In this webinar, John Litz, Business Development Manager at ILC Dover, explores key factors in selecting the right tubing for biopharmaceutical manufacturing. He examines the critical considerations that impact tubing performance, including material selection, size, pressure ratings, and compatibility with various processes. John discusses how different tubing formulations—such as silicone, TPEs, and reinforced hoses—affect durability, chemical resistance, and suitability for specific applications like pump operations and aseptic welding.
John also highlights the importance of quality requirements, including biocompatibility testing, extractables analysis, and cleanroom manufacturing standards, ensuring that tubing meets the rigorous demands of biopharma workflows. He answers audience questions about tubing longevity, kinking prevention, and the role of material properties in optimizing fluid transfer. This webinar underscores ILC Dover’s commitment to providing high-performance solutions for bioprocessing, offering valuable insights into how selecting the right tubing can enhance efficiency, reliability, and compliance in pharmaceutical manufacturing.
Watch the video or explore the transcript below to learn more.
Transcript
Introduction
[Shannon Stultz] 0:21– Hello everyone, welcome to today’s live broadcast: Key Buying Factors for Tubing Used in Biopharmaceutical Manufacturing.
I’m Shannon Stultz, Senior Editor of Special Projects for BioPharm International, and I’ll be your moderator for today’s event.
We are pleased to bring you this webcast, presented by BioPharm International and sponsored by ILC Dover. ILC Dover is a world leader in the innovative design and production of solutions for biotherapeutic, pharmaceutical, and medical device markets, as well as a leading supplier for the aerospace industries.
Its customers will attest to the company’s relentless dedication to high-value products, advanced technology, and responsive services. ILC Dover’s visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.
We have a few important announcements before we begin. This webcast is designed to be interactive, and we encourage you to ask questions during the event. You can submit questions by typing them in the Q&A box, which can be found at the bottom of the video player.
You can enlarge the slide window by clicking on the small icon in the bottom right corner of the media player. The slides will advance automatically during the event. If you have any technical problems viewing or hearing this presentation, please click on the question mark help button in the top right of your presentation window.
I would now like to introduce today’s speaker. We are pleased to be joined today by John Litz.
John Litz is a Business Development Manager at ILC Dover who has 10 years of experience in the bioprocessing space, in both production and commercial roles. He obtained his degree in Biological Sciences from Salisbury University in Maryland.
He began his career with Lonza Scientific shortly after graduating, and since 2015, he moved into a commercial role and has held various responsibilities in business development, product management, market research, and single-use fluid transfer assembly design.
Thank you so much for joining us today, and please get us started.
Choosing the Right Tubing
[John Litz] 2:17 – All right, thank you, Shannon. I really appreciate the introduction, and I guess I’ll get started now.
So, the main goal here of this presentation is essentially helping everyone here choose the right tubing for their process.
So, let’s get started.
The Value of the Right Tubing
[John Litz] 2:36 – Choosing the right tubing—tubing is much more than just a piece of plastic that you utilize within your process to move fluids, right?
There are various materials that can really help you be successful in your process. And those materials aren’t just standard plastics, right? You might have silicone, you might have TPEs, you might have different types of thermoplastic rubbers.
But all tubing is not going to be the same. Every application calls for a different type of tubing to ensure success, right? The right tubing can really make or break your ability to maintain a closed system and help your assemblies from leaking.
Because leaks, in the end, when it comes to tubing, are not what we want. We want to make sure the system remains closed so all that bulk drug product can be recovered and ultimately moved forward into the final fill for vials.
Tubing Applications
[John Litz] 3:35 – So, moving forward—some of the typical applications where you might see tubing in bioprocess.
Generally, if you’re going to be starting upstream, you’ll be looking at your cell culture and expansion. Generally, this is done with smaller-sized tubing.
As you’re going through scale-up, your tubing will continually increase in size, generally as you move to larger vessels.
Moving forward from cell culture and expansion, you can have different types of tubing in your production and harvest systems, whether that be a standard unreinforced tube or a braided hose.
With filtration and chromatography, given their higher pressure applications, you’re most likely to see some type of braided hose. Generally, those are going to be silicone.
For buffer and media preparation, generally, this is just going to be your standard fluid transfer. There may be some pumping involved, so you might need specialized tubing for pumping.
