ISO 11607 Package Validation

The process of validating terminally sterilized medical equipment is outlined in ISO 11607. This standard ensures that medical device packaging systems maintain sterilization and provide physical protection. The ISO 11607 package testing standard is a requirement for all packages seeking compliance with the European requirements in order to obtain a CE Mark. The FDA also recognizes this package verification standard as well.

Prior to digging into the standard, it is important to understand the definitions of some of the most common and important terms referenced in the standard. A packaging system is defined as a combination of a sterile barrier system and protective packaging.

A sterile barrier system is a minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use. Protective packaging is the configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.

Getting a little more specific, a preformed sterile barrier system is a sterile barrier system that is supplied partially assembled for filling and final closure or sealing. Examples of these can include pouches, bags and open reusable containers. Sterile fluid-path packaging is a system of protective port covers and/or packaging designed to ensure sterility of the portion of the medical device intended for contact with fluids An example is the interior of the tubing for administration of an intravenous fluid.

ISO-11607 packaging validation testing involves the following areas of testing.

Shelf Life Stability Testing (also known as accelerated aging and real time aging)

Accelerate aging testing provides insight into a packaging system’s performance while undergoing extreme conditions. These conditions can include extreme temperatures, humidity conditions, thermal shock and other environmental conditions.

The objective of this testing is to validate shelf-life claims. ISO 11607 defines the service life as the number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and safe for its intended use when used according to the labelling. The standard of reference for this testing is ASTM F1980 the Standard Guide for Accelerated Aging of Sterile Medical Device Packages.

Simulated Distribution or Transit Simulation

Simulated distribution package testing involves exposing the packaging system to the rigors of transit. This testing can include drops, vibration, compression, impact, shock and temperature extremes and changes.

By going through this process, manufacturers can identify potential issues with the packaging system. Knowing the weaknesses in a system and addressing them in the lab as opposed to in the field has many benefits. These include reduced damage, lower returns and improved customer satisfaction and reputation.

Seal Strength and Package Integrity

ISO 11607 defines a seal as a result of joining surfaces together by fusion to form a microbial barrier. Seal strength is the mechanical capacity of the seal to withstand force. Lastly, seal integrity is the characteristics of a seal to minimize the ingress of microorganisms.

There are a number of tests that can be used to evaluate the package integrity and seal strength. These tests include tensile testing, dye penetration, burst strength, tear resistance, puncture and bubble emission testing.

Keystone Package Testing is an expert in assessing sterilized medical equipment packaging. Our large ISO-17025 accredited test lab is full of test equipment including dozens of temperature and humidity chamber, shakers, compression machines and other test apparatus. This large fleet of equipment allows us the ability to provide short lead times on scheduling.

In addition to the ISO accreditation, the lab is also accredited to ISTA, Amazon, ASTM, Sam’s Club, General Motors, QVC and many other package testing standards. Our certified engineers and technicians have a thorough knowledge of the packaging validation requirements.

Our proven process has allowed us to be recognized as one of the fastest-growing test labs in the industry. We provide constant communication and guidance throughout the entire process. From the creation of a test plan to the issuance of the thorough test report, our experts provide the guidance and feedback manufacturers want.

If you are in need of medical package testing and the need to validate healthcare packaging, you came to the right place. Please request a quote to get started. If you are not sure of what you need, contact us and we can answer any package testing questions that you might have.