ISO 11607-1 Medical Device Package Testing

As a leader in medical device package testing, Keystone Compliance provides full guidance and support throughout the certification process. Our certified test experts thoroughly understand the requirements of ISO 11607-1. Through our proven process, package validation is streamlined in a step-by-step manner.

Request a quote to learn firsthand why so many companies partner with Keystone Compliance to meet their medical device pack testing needs. Our ISO-11607 experts will provide valuable guidance throughout the process. If you are unsure of where to start, contact us. We look forward to working with you to help you certify your packages through our streamlined process.

The remainder of this document speaks to the ISO-11607 Packaging for Terminally Sterilized Medical Devices test standard.

Summary of ISO-11607 Package Testing Sterilized Products

The objective of this medical device package testing standard is to create a sterile medical device. This device should perform efficiently, effectively, and safely. ISO-11607 package testing covers the design validation requirements and the attributes required of the materials.

There are several goals of a terminally sterilized medical device packaging system. First, is to maintain sterility up until the point of use. Second, is to allow sterilization. Third is to allow aseptic presentation. Lastly, the goal is to provide physical protection.

The ISO-11607 medical package testing standard applies to several different areas. Each industry must meet specific ISO 11607 requirements. Health care facilities must adhere to the standard. Also, all other areas where medical devices are placed in sterile barrier systems and sterilized must comply.

Key Definitions

To understand this ISO 11607 package test standard, several terms must be understood. Included below are some of the defined terms included.

Packaging System: A packaging system is a combination of sterile barrier and protective packaging.

Preformed Sterile Barrier System: A sterile barrier system that is supplied partially assembled for filling and final closure or sealing. Examples can include bags, pouches, and reusable open containers.

Protective Packaging: Materials designed to prevent damage to the sterile barrier systems and its contents. This protection is to last from the time of assembly to the point of use.

ISO 11607-1 Transit Performance Testing Overview

The package system is exposed to several hazards during testing. These hazards can include shock and vibration. Compression, temperature and humidity testing can also be conducted. Pressure changes can be in the scope of work. The modes of transportation can be considered.

All performance testing is completed on a worst-case basis. For instance, what is the worst-case sterile barrier system. The worst case protective packaging should also be tested. Stability testing is also completed. These ISO package tests can show integrity over a period of time.

The unit under testing must provide acceptable protection to all sterile barrier systems and its contents through the hazards of handling. Test types carried out during ISO 11607 standard compliance testing include the following:

Transportation Simulation: Transit tests are tests that are designed to challenge the capability of a package and its product to withstand transportation hazards. The test utilizes a general simulation of actually transported packages. ISTA Series 3 lab transit tests are designed to provide a laboratory simulation of the general damage-producing motions, forces, conditions, and sequences of transport environments.

Temperature / Humidity: This test type evaluates the ability of a package to protect a product when exposed to various test cycles of temperatures and relative humidity. ISTA 7E is a new version of the 7-Series tests that evaluates the effects of external temperature exposures of individually packaged products shipped through a parcel delivery system.

Seal Strength: This type of testing evaluates the relevant opening force of flexible materials and package integrity. Keystone recommends testing to ASTM F88, Seal Strength Testing of Pouches and Flexible Materials for all of your seal strength compliance test needs.

Bubble Leak: Bubble leak testing evaluates gross leaks and the breaching of sterile barriers through internal pressurization. ASTM D3078 and ASTM F2096 detect gross leaks and bubble emissions in flexible packaging.

Dye Penetration: Similar to bubble leak testing, dye penetration testing detects channels formed in package edge seals.

Visual Inspect: It is recommended to visually inspect all sterile barrier systems after testing to determine if breaches in the sterile barrier system are evident.

Basic ISO 11607-1 Standard Compliance Requirements

It is important that the source and history of all materials are known. This is true of recycled materials as well. This ensures consistency over time. During ISO 11607 package testing, a number of conditions are tracked. The temperature range, pressure range and humidity range are recorded. Also recorded are the maximum rates of change for those three variables.

Exposure to sunlight or UV light is also evaluated. The cleanliness and bioburden are tracked. The electrostatic properties are also observed during the test. Materials must meet certain requirements. Materials are defined as wrapping materials, paper, plastic film, non-woven, and reusable fabrics. All materials must be free of cracks, creases, holes and tears.

There can also be no thickening or thinning that impairs functionality. Materials must be clean. They should conform to minimum physical properties. These are just a few of the many ISO 11607 requirements materials must meet.

The design of a sterile package is key. Packaging systems must be designed to minimize safety risks. The product should be received by the patient in an aseptic manner. Health risks need to be minimal. The packaging system must be protective. It must allow for sterilization. There are also strict labeling requirements.

Keystone’s ISO 11607 Medical Packaging Equipment and Capabilities

The initial step is the development of the test plan. Our team evaluates the packages and products to assist in determining the best course of action. It is essential that packages not be over or under-tested. With our knowledge, the optimal test plan and sequence is finalized.

The second step is the ISO package integrity certification testing. Our lab features dozens of temperature chambers, several shakers, several drop testers, and other pieces of test equipment. This fleet of equipment permits immediate scheduling and limited backlogs. Our communication throughout the package testing program is constant.

The last step is the documentation guidance. With multiple report writers, we can turn concise reports around quickly. We pride ourselves on our report accuracy and timeliness. We can also assist in the submission of documentation for regulatory validation.

Expert Medical Packaging Testing to ISO 11607

As an industry leader in package testing, Keystone Compliance can meet all of your package testing needs. Our team understands the requirements. We streamline the process. Receiving ISO-11607 certification can be challenging. Let us walk you through our proven process.

If challenges arise during testing, our transit testing engineers provide valuable guidance and recommendations. With years of experience, we have the knowledge and resources to suggest solutions. This consultative approach has substantially driven our record growth.

Request a quote to experience the Keystone Compliance difference. If you have questions, contact us. Rely on our expertise to guide you to pharmaceutical package testing and medical device package testing.

For more ISO package transportation testing standards, follow the links below: