

Utilities are variables that have a physical existence, impact, and phenomenon on the equipment?, production process, and product itself. These variables store energy, which is then utilized for later benefit.

Utilities are required for the production process, equipment, and product. In the case of equipment, they help achieve the desired functionality or part of it. Utilities enables pharma processes help to undergo chemical reactions and achieve the desired product stage.

Common example of utilities in the Pharma industry includes compressed air and steam

Since utilities in the Pharmaceutical industry  are directly involved and come in contact with manufacturing processes and products, the utilities must meet regulatory regulations and manufacturing standards, just like for pharmaceutical equipment.

Some common requirements for utilities in pharmaceutical industries are as follows

·        The utilities must be free from contamination, mix-up with the products, and with foreign particles

·        Utility systems in the pharma industry must be monitored at various stages and levels for efficient distribution, usage, quality purpose and regulatory requirements.

·        Utility systems in the Pharma industry must be validated before being used in normal routine operations.

·        Monitoring of utility systems offer the following advantages

·        It helps to achieve efficient distribution and helps detect problems them such as leakage

·        Monitoring helps to control the distribution quantity of utilities according to the process of equipment requirements.

·        It helps to prevent under or over-supply. Because in case of under supply, the equipment will not operate according to the process requirement

Utilities in pharma industry

Let's look at some common utilities used in pharmaceutical industry

Compressed Air

Compressed air is the pressurized air, higher than the atmospheric. The normal air in our environment contains a mixture of gasses such as nitrogen, Oxygen, and hydrogen. Additionally, filtering or treating the compressed air with any process is unnecessary.

The compressed or pressurized air contains energy that can be used for further processes and applications.

Compressed air has found application in vast areas of the pharmaceutical industry that can be categorized into two - manufacturing equipment and processes.

Compressed air is used in manufacturing equipment to power different parts or components. These parts or components are designed to perform various functions in an equipment at a specific pressure. For this purpose, the compressed air must be supplied with the specified pressure at which that particular component or part is designed to operate.

For example, some components are designed to operate at 1.5 bar, some are designed to operate at 6 bar. If the compressed air is supplied below these levels, the specified component will malfunction or not work.

Compressed is also directly used in Pharma processes, where instead of powering the equipment,  it comes in direct content with the product. In this case, the compressed air must be purified and free from contamination or impurities. Otherwise, the process will be contaminated and affect the product.

Compressed Air generation

Like other industries, compressed air is generated through air compressors in pharmaceuticals. It consists of a motor-driven pump that compresses air into the compressor at high pressure. The high-pressure compressed air is stored in the attached tank and is filled in the tank up to a specific pressure, defined by the ability of a tank to bear pressure.

Air compressors are connected to the point of distribution through metallic conduits. These conduits must be able to bear high pressures of compressed air. Otherwise, the lines will rupture, causing the compressed air to leak.

Properties of compressed for pharmaceutical applications

As mentioned above, in some cases, compressed air comes in direct contact with the manufacturing process and product. There can be impurities that must be freed from contamination to protect the product or process from being affected and damaged.

Let's look at some common contamination in compressed air and how to prevent these.

Particles

These are the solid particles commonly found in the environment, and compressed air can also become contaminate them.

To prevent particles from contaminating the compressed air, the surroundings of the compressor intake must be clean and free from these particles. Installing a filter at the air intake can also prevent this particle.

Water

Another significant contamination is the water, produced as a by-product of the process. Because the air is forcibly compressed, and as a result of this forceful process, the humidity present in the air is turned into water and makes its way into the compressor and, from there, into the compressed air supply.

Water in compressed air can cause rust to the metallic conduits, damaging the conduits and leaking the compressed air. Additionally, moisture in compressed air will come in contact with the product or process it serves, contaminating them and increasing the chances of microbial growth.

There are two methods to remove water. One is to lower the compressed air temperature, causing the moisture inside to convert into condensation. Another method is a sir separator, which can effectively separate condensate from the compressed air supply. In most cases, an air separator is installed at the air compressors.

Oil

Oil can also become part of the compressed air supply, contaminating it and the process served. A common source of oil is when the environmental air enters the compressor.

Oil can be prevented by utilizing filters that can effectively block vapors and droplets of oil

Steam

Steam is also among the most widely used utilities in the pharma industry and is an effective thermal energy transfer mechanism. It is mainly used in applications requiring high temperatures for process requirements.

Like other industries, steam is generated by heating water at high temperature until it changes its state and is converted to steam.

The temperature generated by steam is directly proportional to its pressure, i.e., the higher the pressure, the higher the temperature it can achieve.

Types of steam in the pharma industry

Commonly, there are three types of steam in the pharma industry - Plant, chemical-free, and purified steam.

Plant steam

Plant steam is used in applications and processes where direct contact between steam and product is impossible. It is generated from raw, untreated water. This water is also mixed with different chemicals to prevent corrosion in the boiler.

Plant steam is commonly used in heat exchangers for HVAC and WFI generation.

Chemical-free steam

Chemical-free steam is also like plant steam; the difference is that it is generated from chemical-free water (used in a boiler to prevent corrosion).

Pure Steam

Also called the pure steam, it is generated from treated water having the specification of USP drinking water or WFI. It is generated from an equipment called Clean Steam Generator.

Pure steam is used in applications where steam comes directly from the product or process. Some examples include,

·        Injectable or parenteral manufacturing

·        Bio-pharmaceuticals

·        Sterile solutions manufacturing

The pipping for pure steam distribution must be made up of Stainless Steel 316L, and it must prevent cold condensation.   Like other processes and equipment, pure steam must be validated before taking it in routine operations.

Water

Water is the basic raw material and the most widely used utility system. It is used in almost all processes, such as formulation, washing, manufacturing, and laboratory operations.

There are different types of water used in pharma industry, depending upon the process and product type, which are describe below

Purified Water

Purified water is treated for foreign bodies, contamination, and chemical and biological bodies in an equipment called Purified Water Generator.

The purified water generator consists of stage-wise filtration elements that filter out contaminants (suspended solids, scale minerals, chemical, biological elements, and total dissolved substance). At the later stage, water is also treated for organic-inorganic impurities and to reduce conductivity through Reverse Osmosis - RO and electro-deionization plant - EDI. Some plants also consist of ultrafiltration and UV to further narrow down impurities.

Purified water is used in applications such as

·        Manufacturing of non-sterile products

·        Cleaning of non-parenteral processing equipment

·        Tests and assays

Water for Injection - WFI

Water for Injection: WFI is a high-quality water used to manufacture sterile drugs. They are produced in a distillation plant that takes input from purified water.

In the distillation plant, the purified water is heated to become steam, which is then cooled down to convert it into water.

Since impurities in purified water cannot be converted into steam, these remain behind, and the resultant water is free from the impurities. The impurities exit the distillation plant from the rejected water outlet

Various gasses

Gasses are also used as a utility system, and like others, their application and requirement depends on the process and product requirement.  A common gas used in the pharma industry is Nitrogen, which is used to push oxygen out of packaging or certain areas. Its advantage is that, since Nitrogen is inert, it prevents reaction with the product. It is also used to increase the shelf life of a product.

Another common gas is oxygen. It is used as a flammable gas where the flame is required, such as in ampoule filling machines to form ampoule.

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.