Then again, in any type of single-use fluid transfer assembly—right? These can be bioreactor kits, assemblies for tangential flow filtration, or final fill assemblies with pump tubing, filling needles, etc.
Tubing is also very, very closely integrated into bag manifolds for storing bulk drug substance. And again, touching on filling—smaller tubing is used in sampling, as well as in process development and laboratory use.
Here’s just a quick graphic on where tubing might be used in your process.
You can see upstream here—you’re going to be starting with your cell seeding and cell expansion. You’ll be adding media, and that’s all going to be happening with tubing.
As you move from your wave bag or storage bag to your bioreactors, you’ll see scale-up where you’ll use different sizes of tubing, potentially depending on the size of the reactor.
Moving forward, if you’re using specialized single-use centrifuges—I know Coriolis Biosciences makes a great single-use centrifuge with tubing assemblies—you might have something directly attached for your centrifugation.
Moving forward to your filtration applications in the downstream area—now, in downstream, you’ll have higher pressure applications for your filtration and chromatography.
In those different applications, you’re going to see buffers added, you’re going to see a lot of different types of tubing—whether that be, again, specialized pump tubing for continuous processing applications, braided hose for any type of high-pressure application utilizing magnetic flow-head pump heads, or even just sometimes general unreinforced tubing.
Whether that be silicone or TPE for different types of applications—say, in TFF, you have your permeate and retentate lines—that’s where you might see something that’s unreinforced.
Moving through TFF to bulk formulation, you’ll generally see your standard unreinforced tubing there.
As it leaves in the final fill, you would have some pump tubing in an assembly with your filling needles, which would go into an isolator and do the final fill into your vials.
Physical Considerations
[John Litz] 6:37 – So, what are some of the physical considerations for choosing the right tubing?
One of the first things that you might think of when it comes to tubing is the tubing hardness, right? And that’s represented by durometer.
The general measure for durometer is going to be what is called Shore A. There’s also Shore D, which is generally used on more rigid tubing like a fluoropolymer, but Shore A is primarily what you’re going to be seeing in the bioprocess industry.
So, when we say a tubing is a 50 durometer or 50 Shore A, that’s going to be softer than something that’s 80 Shore A durometer.
Within different applications, you might need a higher durometer or a lower durometer, just depending on what you’re doing with the tubing, right?
If you’re going to be handling higher pressures but not something that requires the pressure requirements of a braided hose, you might use a product that is a higher durometer—like an 80 durometer—because it can withstand higher pressures than something like 50 durometer.
If you’re going to be pumping, you’re generally going to see tubing in that 50 Shore A to 60 Shore A durometer range.
Again, with that being said, durometer is something that’s very important to pay attention to because it can affect the outcome of your application. It can affect the success of your tubing in your application.
I mentioned pumping—generally, in those cases, when you’re choosing tubing, you’re going to want to make sure that the durometer fits into what you’re looking for. If the durometer is too high, at very high durometers, you might be more likely to see a split in your tubing during pumping.
Moving forward—some of the next physical considerations you might have are tensile strength and elongation.
Tensile strength is essentially the max stretch before the tubing will snap or break.
Elongation is the change in length after force. So, if you’re pulling on that tubing, how likely is that tubing to stay at the new length from the force that was applied?
Touching on deformation of tubing, next, we’re going to be moving to modulus and compression set.
Modulus is the resistance to deformation from force. Modulus can be very important for pump tubing applications because you’re going to want to make sure that it has good resistance to deformation.
One thing that you’ll commonly see in pump applications is tubing compression.
Essentially, when you think of tubing, you think of a circular inner diameter that helps maintain consistent flow rates.
In certain cases, if you have tubing with an inappropriate modulus or compression set, you might see ovality occur on the tube, which can affect flow rates and the success of the tubing in a pump application.
Now, moving forward, the next thing that you’re going to be looking into—especially if you’re doing pumping—is pump life, right?
That’s pretty self-explanatory—how long will the tubing last in a pump before failure?
That’s definitely something that is going to become more important as we see more applications like perfusion continue to rise on the market.
Sometimes, specialized pump tubing can be necessary, with pump lives anywhere from 1,000 to 10,000 hours.
Another factor that I actually don’t have listed here is spallation, and that again goes into pump applications, right?
