The Importance of Tube Sets: Critical From Start to Finish
Biopharmaceutical manufacturing is complex and involves hundreds of components and processes working together. Manufacturers and vendors spend a lot of time designing and setting up state-of-the art processes to build active bioprocessing ingredients and refine drug products.
This article is posted on our Science Snippets Blog
Unfortunately, one small – but very critical – item is often left out of the discussion: tubing sets. These unobtrusive materials touch almost every part of the manufacturing process, but too often they are an afterthought in planning. This can leave manufacturers scrambling to get the right tubing and connectors. Or it could result in delays and errors that cost time and money. Thinking about tubing sets as an essential part of your manufacturing assemblies ensures that when production begins, your entire process is ready from start to finish.
There isn’t one universal tubing setup in biopharma manufacturing as specific needs can vary from one product, process, or manufacturer to another. Tubing sets include all the pieces that carry liquid from one manufacturing step to the next, such as:
These components all act as pieces of the puzzle, with each being just as important as the last. A critical step in any bioprocess is effectively putting these pieces together to meet specific requirements.
Admittedly, tubing assemblies aren’t the most exciting or glamorous part of the manufacturing process, but they warrant attention at every step of designing your facility and equipment process.
Why Tubing Sets Should Be in Your Planning Process
As end users work with suppliers to design bioprocessing solutions, tubing sets should be in the conversation from the very beginning. There are several reasons:
Ensuring Product Quality and Reducing Contamination Risks
Because tubing sets are part of every biopharmaceutical manufacturing process, they can impact the quality and viability of your final product. Tubing sets must not leach materials into the product or remove anything during the manufacturing process that could negatively affect the final product. They must also be tight to ensure that there are no leaks, particularly at the connections. As product moves downstream and you are dealing with increasingly pure – and increasingly valuable – substances, tubing set purity and efficacy matters even more.
Addressing tubing set needs at the early planning stages gives your engineering team plenty of time to ensure that the products are properly tested and validated in multiple situations and with multiple product types and raw materials. Waiting until the last minute to address tubing needs could leave you with options that are not fully vetted.
Biopharmaceutical manufacturing is a complex process that takes raw materials through multiple production phases to get to the final drug product. Products move through a maze of tubing and connectors. Waste in this process can happen in two ways:
- Contamination or compromised quality –Low-quality tubing materials or connectors could negatively impact the safety and efficacy of the final product. Compromised product that doesn’t meet regulatory requirements must be discarded. low-quality tubing materials or connectors could negatively impact the safety and efficacy of the final product. Compromised product that doesn’t meet regulatory requirements must be discarded.
- Leaks and product losses –In addition to finding the right materials, tubing sets must fit correctly into your entire process. Incorrect tubing and connectors could lead to product leaks that waste valuable raw materials in upstream or downstream processes.
Avoiding Manufacturing Delays
A final reason to address tubing sets early and often in your process is time. Speed to market is one of the most valuable competitive edges that a biopharmaceutical manufacturer has. Waiting too long to figure out your tubing needs could lead to delays for a myriad of reasons, including (but not limited to):
- Design time – Engineers or other team members may have to push out production timelines to revise production designs if the available or appropriate tubing set components do not meet their initial expectations.
- Supply chain limitations – Your preferred supplier may not have the right products, or enough in stock, to meet your immediate needs.
- Testing or validation delays – Your new tubing set may need additional testing and qualification before you can install it. This is especially true for downstream processes, where product quality must meet strict regulatory safety standards.
- Regulatory delays – For brand-new manufacturing processes, end users may get to the end of their planning stages only to realize that there is currently no tubing set available with the appropriate regulatory or biocompatibility tests. Production halts while your team or your supplier conducts the tests.
Next Steps to Get the Right Tubing Sets
Fortunately, there are simple solutions to these tubing set challenges:
Incorporate tubing set discussions at the earliest stages of production design
Ensure that every team member understands the importance of tubing sets in the entire manufacturing picture
Partner with a vendor that helps you design tubing sets to meet your requirements and specifications and provides all the necessary testing and validation to meet regulatory requirements