Pharmaceutical Tubing & Fittings

Tubing and fittings are part of a piping network in a Pharma facility that delivers the essential fluids at the point of requirement. The special thing about pharma tubing is that since the fluid they deliver comes in direct contact with the product, it must be approved according to the process and regulatory requirements to prevent creating complexities in the product. This contrasts with other industries, where no specific product requirement is considered – only the process-related specifications and guidelines are implemented.

In simple words, tubing and fittings are part of the piping network that runs throughout the pharma facility. It helps  in supplying different fluids through various sections, processes, areas, and equipment.

What are tubing and fittings?

Tubing is the hollow structure that provides an enclosed path for fluids to flow. Unlike pipe, tubing is not threaded at its end and requires a metallic structure called fitting to couple with another tube, instrument, equipment, or any metallic structure.

Their length varies and depends on their manufacturing process and condition. Their different sizes are joined to form a piping network across the pharma facility at every critical requirement.

Applications

Pharma tubing and fittings are widely used in pharma facilities and become an integral part of Pharma process equipment. Some of them can be described below.

Utility supply

Tubing and fittings supply utility fluids for many applications and processes. The main reason for using Pharma grade tubing is that fluid often comes in product contact during processing, and to prevent contamination and impurities in a pharma product through tubing, pharma-grade versions are used.

Like other industries, utilities are delivered at high pressure for various process-related reasons. For this reason, tubing and fittings must be able to bear the high pressure associated with these fluids. They must be strong enough to prevent rupture, explosion, and leak in tubing due to high pressures.

Some of the utilities supplied are described below.

Steam

Steam is an everyday utility used in the Pharma industry in direct and indirect product contact applications.

For applications where steam comes in direct contact with the product, it is supplied in pharma-grade tubing and fittings that help to provide product-grade purity levels. For other non-product applications, steam is supplied in non-pharma grade piping.

Compressed air

It is a pressurized air that functions a specific machine part or component inside it. In some processes, compressed air comes in direct contact with the product. This application uses Pharma-grade tubing and fittings to deliver compressed air. These tubing and fitting run across the pharma facility and drop at the desired distribution point.

Product Supply

Pharma tubing and fittings are also used to supply products at the target location because their material of construction poses no or little threat to the product, such as due to

·        It does not react with the product (chemical)

·        Tubing and fittings are resistant to rust and material degradation

·        They are also unaffected by high temperatures associated with different products

·        They are highly resistant to various aggressive environmental conditions such as dust, different gases, and moisture

The product is contained or stored in a Pharma facility in a centralized location. From there, it is distributed to the target point of operation, such as filling machines and manufacturing vessels, through these tubing and fittings.

Instrument connection

Tubing and fittings are also used to connect various instruments and gauges for pharma process monitoring because they provide a convenient connection to the equipment. Additionally, process instruments and gauges have small openings or connection points, which can be easily provided by tubing and fittings.

In this application, the instrument or gauge is first fixed to an appropriate tubing and then connected to the equipment. It also enables instruments having different opening sizes than the equipment port to be easily connected to the equipment.

Water treatment plant

The water treatment plant is critical for every pharma manufacturer because water is the basic raw material used for every pharma application. For this purpose, it has strict compliance requirements, mainly to prevent water from contamination, and one of them is to use pharma-grade tubing and fittings in all the processes, attachments, accessories, instruments, and other related components.

Tubing and fittings have a great application in water treatment plants and are used to connect instruments, valves, and metallic structures. Tubing is also used to connect different sub-sections of water treatment plants with each other and is used as a major piping application. For example, they are connecting raw water intake with the pre-filtration section.

The main advantage of pharma tubing and fittings is that they help retain water purity by providing favorable conditions and preventing water contamination from sources such as piping walls, rust, and material degradation.

Some applications in water treatment plants, where tubing and fittings are used, include the following

·        Connecting instruments and gages for monitoring process to various components and parts of a water treatment plant

·        Different sampling points to take the water sample to check the water quality

·        For dosing different chemicals into the running water for process requirements

·        In the Storage tank, connect valves, instruments, and with the plant, vessels, and distribution system

·        Interconnecting different subsections of plants

Clean-in-place system

A clean-in-place system is an attachment to the pharma equipment to clean it without detaching part of the equipment or removing the entire equipment from its place. It uses an automated system comprising many parts, including the tubing and fittings.

Tubing and fittings are usually used to carry the washing fluid through spray nozzles that spray it at every corner and part of the equipment.

Additionally, tubing and fittings are used below equipment for drying after washing.

Like in other equipment, tubing and fittings are critical to the success of the cleaning cycle. All cleaning agents and solutions must remain clean and free from contamination, and this can be achieved by using appropriate pharma-grade tubing and fittings.

Types of fittings

There are a number of types of tubing and fittings available for use in the pharmaceutical industry, mainly depending on the piping network, area of deployment, and process applications. Some of these are described below.

Tri-clamp hose adapter

Tri - A clamp hose adapter is used to connect the tri-clamp with a horse end, which is then used to connect sanitary fitting or hose pipe. The hose pipe is often threaded to provide a solid grip for the attached pipe, prevent slippage, and leak the fluid from a hose pipe.

They are commonly available in 90-degree bends and reducing adaptors.

Automated weld ferrule

Automated weld ferrules are ferrules that have longer lengths and can be used to aid in welding by providing extra space.

Tri-clamp concentric reducer

Try clamp concentric reducer, a two-sided clamp with differently sized openings. It is used to connect larger pipes on one side with smaller pipes on the other side. These reducers are commonly used in applications where piping is vertically installed.

Tri-clamp end caps

As the name suggests, these are the caps in a threaded fashion. They are used to seal or close the process lines to prevent the ingression of any particles into the tubing and piping.

90-degree elbow

The 90-degree elbow is tubing that is bent at 90 degrees. It is used to connect two pipes 90 degrees apart from each other. Its main function is to change the direction of fluid flow.

Tri-Clamp Short Outlet Reducing Tee

Tri-Clamp short outlet reducing tee has three openings – two at both ends of the tubing and one at its center. It is used to connect three pipes.

Pharma requirement

For the pharma industry, tubing and fitting must be of pharma grade because the pharma industry has strict demand and cannot rely on ordinary grade fitting and tubing.

Some standard requirements for Pharma grade tubing include the following.

Surface finish

The surface of the tubing must be smooth without any roughness. Because coarse and rough surfaces are the primary source of contamination in the tubing. These rough surfaces can reside and hide bacteria or contaminants in them. These harmful substances are also challenging to eliminate, even with cleaning.

Surface finish is measured in a unit called Roughness Average – Ra, and its value for Pharma grade must be 0.51 micrometer (where tubing is mechanically polished) or 0.15 Ra( where the tubing is electropolished). A higher value of Ra indicates a rough surface, and vice versa.

Stainless steel

The tubing and fitting for pharmaceutical applications must be made of stainless steel, and its approved variant is 316L. The low carbon composition variant of stainless steel provides benefits unique to Pharma process requirements.

Its advantage is that its chemical composition and properties remain the same when interacting with the pharma product. SS 316L also prevents rust inside the tubing, a common problem with metallic structure that interacts with liquid or water.

Orbital Welding

If welding is required on any tubing or fitting, the welding used, must be of orbital type. This welding welds a joints simultaneously from both sides i.e. form inside and outside.

Its advantage is that there are no any dead points created in the weld joints, which eliminates facilitating of any contamination, foreign particle and microorganism in the vicinity of welding point.

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.