Solving All Your Packing Issues

Packaging plays a key role in assuring sterility when it comes to medical devices and instruments, and the right heat seal is easily the most critical step in the process. The simple truth is that no matter how good your sterilization process is, if the seal is compromised, your products are at a significant risk, and that means real danger to the patients involved. A deeper knowledge of the standards involved may help you enhance your own process controls.

ISO 11607

Validating the heat sealing process is subject to ISO 11607, Part 2. It lists out the requirements for forming the seal itself as well as the assembly process involved when it comes to sterilized medical devices. The standard states that the objective is to ensure sterility is maintained to the point of use in a repeatable, reliable way.

The regulations have suggested that you can get a good heat seal with a bar type sealer or an impulse sealer, but the critical parameters involved are temperature, pressure, and dwell time. It’s essential, however, that those parameters be controlled, monitored, and documented on a routine basis.

The Right Equipment

While it’s clear that building the right process to ensure seals are in place for sterility, it’s also clear that the equipment you choose plays an important role in establishing the initial process. Fuji-Sotex can help. With a full line of impulse sealers to help your products reach patients fully sterile, we’re here to help your company do more while remaining fully compliant at all times. Contact us today to learn more about the options we have in stock ready for your factory floor or clean room right now.