Sterile and Nonsterile Packaging

Once a medical device has been designed, tested, and approved, it must be delivered. The design of packaging material is an important step in the development of products. Packaging will need to physically protect the device during distribution and, in some cases, maintain the sterility of the device.

Nonsterile Packaging

Some medical devices do not require sterile packaging due to their nature or the fact that they will be sterilized after being opened at the delivery site. Such devices need packaging that protects them from the hazards of transportation and storage. A device in transport may be subject to changes in temperature, vibration and shaking, and droppage. The device may experience periods of low air pressure due to air transport or high compression caused by the stacking of boxes. Our packaging conforms to the highest standards to provide protection against all damaging forces.

Sterile Packaging

Certain medical devices—such as the instruments used by paramedics in the field—must maintain their sterile condition during the entire period of transportation and storage. These devices are intended to be used straight out of the packing. In addition to protection against physical damage, the packaging for these devices must also protect against contamination.

The requirements for maintaining sterilization mean that the packaging itself must be free of contaminants and must provide an environment that protects the device from external contamination. Factors such as package integrity, the materials from which the packaging is made, and the quality of seals each play a role and must be tested. Some devices may be stored in their packaging for extended periods of time, so it is important to ensure not only that the package is structurally sound when first made but also that it is able to maintain the stability of the device during its recommended shelf-life.

Package Testing

All our packaging is tested to ensure it provides the protection required by the devices it holds. Sterile packaging conforms to ISO-11607, Packaging for Terminally Sterilized Medical Devices. Our testing procedures include aging processes, distribution simulations, seal integrity and strength checks, and stability tests.

When possible, long-term protection is checked through the use of real-time testing. Given the rapidity with which new devices are developed, however, this is not always possible. In such cases, accelerated aging tests can be used to simulate extended storage.