Design and Validation of Innovative Prototypes for Effective Sealing of PP Sterilization Wraps

Abstract

The sterile packaging of instrument trays containing medical devices is a critical step in the sterilization process for various medical and industrial applications. This process involves wrapping instrument trays with nonwoven polypropylene sterilization wrap, which plays a crucial role during and after sterilization. Traditionally, the loose ends of the wrap are secured using autoclave tape. However, the presence of this tape poses a risk of recycling contamination when the wraps are disposed of for recycling. Additionally, in some cases, the autoclave tape has been found burnt at the end of sterilization due to excessive use during the packaging process. This study aims to design and develop a prototype sealing device that eliminates the need for autoclave tapes while maintaining the integrity of the sterile barrier system. During this study, two prototypes of sealing devices were developed: one utilizing ultrasonic sealing technology and the other using impulse sealing technology. The ultrasonic sealer is sourced from a cold-fusion sealer, while the impulse sealer is obtained from a plastic packaging device. Both devices are upgraded and repurposed as per the drawn-up requirement specifications and development criteria. To validate the prototypes, a product characterization test is conducted optimizing the seal time settings based on seal strength tests following ASTM F88/F88M-21. The optimum seal strength, measured using the T-peel test, is determined to be 1.21±0.05 N/mm for the impulse sealer and 0.93±0.08 N/mm for the ultrasonic sealer at the optimized seal time for a test sample width of 30 mm. This is succeeded by, a demonstration of the prototypes at Maastad CSA in Rotterdam, assessing the usability and functionality of these devices. During the demonstration sealed sterile packages were made following a standard envelope-wrapping approach. Replacing autoclave tapes with the seals at the critical points to secure the wrap. Feedback is collected from employees regarding the new method of packaging. Two sealed sterilization packages produced following the use of both prototypes are subjected to a trial run in an autoclave for sterilization testing. The seals proved to be effective in withstanding the sterilization process without compromising the package's integrity.
The results of this study contribute to sustainability efforts in the healthcare sector by offering a more efficient and environmentally friendly approach to maintaining the sterility of reusable medical devices.