Sterile Connectors in Pharmaceutical Industry

Single-use technology is the new trend in the pharmaceutical industry, where an entire component or any part is designed to be used for a single time. After their single use, they are discarded and are not used again.

For another process, another single-use component is used to execute the next process, which is again discarded upon completion of the existing process. Single-use technology is implemented for several machine components, and one of them is a connector.

Connectors in pharma processing are used to connect different fluid paths spread across various parts in a machine or the undergoing process. Sterile connectors are just like a normal connectors, and serve the same purpose, but the difference is that they are build and guarantee sterility level, no matter what class the 

external working environment is. They can be used for several equipment, such as Vessels and valves, in which the fluid flow is involved.

What are Sterile Connectors?

Sterile connectors are ordinary type, except they connect different single-use components during pharma. It maintains and ensures sterility of the fluid, even if the processing environment is not classified. 

The primary function of sterile connectors is maintaining sterility, made possible by their unique construction and design by replacing conventional seal methods, and using latest & innovative methods to prevent contamination.

An example of such components is a membrane with the latest solid plugs(not present in traditional connectors) that protect the fluid when exposed to non-sterile environments in bioprocess applications.

Recent developments have enabled single-use connector applications in both upstream and downstream processes, equally matching both process requirements. They can provide efficient flow without any obstruction, with the desired purification level.  

Various variants of sterile connectors allow selecting a particular type for a specific application.

Physical Characteristics of Sterile Connectors

Single-use connectors have dedicated and unique physical characteristics that separate them from ordinary connectors, which depend on the application type and the output capacity of the underlying process.

Let's discuss what a typical single-use connector includes in itself.

• The single-use connectors come in various connection types and diameters to enable their application in multiple process requirements. The most common shape is a circle with a specific diameter, allowing a particular amount of fluid to flow through it. 

• They are provided with a mechanical lock to fix the connection and prevent it from being accidentally opened during or before the process. It locks the two heads of connectors and can be unlocked when required. 

• They are designed and manufactured to cater high-pressure applications, with high sealing capacity and prevent leakage during operation.

• Single-use connectors come in two configurations- Gendered and Genderless. 

The gendered configuration is divided into male-female configurations, provided with male and female coupling sets, and adjusted with each other. In genderless configuration, the connector halves are divided into equal shapes that can fit with each other without any special design requirement.

• Single-use connectors are also provided with an O-ring to seal the connection point and prevent fluid leakage from the side of joints. The construction material for O -the O-ring is usually Silicon due to its non-destructive and non-reactive nature with the pharma product. Additionally, some other materials can also be used for constructing the O-ring, which is also safe for the product

Depending on various design factors, some manufacturers may use gaskets for containment purposes.

How would you choose single-use connectors for your applications?

It has been a while since single-use technology has gained acknowledgment and traction in the pharma industry, and many options exist. However, selecting an appropriate connector for your application is critical to the success of single-use systems. 

Below are some considerations when choosing single-use connectors for your application

Flow

Flow is the fluid flow across a particular section of equipment to which a connector is used. Like other single-use systems, connectors must be selected from a pool of options that match the process requirements. The connector must tolerate the force exerted by the fluid to prevent leakage, damage, or blockage in the fluid flowing through it.

For a single-use connector application, determine or identify the amount of fluid flowing through a connector and match that specification during procurement.

Some manufacturers use pressure instead of flow to determine the fluid capacity of the connector. The pressure specifications can also be determined during the product development stage or obtained through appropriate documentation.

Tubing

Connectors are connected to the tubing to complete the fluid path and transfer fluid across different equipment parts. The tubing often changes its size and dimensions as it enters different equipment parts to cater to the flow requirement. 

Concerning the connector's tubing application, determine the size of the attached tubing and its dimensions (such as inner and outer diameters). Some tubing uses separate measurement standards from other measurement units.

The connection type of tubing is also a critical factor in selecting the connector type. Common types include Hose Barb and Push-to-Connect. Diameters are also considered when determining the connection type. 

Fluid Material

The fluid material is the chemical compound, bioprocessing, or pharma product used in equipment with single-use connectors. Above all, the material for processing equipment must be non-reactive to the product being used. It must tolerate all product characteristics and prevent damage, such as material degradation or any change in its material properties, and it remains the same for single-use connectors.

Look out for connectors that are well protected against the chemical effects of drug products. Connectors must be compatible with product properties such as Chemical composition and viscosity. 

Connector accessories, such as O-ring and gasket, must also be considered before selecting a single-use connector and must be chemically compatible.

When selecting connectors for particular product, it is also necessary to determine the material that best suits the production capacity. Selecting a product compatible connector, that affects the total productivity is not a good idea.

Temperature

It is typical for the drug product to be at different temperatures during manufacturing due to many product-specific requirements. At one time, they may be at high temperatures; at other times, they can be at much lower temperatures. For this reason, the product switches between temperature ranges during the manufacturing cycle. For the single-use connector, temperature ranges affect the construction material of a connector, since they are made up of non-metallic material.

 When selecting a connector, determine your product temperature requirements. Connectors come in a standard temperature range, and connectors of different temperature ranges may be used within a single equipment. 

Pressure

Pressure is the force exerted on the connectors due to many factors within the equipment. One factor is the output capacity of equipment, and the other is material characteristics such as viscosity. The connectors selected must not hinder the output rate or total productivity.

Always check for the pressure requirements before selecting connectors for your application or equipment, and determine what pressure will be exerted by the material flowing in it. Indicated in PSI or Bars, they provide data about the maximum pressure-bearing capability of a connector, and can be a helpful reference during product selection.

How integrity is maintained in single-use connectors

This section briefly presents the advantages of single-use connectors over traditional connectors in ensuring integrity. 

Less inherent contamination

Traditional connectors use welding to attach a stainless steel connector to processing equipment to provide a path for fluid flow. In welding, material cutting and heating at high temperatures are involved, which affects the material's strength and can introduce harmful particles into the equipment and, finally, into the drug product. 

Single-use connectors do not use the welding process at any manufacturing stage. Instead, they are subject to non-heating techniques, and afterward, they are sterilized before being packed. These and similar manufacturing processes make them an ideal candidate for applications with a high degree of containment.

Less human error

Human error in the pharma and bioprocessing industry is lethal and can damage the company's reputation and market share. For traditional connector-based systems, humans perform the majority of tasks that are prone to human errors. 

Additionally, conventional connector-based equipment is often complex to integrate, apply, and use. It usually requires skill, training, and experience to use them correctly. 

Single-use connectors are easy to use & flexible in their design, allowing operators to quickly adapt them for different process requirements. As a result, operators make fewer errors, minimal leaks, and less product contamination during connection-making between different equipment parts. 

Additionally, flexibility allows them to avoid additional components such as clamps, that causes and increases the process complexity and the chance to increase contamination or product leaks

Less time to connection

In traditional equipment, welding is used to connect connectors with the different equipment, which takes several minutes to complete. Additional steps, such as cleaning and decontamination, are also required to prepare the equipment for the process. It also engages the personnel until the connection is finalized and the equipment is ready.

Single-use connectors, on the other hand, require less time. It takes seconds to make the connection without additional steps such as cleaning, sterilization, and testing. It reduces the time needed to prepare equipment for the process, increasing productivity and benefiting the organization.

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.