Valves for pharmaceutical applications

Valves are an essential part of process industries. They are used to control fluid flow across many components and systems. For example, valves manage water flow in a piping system from different sources, such as the main tank. The valves are installed at various locations depending on the requirement. The valve's working is controlled and regulated according to the process requirement.

The valve consists of a mechanism that obstructs fluid flow. The percentage of obstruction is controllable and can be controlled manually, pneumatically, or electro-pneumatically. 

Recent advancement in control automation technology has also enabled the valves to benefit. Valves nowadays can be controlled through automatic actuators, capable of taking commands from a controller such as Programmable Logic Controller – PLC. These actuators take input in the form of electrical signals and convert it into pneumatic signals. It enables the valves to make precise movements, which is critical to process industries. 

This allows controlling fluid flow automatically, without human involvement. And the entire pharmaceutical product life cycle can be automated from manufacturing to packaging. 

Valves Market Trends

The global valve market currently (2021) resides at USD 2.2 billion and is expected to grow at a rate of 4.5% up to 2.8 billion by 2026. The main factor contributing to the growth is the expansion of process industries globally. The introduction of automation is also one of the factors, as it enables energy efficiency reliability and increases control over process parameters. 

However, increased prices in raw materials are the main obstacle in its linear growth.

Pharmaceuticals have the most share in the growth in the valve industry. Valves can effectively produce safe and hygienic processes because safety and hygiene are essential in pharmaceutical industries.  

Among all markets, Asia Pacific has the most significant growth rate. The Asia Pacific region is witnessing increased growth in industrialization, and China has reported more growth in all Asia Pacific markets. 

Impact of COVID-19 on Valves 

COVID – 19 affected most industries and hampered their growth. As a result, the consumption of different components and systems also declined. However, some industries kept their development, and COVID didn't hinder their progress towards expansion. 

During the pandemic, the need for medication rose exponentially, especially those used to treat COVID. As stated above, the valves play an essential role in producing medicines; the valves industry grew rapidly. Many industry players saw pandemics as an opportunity and developed new innovative ways to increase revenue. 

Another reason for the increase in pharma production due to COVID- 19 is the valve's ability to provide contamination-free operations. Mainly valves are manufactured by using Stainless Steel. The SS offers excellent resistance to contamination. 

However, the valve market for some industries also dropped, for example, in the Oil & gas Industry. The price of oil decreased drastically and affected its growth. 

Another industry that uses valves is wastewater treatment. Valves are used to control different fluids such as Compressed Air and wastewater. The shutdown of daily life, and most industrial operations, decreased wastewater generation. As a result, treatment requirements were also reduced, which caused a decrease in the demand for different process components, including the valves. 

Applications of Valves in the pharma industry

Valves have an essential share in the manufacturing of pharmaceutical product life cycle. Their ability to operate and control the process without human involvement, contamination-free material of construction, and precise control over fluid flow have made them an ideal choice for the manufacturers of pharmaceutical machines.

Some pharmaceutical industry applications where pharmaceutical valves are commonly used include the following.

Utility Connections to the process machines

Process machines require utility supplies to operate their basic operations. These utility supplies run or activate specific functions, then achieve unique process characteristics.

Valves are used to control the flow of these utility supplies. The main controller monitors the actual process and releases the utility flow depending on the process requirement. 

For example, steam is commonly used in pharma sterilizers to achieve temperature. The main controller continuously monitors the sterilizer temperature, and depending upon the temperature, Open or Close the valve for steam. 

Filling Operations

The filling is one of the most essential and critical operations in a Pharmaceutical company. The filling is executed in injectable and Oral Liquid departments. 

Valves are an essential element of the pharmaceutical filling process. For quality and accurate filling process, the valve's working must be consistent throughout the filling process. Higher the response rate of the valves, the higher the filling accuracy.

The filling valves must prevent foreign bodies or impurities from entering the filled container. The construction material must be of approved material type, as the valves get direct contact with the pharmaceutical product.

The main controller or Programmable Logic Controller – PLC monitors the incoming containers on the filling station. As soon as the PLC detects the container, it signals the valves to start filling. The PLC also monitors the amount of fluid flowing through a valve to fill the desired quantity into the container accurately.