Spallation is particle shedding, and it can happen if you are seeing continuous hits on your tubing from your roller-head pumps.
Choosing a tubing with little to no spallation is going to be preferable so you don’t have tubing particles ending up in your drug product.
Next, we are going to be looking into pressure ratings.
Why is pressure important? Understanding what your pressures are is extremely important to your application.
If you’re running pressures that are too high for a standard unreinforced tube, you might have leakage, or you might have tubing rupture.
Now, with higher pressures, there are special tubing options available—especially hose options—that generally have braid reinforcement to ensure that the tubing can withstand your high pressures.
If you’re running at low pressures, you can just use a standard unreinforced tube without much of an issue.
And lastly, shelf life.
Shelf life is just going to be the lifespan of the tubing before use, and that can include both gamma radiation shelf life or your standard shelf life.
In most cases, what I’ve seen in the industry, you’re generally going to see a shelf life on silicone tubing of anywhere from 3 to 10 years, with the general average being around 5 years.
Post-gamma, more likely, you’re going to see a shelf life of 2 to 3 years.
Tubing Size
[John Litz] 11:30 – Onto tubing size.
This is something that might not be at the forefront of your mind when you’re initially looking to choose your tubing. You might be thinking of materials, you might be thinking about your process, but picking the right tubing size is integral.
It’s going to be very important when you’re integrating your components of choice into your assembly with your tubing. Tubing size isn’t just important for selecting connectors or filters—it can also affect how your process moves forward.
If you use smaller tubing, you won’t have the same flow rate as you would with a larger tubing size. This can increase or decrease your flow rate and impact your filling speed.
Some of the typical tubing sizes you might see—though there are many more not listed here—include:
- 1/8 inch
- 1/4 inch
- 3/8 inch
- 1/2 inch
- 1 inch
Each of these sizes has its place in different areas of the process. For example, if you’re doing sampling, you might be using a small sampling port with a smaller-size tube. If you’re performing pumping upstream during scale-up, you might use something like a 1/4-inch ID or 3/8-inch ID.
Further into the process, when handling larger-volume fluid transfers, you’ll typically see larger ID tubing, such as 1/2 inch, 3/4 inch, or 1 inch.
Another key consideration when selecting tubing size is the actual size number, which may not always be straightforward.
In certain cases, when using a pump, you might have a specific roller head number. Ensuring you have the right tubing size for that particular pump head is crucial.
Some of the commonly used tubing sizes in pump applications include:
- Size 16
- Size 24
- Size 73
These are three of the more frequently used sizes in both pump applications and other areas of upstream and downstream processing.
Choosing the Right Materials
[John Litz] 14:01 – Choosing the right materials.
I touched on this briefly at the beginning of the presentation, but when it comes to choosing the right material for your application, it can really be a make-or-break factor in how successful you can be when running anything upstream or downstream.
Generally, when thinking of the more commonly used tubing in the industry, you’re probably going to think primarily of silicones or TPEs.
TPEs are thermoplastics, whereas silicone is a thermoset material. Silicone has been around in the industry for quite some time—it’s essentially the tubing of choice. It’s very commonly used throughout all areas of the manufacturing process because of its proven industry success.
It’s also a very versatile offering with great chemical compatibility. It’s highly durable, and there are multiple formulations available on the market for various applications. Silicone tubing isn’t just for general transfer—you can also get pump formulations, reinforced silicone like braided hose (which I’ll touch on later), and even temperature-specific formulations for applications like cold chain storage.
Moving forward from silicone to TPE, the two most notable TPEs on the market at the moment are C-Flex and AdvantaFlex. Sometimes, when people are looking for TPE tubing, they might specifically ask for C-Flex or AdvantaFlex because they are industry leaders.
In general, TPE is a thermoplastic elastomer tubing. One major difference between TPE and silicone is that, since silicone is a thermoset material and TPE is a thermoplastic, you can manipulate TPE with heat, whereas you can’t do that with silicone.
One primary application for TPE tubing is aseptic sealing or welding. This is a great use case, especially if end users don’t want to use costly aseptic connectors but have welding or sealing capabilities for disconnection and connection. In those cases, TPE would be the right choice.
Some TPEs on the market today are also specially formulated for pumping, with pump lives that can last 1,000 hours or more. Since pump life is a critical factor in choosing tubing, it’s important to recognize that different materials offer different performance levels.
