Steam for Pharma Applications

The manufacturing industry, including the pharmaceutical, requires a range of utilities to execute their critical machinery and processes to run their manufacturing businesses. Each utility has dedicated functionality and cannot be replaced with any other system. Among them is Steam, which allows manufacturers to use its latent heat capability for various applications in a more efficient and cost-effective way.

Steam has also proven applications in the pharma manufacturing industry. They are used to execute sensitive processes, run critical operations and many more like these.  

What is Steam?

Steam is a gaseous form of water converted from solid or liquid through evaporation or sublimation. It is achieved by heating water at high temperatures until the phase change occurs.

Upon heating, the bond between water molecules starts to break. At limits, some molecules break apart, which is what we called it a steam.

The steam’s latent heat can be a practical energy source for many industry applications. It can provide more power than utilities for a given amount without additional components or alterations in the machine or process.

Steam in light of the pharma industry

The pharmaceutical industry is a significant producer and consumer of Steam, among many manufacturing industries. Steam's capability is used for many pharma applications other utilities don't have, or it would be costly if other utilities were used for the same application.

Steam is generated in a boiler and distributed to a particular point of requirement through a piping network installed throughout the facility. The piping network must be capable of supplying steam without degrading its quality, pressure and flow.

Instrumentation and measuring devices are also installed in the piping network to monitor its distribution and correct & prevent any problems.

Steam in the pharma industry is much more critical because, in some cases, it comes in direct contact with the container or product itself, requiring that the steam for such applications must be generated with high purity and sterility. In other cases, the machine operation or process is directly dependent on the availability of steam. So for this reason, there must be a constant supply of steam without pressure and performance drop to enable equipment to achieve relevant product properties.

Steam has many attributes that play a vital role in the performance of an attached machine or process, among them steam pressure. Every machine or process is designed to work or operate at a specific steam pressure, and must be supplied at the design pressure. If steam pressure drops below the minimum threshold level, it will affect Steam's ability to provide the required energy source to the desired machine or process. For this purpose, the piping network must be capable enough to supply steam without reducing the steam pressure due to leaks, loss or wastage.

Applications of Steam In Pharma applications

The most common application of steam in pharma is that it generates high temperatures, which enables manufacturers to use this heat for various applications.

Some ways that steam is utilized in pharma applications include but are not limited to

●Machine operation or individual components

●Sterilization

● Humidification

Lets briefly discuss each of the above.

Machine operation or individual components

One of the applications of steam in the pharma industry is operating a machine or individual component(s) in a machine. Commonly, it involves heating a machine or its components, which performs its dedicated function.

For example, some liquid products require heat during manufacturing to achieve their desired therapeutic effects.  The product will not reach its capabilities if heat is not supplied. For this purpose, steam is used to provide the heat by heating the manufacturing vessel to the required temperature.

In some instances, individual components also require steam to generate heat that can be used for various applications, such as heating coils in AHU to warm the air flowing through AHU.

Sterilization

Sterilization is a critical process in the pharma industry to de-contaminate items used in product manufacturing by exposing the items to a specified temperature. There are many methods of achieving high temperatures for sterilization, and among them is using steam to heat.

It is performed by exposing steam to items in a container, in an equipment called Autoclave. The chamber is heated using steam up to specific temperatures, per the product requirements. The process continues for a particular period, depending on the product requirement.

For efficient sterilization, the steam must be supplied with a specific pressure. Otherwise, the steam will fail to achieve the required temperature, ultimately failing sterilization.

Humidification

Another primary application of steam in pharma industry is in humidification solutions, where it helps to provide and maintain the required humidity levels, which is critical for product safety and quality.

The pharmaceutical industry requires strict humidity control in their manufacturing areas or facilities because it alters the chemical or raw material properties, affecting the pharma product's therapeutic effects.

For this purpose, precise humidity is controlled within a limit to prevent affecting the drug properties and undergoing the process. Although the HVAC system is also installed in all critical areas, it cannot provide precise humidity requirements due to long operational hours and high energy consumption.

Humidification solutions are used in all product-critical areas to provide precise humidity levels. They help maintain the humidity levels with a custom solution for individual regions or product requirements.

Humidifiers use steam to maintain the humidity levels by generating and dispersing steam into the air, raising the humidity levels. The amount of steam can be controlled depending on the area or application requirements.

Types of Steam in the pharma industry

Some common types of steam in the pharma industry include the following.

● Utility steam

●Chemical free steam

●Clean Steam or Pure Steam

Utility Steam

Utility steam is produced from raw or portable water in standard industrial boilers. Utility steam contains different chemicals and additives in it, because these chemicals are used in the boiler for different purposes, such as to prevent scale and corrosion in the boiler and attached piping system.

This type of seam cannot be used for critical processes and products due to its impurity levels. Instead, it is used for general industrial-grade operations in the pharma industry.

Chemical Free Steam

Chemical-free Steam is a type that does not contain volatile chemicals. It is generated from pre-treated water, and the chemical meets the criteria set by the FDA Generally Recognized as Safe (GRAS).

They are used in applications where steam does not directly contact the product.

Pure Steam or Clean Steam

Pure or clean Steam is used most in pharma processes and product applications. It meets the highest standard of purity and is considered safe for critical applications in the pharma industry.

When condensed, the clean Steam must meets the USP Water for Injection – WFI characteristics.

The most general application of clean Steam is steam sterilization , such as in autoclaves. Pure Steam generates the required high temperature, typically 100⁰C or 121⁰C, in an autoclave chamber containing items to be sterilized. The items are held at high temperature for a specified time, and after completion of the time, items are off-loaded from the autoclave chamber.

Clean Steam is also used in Steam to modify clean rooms, where Steam can be exposed to the product.

How Steam is generated?

The pharmaceutical industry has two types of equipment for generating Steam – an Industrial Boiler and a Steam generator.

An Industrial Boiler is a boiler used to generate Steam for industrial-grade and non–critical purposes. It heats the water to its evaporating temperature until steam is generated. Different control facilities boiler operation and include temperature control, pressure regulation, and other safety devices.

Steam is supplied to the point of requirement by the piping network, which is dedicatedly installed to handle the steam supply.

Since steam generated from industrial boilers does not comes in direct contact with the product, nor it is used in critical processes, it is generated from raw or untreated water. Similarly, the piping network for Steam does not require specialized requirements.

Steam Generator

Steam generators generates clean Steam that can be directly used in applications in which it comes in direct contact with the product. it's operation mode is same like ordinary boilers, i.e., heating water to high temperatures until phase change occurs and steam is generated.

However, they are much smaller in size than industrial boilers, with capacities much lower than industrial boilers.

Their mechanical structure comprises SS316L due to the criticality of Steam application in pharma applications. The associated cements, such as gaskets, are also made of pharmaceutical-grade material to prevent contamination and compromise the quality of Steam produced.

The output of steam generator is pyrogen-free, and can be used for sterilization, Steam in place – SIP sterilization and to perform critical area humidification.

Some clean steam generators are attached to the equipment, as a part of it to fulfil equipment or process requirements without depending on the main supply. Their operation is controlled with the equipment, and their capacity only matches the equipment requirements.

In another type, steam generator is manufactured as a standalone equipment and installed in a centralized location to meet the clean steam requirements of the entire plant. Their capacity is often selected based on the whole plant requirement rather than a single piece of equipment. 

About the Author:

Muhammad Asim Niazi

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.