Too often, packaging is not given enough consideration in the product development process and, as a result, manufacturers are left to resolve serious issues that could have been avoided if addressed earlier. This exclusive article outlines the steps that must be considered when developing a new or revising existing packaging for a medical device.

By Curtis L. Larsen, CPP

Used in virtually every form of sterile medical packaging, DuPont Tyvek is the material of choice for pouches and lidstock (shown here), as well as breather patches and headers for bags.
  • Regulatory concerns
  • Compatibility issues
  • Design and appearance
  • Manufacturing guidelines
In the introduction of ISO 11607-1:2006, the authors have written, “The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor.” The process is definitely complicated and should always be considered critical to the overall success of a medical device. After all, even the greatest medical device in the world does not become a medical product until it is properly packaged, sterilized, and labeled.

But developing a new packaging system—defined in ISO 11607-1 as a “combination of the sterile barrier system and protective packaging”—or making changes to an existing one can be much easier if you do the necessary groundwork in advance and have a detailed plan to follow.

To aid in the development of that detailed plan, this article looks at seven basic categories of activities that should be included. It is important to note that many of the activities listed here are intended to be performed concurrently. In addition, there may be instances where some activities are not required due to a specific situation. However, by referencing these seven categories, a detailed plan can be developed that will easily guide engineers assigned the task of creating the finished device packaging through the complicated process of developing packaging systems for terminally sterilized medical devices.
1: Obtain Voice of the Customer
It can be very tempting to rely on anecdotal information or to hold an internal brainstorming session to determine end-user requirements. Don’t make this mistake. Always get input from those who will actually use the product. Conduct focus groups, interviews, and/or surveys to learn what these end-users really want—and need—in a new packaging system. Input from the company’s sales and marketing team can be helpful, especially to gain a better understanding of competitive offerings, but this information is not a substitute for obtaining the voice of the customer.

After gathering this information, be sure to get approval from appropriate groups that will be affected by any design decisions, such as marketing, product management, and operations.
2: Review Regulatory Requirements
Be sure that all of the pertinent regulatory requirements are understood. If help is required, consult with the company’s regulatory affairs department. For the United States, review the U.S. Food and Drug Administration (FDA) Quality System Requirements and Good Manufacturing Practices. For Europe, review EN/ISO 11607. Although not required in the United States, AAMI/ANSI/ISO 11607-1:2006 and 11607-2:2006 are a part of the FDA recognized standards program and are harmonized global standards.
3: Determine Real-World Conditions
When choosing the materials and packaging design, it is critical that the real-world conditions that the packaging will be subjected to during distribution, handling, and storage are considered. This must include both physical and climatic stresses, such as shock, vibration, humidity, temperature extremes, and changes in altitude.
4: Define Product Package Requirements
The FDA requires a Master Product Specification (MPS) be written for every medical device. An often omitted element is a section on packaging. Be sure to include all the information gathered in categories 1, 2, and 3. It is also useful to define and document device fragility levels, language requirements, and unit(s) of sale package configuration(s).
The device shelf-life should be included in the MPS. Be sure that there is data on file showing that the packaging materials and seals specified will meet the established device shelf-life.
5: Select Materials
Before specifying materials, it is important not only to determine compatibility among the various materials being used in the sterile barrier system and in the protective packaging, but also to determine compatibility of those materials with the device itself and the manufacturing processes to be used.

A wide variety of products are packaged in pouches made of DuPont Tyvek and a medical-grade film.
Packaging materials and components suppliers can provide a wealth of compatibility data to aid in the selection process. Additional tests should then be conducted. Some of the things to consider include compatibility with the manufacturing equipment, sterilization process, and labeling that will be used. Finding out that the adhesive specified for a label is incompatible with the sterilization method is a minor problem when the discovery occurs during the materials selection phase. It can become a real nightmare when realized at a later date and time.

Although tooling may not be thought of as part of material selection, it is an important aspect. Work with the company’s sourcing department for help with pricing and vendor selection. Perform a first article inspection and approve vendor retained tooling, verifying that the requirements documented in the MPS are being met. Further, be sure to document all materials and component information.
6: Create Package Design and Verify Performance
Be sure to receive final samples of the medical device—not an early prototype—and all of the accessories and labeling that will be included before creating a package design. Just a minor modification in the size or shape of the device or the addition of an extra accessory could require a major revision of a package design and a resultant delay in the planned product introduction.

Don’t overlook the impact of labeling on a design. Remember, labeling includes the labels that are affixed directly to, or printed on, the package components, as well as any package inserts or IFUs. Be sure to evaluate the labeling stock and conduct shelf-life tests. In addition, approve prototype labeling tools.

Sterilization is another key factor that must be considered early in the package design process. Contact the in-house sterilization department or contract sterilizer to discuss the sterilization method that will be used and to document the process parameters. Then, conduct tests to ensure that the medical device and sterile barrier system can survive when exposed to the stresses induced by the sterilization process.

Conduct preliminary screening tests for the real-world physical and climatic stress conditions that were identified in category 3. Then, write a Design Performance Qualification Protocol that clearly documents how the testing and qualifying of the package design will be performed. List the specific pass/fail criteria. Be sure that the test methods used to examine the samples are validated for use. Don’t forget to include shelf-life testing in the overall development process. If necessary, redesign and retest until the package design meets or exceeds the established performance criteria.

Finally, write reports and compile detailed documentation of the packaging assembly and components. Be sure to include all drawings, parts lists, and custom assembly tooling.
7: Develop Manufacturing Process
To ensure that a design can be put into production, get involved in the package manufacturing decisions. Determine what it takes to assemble the package. Then, create an equipment specification document that details exactly what the packaging equipment needs to do. Work with the company’s sourcing department for help with pricing and vendor selection.

After the equipment has been selected and installed, validate the process and the software, if applicable. There are three major components to process validation: IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification).

During IQ, determine by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification. Be sure that all appropriate tooling is on the equipment. If printing inline, be sure that this equipment is also properly installed.

During OQ, identify and evaluate critical process parameters, along with their operating ranges, settings, and tolerances. Establish process control limits and action levels that will result in product that meets all predetermined requirements.

During PQ, demonstrate that the process will consistently produce acceptable packages under normal operating conditions.

A documented review and approval process, known as process certification, should be the final step of the validation process. Work with the packaging equipment production manager to determine the best layout for the production line and to create work instruction documentation for the operators. Set up training for the operators to be sure that they know exactly what needs to be done to put the design into production.
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Curtis L. Larsen, CPP, who has more than 35 years experience in sterile medical packaging, is a package engineering consultant for DuPont Medical Packaging. He is an active member of ASTM International Committee F02 Flexible Packaging, D10 Packaging, and F04 Medical and Surgical Materials and Devices. Larsen is past co-chair of the AAMI administered US sub-TAG for ISO/TC198/WG7-Medical Packaging. He was a co-author of the initial draft of ISO 11607 “Packaging for terminally sterilized medical devices” and has been active on the ISO task group for the past three revisions. Larsen can be reached at