Lastly, there’s chemical compatibility. I’ve listed chemical compatibility under TPE instead of silicone because different materials react differently to chemicals. In some cases where silicone might not be the right choice, TPE could be an alternative.
Chemical compatibility is critical in ensuring tubing doesn’t degrade during processing. Certain chemicals—whether caustic or acidic—can affect tubing differently, so selecting the right material is essential.
Moving on to PVC.
PVC has been more or less phased out of the bioprocessing space because it’s viewed as a lower-purity material. One reason for this is that some PVC formulations use plasticizers, which are undesirable in bulk drug substances because they can leach into the product.
However, PVC is still a legacy material in the industry. While not as commonly used as it once was, it still has applications, particularly in lab settings and process development.
One of the main benefits of PVC is its low cost. But while cost is a factor, it’s not necessarily the most important one. In most cases, having high-quality tubing that meets process requirements is far more critical, which is why many people choose silicone or TPE over PVC.
Moving on to specialty formulations.
There are tubing formulations on the market beyond silicone and TPE. These include TPVs (thermoplastic vulcanizates) and TPRs (thermoplastic rubbers).
These materials are often used in pump applications because they offer exceptional pump life—some lasting up to 10,000 hours or more.
They also tend to have good chemical compatibility ratings. When selecting tubing, pump life is an essential factor, and TPVs and TPRs provide superior longevity compared to standard silicone.
Composite materials are another option commonly found on the market.
A key example is Sta-Pure tubing, which is a specialty formulation that can withstand very high pressures with little to no particle shedding (spallation).
Sta-Pure tubing also has an ultra-long pump life of over 10,000 hours.
Some composite materials combine silicone with PTFE. In these cases, the PTFE might be manufactured into a scaffold, with silicone filling the gaps to form the composite structure.
This type of material is especially useful in pumps, where high pressure and extended use are required.
Temperature-specific formulations have become more prevalent in recent years, particularly with the rise of cold chain logistics in the supply chain.
These specialty formulations are designed for cold storage, refrigeration, and freeze-thaw applications.
Their primary benefit is their ability to handle extremely low temperatures without compromising the tubing’s physical integrity.
In freeze-thaw applications, tubing is often the weakest link, as it can become brittle and crack. Specialty formulations prevent these issues by maintaining flexibility and returning to their normal shape after being bent.
Now moving forward to hoses.
There is actually a difference between tubing and hose. The key difference is that a hose is a reinforced tube.
The manufacturing process also differs. Tubing is typically manufactured in a single pass—extruded, inspected, coiled, bagged, and ready for use.
With a reinforced hose, the process involves multiple steps. First, the inner liner is extruded. Then, it is placed on large stainless-steel spools and run through a braiding machine that applies the reinforcement. Finally, the hose is passed through the extruder again to add the outer jacket.
Braid-reinforced hose is primarily used in high-pressure applications. While most are made from silicone, there are braided TPE hoses available as well. These can be substituted for silicone when chemical compatibility issues arise.
One of the most common applications for braided hose is tangential flow filtration (TFF) and other downstream filtration processes where high pressures are required to push material through membranes.
If a braid-reinforced hose isn’t sufficient for the required pressure, you might need a wire-reinforced hose.
Wire-reinforced hoses are highly durable and typically feature both wire and fabric reinforcement.
While they are generally made from silicone, they are available in a variety of materials for different industries, including bioprocessing, food and beverage, and brewing.
These hoses usually have large inner diameters and are designed for high-pressure bulk fluid transfer.
A standard braided hose may have an ID of around 1 to 1.5 inches, but wire-reinforced hoses can range from 4 to 6 inches or more.
However, these hoses are typically not considered single-use. Instead, they are autoclaved after initial use and reused in the process.
Finally, one last reinforced hose you might encounter is fluoropolymer-based.
Fluoropolymers include PTFE, PFA, and FEP. These materials are highly chemically inert, making them ideal for applications where silicone or TPE would not be suitable.
If your process involves aggressive chemicals that are caustic or acidic, fluoropolymer hoses are the best choice due to their superior chemical resistance.
Quality Requirements
[John Litz] 25:27 – Now we come to the quality requirements you might require around your tubing.
