OEMs not familiar with packaging technology can easily get lost in a maze of possibilities. Add in FDA compliance and sterilization and the process can throw projects off track. But outsourcing packaging doesn't have to be a headache. Several contract packagers offer these guidelines to simplify the process.

When to outsource packaging

There are a few ground rules for deciding when to send packaging out instead of handling it internally. For instance, design teams should consider outsourcing when they have little packaging experience, are working on large-volume projects, or have complex products. “Packaging equipment is getting more expensive and people don't want to make that investment. But we will make the investment because it's our specialty,” says Marjanne Troost Meyer, Director of Manufacturing, Alcan Packaging, Bethlehem, Pa. (www.alcanpackaging.com). She adds that many manufacturers no longer have the in-house knowledge. “With so much downsizing in the industry, there's a lack of resources as well as expertise in certain areas, such as packaging and design. People turn to contract packagers for the expertise they've lost.”

Designers need also consider how far along they are in the development process. “Design teams often come to us when a product is almost ready for manufacturing,” says Chris Mazelin, Product Development Manager, Innovative Surgical Products Inc., Santa Ana, Calif., (innovativesurgical.com/mp). Most contract packagers would like to be involved as early as possible in the design process to ensure the product can be packaged as easily as possible.

There are certain qualities design teams should look for in a contract packager. “First, look at the number of years in the industry and experience with the products the company is making,” says Troost Meyer. “Does the packager have the appropriate packaging equipment available, and can they handle large volumes? Can they purchase more equipment quickly if necessary?” Also consider turn around time. How fast can they go from concept-of-design to start up? “Pricing is often an issue, but it's not always the first issue,” she adds.

Who handles what

The division of tasks between contract packager and OEM varies among companies. Package design at Alcan “is a team effort,” says Troost Meyer. “Ideally we want to be involved in the design early enough to ensure the finished product works on the equipment on hand. Quite often we'll run unusual designs past the equipment manufacturers to make sure the design is functional and feasible. We like to do that as soon as the design team has a firm concept. We'd like to be involved before they even get into any marketing or graphic design.”

William Leib, Senior packaging engineer with B. Braun OEM, Bethlehem, Pa., (www.bbraunoem.com), says that packaging design depends on “a number of things such as aging and ship testing, marketing input, and approval. We need OEM input because they might require special testing and maybe more.”

Material selection can also be a collaborative effort. “Sometimes designers research their own materials and come to us with requirements. But quite often we'll work with them and make recommendations on the different components that may be easier to obtain or easier to form,” says Troost Meyer.

The ultimate responsibility of FDA compliance is the owner of the product. “However, we have to make sure we are in compliance, equipment is validated, and the process follows good manufacturing practices. We document everything including training, SOP's for setting up machines, and validation protocols,” she adds.

Leib notes “the FDA regulates what we do regarding design controls, systems we use to measure our process, and makes sure we are in a controlled environment that produces safe products. We document everything we do through design and change controls. Our internal system generates engineering change notices and different kinds of documentation.”

Sterilization is often the next phase and may be handled by an off-site contract sterilizer. “Packaged products are either returned to the customer and they send it out, or we send it to a sterilizer,” says Troost Meyer.

Mazelin notes that sterilization is “dictated by the material and type of medical device. For example, silicones can be sterilized easily using several common methods. But printed circuit boards can't be gamma radiated because the radiation affects the circuitry.”

Helpful hints

The most common request from contract packagers is to get them involved early. “Doing so can save the OEMs a lot of time and headaches,” says Troost Meyer. “For example, if the design team wants a hexagon shape from a machine that can only handle rectangles or squares, they'll be disappointed.”

Mazelin from Innovative Surgical Products agrees. “I spend a lot of time telling OEMs to take a more realistic approach to timing. They don't fully understand the regulatory ramifications and the time it takes to do a lot of these things. For example, validating sterilization can take anywhere from six to eight weeks to go through all the necessary steps to assure that you have sterilized the product. Overlooking these things can kill a project.”

End use is something else to consider. “Designers usually come in with an idea that may or may not work,” adds Leib. “They may have a firm idea in mind and we have to negotiate on changes so the product can fit in our system. For instance, an OEM might send components to be packed with their products. Some packages will be too big or not user friendly, and we'll try to fine tune them and show how components should come out of the package. Often the medical procedure dictates the order which components should come out of the package.”

OEMs should also check standards. “We found ISO 11607 to be useful. It's titled Packaging for terminally sterilized medical devices,” says Leib. “It lists needed testing, required test methods, materials. and includes a glossary.”

Alternatives to Tyvek

Talk about medical packaging and the first thing that comes to mind is Tyvek. The packaging, made by DuPont, is the industry standard for good reason. Tyvek 2FS, 1059B, and 1073B are high-performance materials that can easily withstand sterilization methods.

For designers who want more than paper packaging but don't need the high qualities of Tyvek, there are a few options. Ovantex sterile-grade material from Oliver Medical, Grand Rapids, Mich., (www.olivermedical.com), is a synthetic, reinforced material with high puncture and tear resistance. “Ovantex fills the gap between the performance of Tyvek and cost of paper. For example, if you package millions of small devices that have no sharp edges, it makes sense to use Ovantex,” says Jeff Murak from Oliver.

Another alternative lying between Tyvek and papers are the polymer-reinforced papers from Perfecseal, Oshkosh, Wis., (www.perfecseal.com). “Engineers are discovering that they have over-engineered their medical-device packaging,” says Perfecseal's Chris Osborn. “A lot of people find they spec'd packaging that was more than what they really needed,” he adds. Perfecseal's packaging is offered in different grades, PS55, PS55A, PS75, and PS76, and is used for packaging gauze, IV starter kits, and tubing sets.

ISO 11607: Packaging for terminally sterilized |medical devices

Since OEMs are the ones responsible for FDA compliance, it helps to become familiar with some of the guidance. ISO 11607 specifies requirements for single-use materials and reusable containers used for packaging sterilized medical devices. The standard outlines principal requirements for packaging process development and validation for manufacturers. Forming and sealing are considered most critical. Other actions that can affect the final package are addressed. The standard provides guidelines for the most common practices and techniques. It also specifies criteria for evaluating package performance, including a framework of lab tests and evaluations that can qualify the overall package performance during handling, distribution, and storage.