Accelerating Catheter Manufacturing with Impulse Heat Sealing
How one medical device manufacturer achieved a 65X faster process, greater sustainability, and, in the process, realized $800,000 in material savings.
From Convection Reflow to Impulse Sealing: A Radical Efficiency Leap
A global medical device manufacturer was using convection reflow systems paired with a custom FEP heat shrink film to weld catheter components. While effective, the process was resource-heavy and time-consuming; 200,000 cycles annually, each weld taking six and a half minutes and requiring a single-use consumable costing $4 per cycle in addition to the labor and energy costs of long cycle times in a cleanroom environment.
65X Faster Process
Seeking to modernize their approach, the manufacturer turned to PackworldUSA to explore impulse heat sealing as an alternative. With PackworldUSA utilizing TOSS® Technology, The Optimum Sealing System®, and PIREG® Temperature Control, the results were immediate and significant.
As the Senior Principal Manufacturing Engineer on the project explained, “We were able to eliminate the need for a custom FEP heat shrink consumable in our process. This allowed us to remove the dependency on an external supplier that could have supply chain risks. In addition, reducing the cycle time from over 6 minutes to 6 seconds gives our manufacturing facility peace of mind knowing this equipment has no impact on the overall capacity of the manufacturing line.”
Greater Sustainability
Eliminating the consumable FEP improved overall sustainability by reducing plastic waste and eliminating a fluoropolymer from the same family as PFAS chemicals like Teflon. This efficiency gain translated into more than 21,000 hours of cleanroom labor saved annually, freeing up personnel and production capacity.
$800,000 in Material Savings
With PackworldUSA removing the FEP consumable from the equation, the manufacturer reduced its exposure to supply chain risks, an increasingly important consideration in today’s volatile manufacturing landscape. This shift away from third-party material sourcing allows for even greater stability, predictability, and autonomy in production planning while translating into annual material savings of over $800,000.
For medical device manufacturers facing similar challenges, impulse sealing offers a highly controlled, efficient, and sustainable alternative to traditional welding methods.
A New Standard for Medical Sealing
For the catheter application, PackworldUSA supplied custom tooling to hold the components in place, paired with its modular sealing press. After testing the setup on PackworldUSA’s in-house machines, the customer quickly moved forward with purchasing three full systems, which are deployed across their facilities globally. Encouraged by the results, the company is now considering implementing the technology in other parts of its manufacturing process.
Technology That Solves for Medical Manufacturing
PackworldUSA’s impulse heat sealing technology offered benefits beyond speed and cost. It addressed a deeper set of needs specific to medical device manufacturing: process control, repeatability, and the ability to validate. In life sciences, manufacturers are often hesitant to change validated processes due to the regulatory burden of re-qualification. However, in this case, the performance improvements were so clear, and the solution so precisely controlled, that the investment in change was justified.
Unlike constantly heated systems that require 15 to 20 minutes of preheating, impulse heat sealing equipment is ready to run in under a minute. It also supports a cooling cycle after the sealing temperature and dwell parameters have been achieved, which is critical for producing hermetic seals with materials lacking good hot tack properties. Some components require that cooling step for functional integrity, but even when it’s not strictly necessary, it often produces a superior cosmetic finish.
With impulse sealing, only a thin heat band, about the thickness of a razor blade, is energized, allowing the sealing area to heat and cool rapidly. A focused heating area at sealing temperature only when needed reduces energy consumption and keeps tooling at lower temperatures for quicker handling if the need should arise. The precision of this method supports better overall product quality while making the process highly adaptable for medical device manufacturing.
Precision, Repeatability, and Validatability Powered by PIREG
A cornerstone of impulse heat sealing’s suitability for medical device applications is its unmatched temperature control. For a process to be validatable, it must be consistent and measurable, which is only possible when heat can be precisely applied and accurately tracked. PackworldUSA’s Series impulse heat sealers achieve this through their PIREG Temperature Controller, which calculates and monitors temperature in real time using electrical resistance.
Instead of relying on thermocouples, which are slow to respond and often deliver inaccurate readings due to misalignment, PackworldUSA with TOSS Technology reads the electrical resistance of the heat seal band directly. The system takes 50 to 60 measurements per second, translating those resistance values into real-time temperature data via Ohm’s Law. This provides the kind of fast, accurate feedback loop required to maintain tight process control over short cycle times. The result is a level of repeatability and consistency that meets even the most stringent requirements for medical manufacturing while reducing the overall energy footprint.