Industry-wide, there is a lot of overlap in what is tested. These regulations ensure the tubing is pure, safe for use, and won’t introduce contaminants into the bulk drug substance throughout the upstream or downstream manufacturing process.
One of the main tests you’ll see is biocompatibility testing, which is generally done according to the ISO 10993 method for biological reactivity in medical devices.
ISO 10993 is actually a series of multiple tests—there are more than 20 in total—not all of which apply to tubing. It is a very rigorous testing series that ensures tubing is safe for drug manufacturing.
Some other common tests are USP (United States Pharmacopeia) tests. The most commonly seen is USP Class VI, which is a biological reactivity test similar to ISO 10993. That regulation falls under USP Chapter 88.
Another biological reactivity test often seen in conjunction with USP 88 is USP 87.
Additional tests are conducted on the finished product, such as endotoxin testing.
You don’t want endotoxins or cytotoxic materials in your tubing. These could affect overall product viability and yields.
Other important USP standards include:
- USP 661 – Packaging and materials of construction, ensuring the material used in tubing has high purity.
- USP 381 – Testing for elastomer closures.
- USP 788 – Particulate testing.
All of these tests are performed on ILC Dover tubing, and you’ll see them applied to most commonly used tubing in the industry.
Moving forward, we have EP (European Pharmacopeia), which is similar to USP.
In some cases, there is overlap between the two. If you’ve completed USP testing, you may be able to leverage it to fulfill European Pharmacopeia testing requirements as well.
The three most common EP standards in the industry are:
- EP 3.1.9 – Used for testing silicone closures and tubing.
- EP 3.2.9 – For elastomeric closures, which may apply to silicone, TPRs, or TPVs.
- EP 3.2.2.1 – For plastic containers, often applied to thermoplastic elastomers or TPE tubing.
It’s also important that your supplier has good inspection procedures for tubing extrusion.
Inline sampling ensures tubing meets specified tolerances, including ID, OD, length, and wall thickness.
Visual inspection is also critical to detect any particulates.
At ILC Dover, we conduct 100% visual inspection over a light box so operators can confirm there are no visible or subvisible particulates in the packaging or the tubing itself.
Next, and arguably the most important quality requirement for many, is extractables testing.
There are two primary extractables testing methods used in the industry: BioPhorum Operations Group (BPOG) Testing and USP 665 Testing.
These methods differ, and the choice depends on the user’s needs.
BPOG testing is highly in-depth, using six solvents over multiple time points. It follows more of a one-size-fits-all approach for different bioprocess components.
USP 665 testing focuses on three solvents with individual time points based on the risk level of the component. Components classified as high-risk or low-risk have different exposure time points for these solvents.
Physiochemical testing evaluates material purity and detects contaminants.
Some common physiochemical tests include specific gravity measurements and modulus testing.
Another critical requirement is ensuring tubing is animal-derived ingredient-free to prevent contamination risks such as BSE (bovine spongiform encephalopathy) or TSE (transmissible spongiform encephalopathy).
EMA 4101 certification is commonly used to confirm that tubing is free from these contaminants. This certification is a standard in the industry.
The next consideration is gamma stability.
If you need gamma-radiated or sterilized tubing, it’s important to ensure that the tubing material won’t degrade during the gamma radiation process.
Most tubing is typically exposed to 25 to 45 kGy of gamma radiation for sterilization. However, most tubing on the market is tested up to 50 kGy to ensure stability within the standard sterilization range used by companies like Steris or Sterigenics.
Finally, there’s cleanroom certification.
Tubing should always be cleanroom extruded—you don’t want tubing manufactured in an uncontrolled environment.
Ensuring tubing is produced in a clean space helps mitigate contamination risks and ensures process integrity.
The most common standard for tubing extrusion in bioprocessing is ISO Class 7 cleanrooms. Some products may be manufactured in ISO Class 8 cleanrooms, but ISO Class 7 is generally the industry standard for bioprocess component manufacturing.
Choosing a Supplier
[John Litz] 31:54 – So, choosing a supplier—how does one go about choosing a supplier when there are so many different manufacturers and distributors on the market?
Tubing is becoming more of a commoditized item, so it really depends on what you’re looking for. In certain cases, if you’re developing a full process with hardware systems, bags, and other components, it might be best to choose an end-to-end solution provider that can supply all of those items as you develop your process.
