6 hacks to find the best tubing for your processes!

With the constant advancements in the world of biopharmaceuticals, biotechnology and more, there is no end to the diverse intricacies in the new process advancements and improvements today. Tubing has always been an essential tool in the transference of liquids, extraction of substances and other applications.

Depending on the application, there is a need to consider all factors of the tubing, such as flexibility, wall thickness, chemical resistance, performance, cost, and more. So how would you identify if one type of tubing will function better than another?

Here are six hacks on how to find the ideal tubing for your fluid transfer processes:

 

1. Nature of fluid used

The actual fluid used, for example, in single-use bioprocessing, vary from proteins or other biological media to strong pH adjusters and buffers. The primary concern for the tubing's impact on process fluids are biocompatibility, extractables & leachables, adsorption &absorption , permeability and external influences like ultraviolet light and gas.

How your process fluid interacts with the tubing would heavily affect the final product. For example, some tubing may contain animal-derived ingredients or silicone oils, resulting in a potential risk of negative reactions.

 Image result for biopharma lab

Understanding the fluids to be transferred is key to choosing the adequate tubing type. Acids and bases must be isolated within chemically compatible tubing, and on the other hand, if the biologicals used are sensitive to ultraviolet light or oxygen, it would require opaque or low gas permeability tubings.

 

2. Meeting the various regulatory standards

Image result for fda approved

Depending on the application, the tubing itself might require compliance to USP, FDA, ISO, European Pharmacopoeia, or other standards. Get to know about the conditions in which the tubing is manufactured, form of production, handling and storage before sales, and if any testing has been done to validate the product.

Request for a COC (Certificate of conformity) to validate that the tubing has undergone the necessary tests to ensure its suitability for the application. You can also check if the testing was outsourced to a third party or conducted in-house by the manufacturer. Without validated test certifications, you may put your products, as well as lives, at risk.

Documents, such as regulatory compliance, non-animal origin (NAO) status, and extractables studies should all be readily available upon request from the supplier.

 

3. Processing conditions

Processing conditions include parameters like temperature, pressure, time, and sterilization methods prior to use. Taking the temperature parameter as an example, most single use bio-manufacturing processes are conducted at temperatures below 40 °C, so most tubing options are compatible to meet this temperature requirement.

However, when it comes to certain Pharmaceutical and biopharmaceutical batch manufacturing processes, where the fluid or samples are frequently stored in small bags with attached tubing or within a section of the tubing itself, the process may require tube welding and/or sealing. In this case, tubing of a material composite like thermoplastic elastomers (TPE) will be needed to enable this welding/sealing mechanism.

Image result for quick connectors cpc

Another approach will be to enlist the usage of quick-connects or sterile connectors, and with this, the tubing selection will not be restricted to TPE material to meet the welding/sealing temperature requirements. Similarly, if the tubing is to be autoclaved, it should be resistant to at least 125 °C.

Operating pressure is also an important consideration, in order to select a tubing with the right size or reinforcement, for example, braided or wire reinforced tubings.  This is necessary to prevent leakages and therefore contamination and loss of product during operation. 

 

4. Sterilization

Several processes might require fully sterilized tubing, as such, the sterilization conditions must be considered when selecting tubing. Most single-use applications are mostly gamma irradiated or autoclaved.  With regards to pre-sterilized tubing, ensure that the supplier’s process has been validated to the degree of sterilization necessary.

 Image result for gamma sterilization

5. Peristaltic pump life

For such an application, your selected tubing needs to be able to withstand repeated compression and releases without losing its consistency, limit generation of particulates, and durable enough to last multiple hours.

Shore hardness is directly correlated to the wear and tear of pump parts - the harder the pump has to work, the shorter its lifespan. Some tubings are designed specifically for pump use, while others are made for a variety of uses. These factors should all be taken into account during the tubing selection process.

Tubing grades recommended for peristaltic pumping are typically qualified for much longer service than would be applied in most single-use applications, but failure to consider pumping suitability after sterilization can lead to significant problems as well.

 

6. Tubing Assemblies 

In certain situations, there would be procurement of many individual items to setup a whole assembly, leaving the process open to a lot of reconnections. Different tubing materials with various types of connectors to assemble might leave the process open to potential for leaks, contamination, as well as human error.

Image result for over molded tubing assemblies

Tubing materials such as TPE’s meet the requirements for peristaltic pump usage and can be moulded/ welded into certain configurations, further reducing the need for fittings and the possibility of leaks. One should always consider whether a tubing assembly may be used in your application.

 

 

Here at PureSys, we are the Ultra-Pure Fluid Transfer Specialists, working with renowned international principals to bring you the best and most reliable products to secure your processes. All our products come with a registered COC to ensure the quality requirements and specifications of the product. Check out our website and online store at www.puresys.com.sg today!

 

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