Case Study: Extending Tubing Lifespan Beyond Manufacturer's 1-Year Recommendation

Challenge

The manufacturer recommended replacing the biopharmaceutical tubing every 12 months, likely to drive frequent purchases. This short lifespan led to high replacement costs and production downtime.

Solution

We optimised cleaning methods, added mandatory drying, conducted monthly inspections to extend lifespan.

Results

Tubing lifespan reached 28.5 months (137.5% improvement), maintaining safe performance under operational conditions.

Benefits

  • Cost Efficiency: Reduced replacement frequency, cutting expenses.

  • Enhanced Productivity: Less downtime increased output.

  • Improved Safety: Regular inspections minimized failure risks.

  • Sustainability: Longer-lasting tubing reduced waste.

Case Study: Extending Medical Device Tray Lifespan with Rapid FDA-Approved Aging Studies

Challenge

Our medical device trays, made of copolyester with a composite film and adhesive, had a manufacturer-recommended 5-year shelf life, leading to frequent replacements and high costs. Traditional aging studies, taking years, were too slow to optimise material selection and predict long-term performance.

## Solution

We implemented an FDA-approved accelerated aging study, calculating aging rates and activation energies for the copolyester tray, composite film, and adhesive junction in weeks, compared to years for traditional methods. We evaluated various copolyester formulations for durability under simulated long-term conditions.

Results

The tray assembly lifespan extended to beyond the manufacturer recommendation, maintaining structural and adhesive integrity in accelerated tests completed in just weeks (as opposed to industry standard taking years)

Benefits

- Cost Efficiency: Reduced replacement frequency, cutting costs.

- Time Savings: Accelerated studies enabled rapid material optimization.

- Reliability: Ensured tray stability for extended use.

- Sustainability: Longer lifespan minimised waste.

Conclusion

Using FDA-recognised accelerated aging, completed in weeks, we extended our medical device tray lifespan to 6 years, enhancing reliability, reducing costs, and promoting sustainability.

Here are some critical products we have defined useful lifespan for.

GULSINE’S NICHE EXPERTISE IS TO QUICKLY AND PRECISELY UNDERSTAND HOW PRODUCTS / MATERIALS WILL BEHAVE IN THE LONGER TERM AND WHETHER IF THE INTENDED LIFESPAN IS SUITABLE FOR THE CRITICAL PRODUCT.

You synthesised a new biopolymer and you would like to compare it against synthetic counterparts.

GULSINE is happy to test one sample for free and demonstrate it over A2P2 for academic institutions.