If you’re facing issues with certain types of tubing in your application and need different formulations for specialty applications, you might want to look for a supplier with extensive experience in tubing and a broad range of formulations, including silicone, TPEs, TPRs, TPVs, and braided hoses.
These products can typically be purchased either directly from manufacturers or through distributors.
In my experience, if you’re using smaller quantities, distributors might be the best route. Distributors such as Cytiva or VWR, as well as local distribution channels within specific regions, are great options for smaller orders.
Local distributors provide on-site support and can sometimes offer more favorable pricing on smaller quantities than manufacturers or end-to-end solution providers.
Quality systems are another critical factor when choosing a supplier.
You’ll want a supplier with a validated quality process, typically certified to ISO 9001 or ISO 13485.
ISO 13485 was initially developed for medical devices, but due to its stringent requirements, more companies in the bioprocessing industry have adopted it.
I touched on this earlier, but it’s essential that your supplier has certified cleanrooms, ideally at ISO Class 7.
It’s also important to ensure that the tubing is produced and packaged within those cleanrooms.
Generally, all products should be double-bagged.
Single-bagged products are acceptable if they won’t be transferred into a clean space, but in most cases, double-bagging ensures that when you remove the outer bag, there’s no risk of particulates entering your clean space.
Another critical requirement is lot traceability.
If a tubing failure occurs, you need to be able to trace it back to a specific lot. This allows for immediate action, such as recalls, if necessary.
Lastly, validation guides are extremely valuable for end users when specifying tubing.
A validation guide consolidates all required information in one place, making it easy for users to access and verify product specifications.
Location is another important consideration when selecting a supplier.
You’ll want to choose a manufacturer in a geographically convenient location and from a trusted place of manufacture.
For example, if you’re in North America, you may prefer a North American manufacturer. If you’re in Europe, you may look for a European manufacturer to reduce lead times and logistics costs.
Number of sites is another key factor.
If a force majeure event occurs and shuts down a manufacturing site, having multiple production facilities ensures continuity of supply.
Manufacturers with redundant production capabilities can continue delivering products to users without disruptions.
Reliable supply is critical.
During COVID-19, many integrators, manufacturers, and users faced supply chain issues, leading to inconsistent delivery dates.
One of the most common problems was delivery date fluctuations, where dates moved up, moved back, or were completely unpredictable.
If delivery dates are inconsistent, it disrupts campaign planning and affects overall process timelines.
Ensuring reliable supply with consistent delivery schedules is essential for maintaining process efficiency and avoiding unexpected delays.
As a user, having dependable supply ensures you can plan your bioprocess runs without hiccups.
Lastly, we come to price and lead time.
When selecting a supplier, it’s essential to find competitive pricing that aligns with your budget and process needs.
Lead time is another crucial factor.
Everyone wants their product as soon as possible. If a supplier has long lead times, they may not be the best fit at that time.
In some cases, a similar product with shorter lead times may be available from another supplier.
Ensuring you can get the product quickly and efficiently is key to maintaining smooth operations.
Here’s an example of how ILC Dover ensures supply reliability.
Over the years, we’ve made several strategic acquisitions, one of which was Flexan—a leading tubing extruder in the medical device industry since 1946.
Today, we have multiple manufacturing sites, each specializing in different tubing types:
- Salt Lake City – Primarily TPE extrusion, with two extrusion lines.
- Lincolnshire – Silicone extrusion, with five extrusion lines.
- Juarez, Mexico – A new site with the capability to add redundant manufacturing capacity.
By having multiple production sites, we ensure that our users have multiple avenues to receive the product they need, reinforcing supply reliability.
Q&A
[John Litz] 38:21 – Great, and that’s the end of my presentation. So let’s open it up now for any questions.
[Shannon Stultz] 38:28 – Thank you so much, John, for that informative presentation. Before we get started with the question-and-answer session, I’d like to remind our audience how to submit questions.
You can submit questions by typing them in the Q&A box, which can be found directly below the video player.
Our first question is: Can you elaborate on the differences between extractables testing?
[John Litz] 38:45 – Yes. The two main extractables tests I mentioned earlier are BPOG (BioPhorum Operations Group) and USP 665 (United States Pharmacopeia 665).