Water Treatment Plants

Water is an essential raw material in the pharmaceutical field, and not a single pharma operation can process without it. Water Treatment Plant is deployed in pharma industries to treat the incoming water and make it pure enough to use in pharma manufacturing operations.

Valves are common in water treatment plants and control the water flow in different sub-sections. The valve operation is fully automated without human involvement. The valves are operated based on process parameters such as conductivity and pH value. If the water has achieved the desired value of physical parameters, the water is then allowed to move into the next stage. Otherwise, the treatment continues until the required parameter values are achieved.

The valves are controlled through the main controller or Programmable Logic Controller – PLC. The PLC continuously monitors different process parameters. As soon as the water reaches the desired values, along with another parametric requirement, PLC signals the corresponding valve to start water flow. The valve remains open until the next stage fulfills its required capacity. PLC monitors the fill level by individual-level sensors. The PLC signals the valve OFF when the water fills up the next step.

Other applications of valves in water treatment plants include controlling the flow rate of chemicals, inlet water, rejection water, and outfeed water.  

Heating Ventilation and Air-conditioning – HVAC 

HVAC consists of many components such as Air Handling Units to process the incoming air according to the pharmaceutical production environment. It is used to control different environmental parameters such as temperature and humidity. 

Valves are used to control different utility supplies to the HVAC system, to process the air. Valves are also used to manage the air going into the AHU and the processed air coming out of AHU. The valves take command from the central controller or the PLC that continuously monitors the air through airflow sensors. The PLC gives the command to the valves to open or close, for the air to pass or stop.

Pharmaceuticals consideration for valves

The pharmaceutical industry is one industry that has strict quality requirements in selecting process components. Because pharma industry products directly impact human health and even can become fatal for humans. Secondly, regulatory bodies such as the FDA inspect closely the process being carried out. 

The regulatory bodies can issue a warning letter if it finds that process is not carried out according to Current Good Manufacturing Practices.

Valves play an essential role in the pharma process and require careful selection. Often, the valves come in direct contact with the pharma product, so there are some special considerations when selecting valves for pharmaceutical products. Some considerations for choosing the valves for pharma applications include the following.

Material of Construction

Stainless Steel is an approved material of construction for process components. No other material is allowed, nor can it be used. Otherwise, the regulatory bodies can issue a warning letter. The benefit of stainless steel – SS is that it does not react with any substances and is resistant to rust or corrosion. 

There are two categories of Stainless Steel for pharma components – SS316 and SS 304. Both types are resistant to corrosion and other material degradation, but SS316 is more suitable than SS304.          

SS316 is the most widely used type and is suitable for parts that directly contact the pharma product. A low carbon variant of Stainless Steel, called SS316L, is the advanced and improved version of SS316 and is also used in construction valves.

SS304 is used in parts of the valve that do not directly contact the product, such as the outer body. 

Sanitary Design

The valves manufactured for pharma applications must be of sanitary design. Sanitary design enables the valves to remain contamination-free and ensure a safe process. The main features of the sanitary design are easy cleaning, a polished surface, and without any dead points. The valve connection points should also be of a sanitary design to prevent contamination to the connecting system or piping.

Easy cleaning means the valves do not have any parts that are hard to clean and require specialized equipment for cleaning. An example includes a spring-less design, as the spring is often hard to clean. Secondly, tiny product traces can be entrapped, making cleaning difficult.  

Dead point occurs when the material becomes deforms. As a result, a small valve area resists flow, and the liquid or solution is entrapped in it. Dead points in valves also entrap the product and become difficult to clean. 

The surface of the valve must be smooth and polished. A smooth surface allows for easy cleaning prevents any damage to it. A smooth surface prevents the particle from penetrating the product and ensures contamination-free operation.

The sanitary design can be achieved by following standard practices.

· The seals must be compatible for use in aseptic applications.

· The surface finish must be at least less than <35Ra

· The valves must be draining types, particularly when the valves are required to be used in r Clean-in-Place (CIP) and Steam-in-Place (SIP) applications.

· The welding must also be compatible with aseptic requirements.

· The valve materials must bear high temperature so that they can be steam-sterilized

Continue to read: Types of valves

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.