USP 665 is a public standard for drug manufacturing, whereas BPOG is not a public organization but rather a collaboration of major industry players establishing extractables testing requirements for risk mitigation.
BPOG testing involves six solvents commonly used throughout upstream and downstream manufacturing, tested at various time points up to 70 days.
When looking at long-term storage applications, such as bags or bottles, extended time points make sense. However, for tubing, shorter time points may provide more representative data for real-world applications.
USP 665 testing uses three solvents over single time points based on the risk level of the component. Higher-risk process components, such as tubing, have different time points and requirements than lower-risk items like bottles or bags.
[Shannon Stultz] 40:14 – Thank you. Can you do the same for the differences between TPE and silicone?
[John Litz] 40:22 – Yes. The major difference between TPE (thermoplastic elastomer) and silicone comes down to material properties.
Silicone is a thermoset material, meaning that once it’s extruded and formed into tubing, it cannot be re-shaped.
When exposed to heat, silicone retains its form, making it stable for high and low temperatures.
TPEs, on the other hand, are plastics that can be melted and re-formed in different ways.
One of the most common applications for TPE is heat welding or heat sealing for aseptic connections and disconnections—something you cannot do with silicone.
[Shannon Stultz] 41:08 – Thank you. How would you respond to someone wondering what material to choose for their tubing?
[John Litz] 41:13 – It really depends on the application.
If you’re running a perfusion process for 90 days, you’d want TPR (thermoplastic rubber) or TPV (thermoplastic vulcanizate) tubing.
A great example is Pharmed BPT, which has a pump life of up to 10,000 hours. If you’re running an extended 90-day or 45-day campaign, you need specialty pump tubing for that.
If you’re performing general fluid transfer, silicone or TPE may be suitable, depending on factors like pressure, temperature, and chemical compatibility.
[Shannon Stultz] 42:07 – Great. On to our next question: How do you prevent a tube from kinking?
[John Litz] 42:13 – Kinking is a common issue, especially in bioreactor tubing kits, where a filter within the tubing can cause collapse due to insufficient wall thickness.
If you experience kinking, it affects flow rates and prevents optimal process performance.
There are a few ways to prevent kinking:
- Use tubing with a greater wall thickness – This helps support components like filters in bioreactor kits.
- Use flow bend clips – These act as an exoskeleton to hold the tubing in a rounded shape, preventing collapse at bends.
[Shannon Stultz] 43:30 – Thank you. On to our next question: What causes spallation or pump tubing failure?
[John Litz] 43:36 – Spallation can be caused by several factors, including:
- Material selection – If the tubing isn’t designed for pump applications, spallation can occur prematurely.
- Extended use – Long-term use in a pump can lead to particle shedding on the inner and outer tubing surfaces due to continuous compression from the roller heads.
Pump tubing failure typically occurs when the incorrect tubing size is used. The tubing is pumped beyond its lifespan, causing rupture. A braided hose is used in a peristaltic pump—which can delaminate and fail.
[Shannon Stultz] 44:40 – Perfect, thank you. It looks like we have time for one more question: What happens if someone picks the wrong tubing?
[John Litz] 44:45 – In many cases, there is some overlap between tubing materials.
If you’re using silicone for general transfer, and there are no concerns with chemical compatibility or pump life, you might be able to swap in a TPR or TPV without issues.
The biggest concerns when choosing the wrong tubing are:
- Pump life applications – Extended pump use requires specialty formulations.
- High-pressure applications – Using the wrong tubing can lead to rupture or failure.
- Temperature-specific applications – If tubing isn’t designed for freeze-thaw stability, it may crack or break.
- Structural requirements – If tubing is too thin, it may collapse under weight or pressure, leading to flow restrictions.
Fortunately, most unreinforced tubing offers some flexibility in applications.
[Shannon Stultz] 45:59 – Great. Thank you so much for your time today.
With that, it looks like it’s time to wrap up. I want to thank the audience for attending and participating in today’s event.
I’d also like to thank our sponsor, ILC Dover, for making this educational webcast possible.
Before we go, we’d like to ask the audience to participate in a brief survey, which will appear on your screen after the presentation ends.
You’ll also receive an email notification when the webcast is available for replay. We encourage you to share it with colleagues who may have missed today’s live event.
We hope to see you all next time. Thank you, and goodbye.
