Medical Device Link.

A common refrain heard in IVD manufacturing is, “Oh—packaging. We’ll deal with that issue later.” Although scientists and engineers may be excited about the development of a new IVD, they tend to be less enthusiastic about dealing with the intricacies of the product’s package.

Nevertheless, packaging is important and should be considered early in product development. In fact, in the increasingly complex world of IVD technology, packaging and components have become more and more interdependent. Consequently, when contracting out the packaging of an IVD test kit, it is absolutely critical that the chosen manufacturer advocate a team approach.

As an IVD test kit manufacturer begins its search for the right packaging manufacturer, it will need to determine and prioritize its packaging goals. In general, the goals of IVD packaging are to ensure that the integrity of the materials and components of the IVD test kit are maintained and that the packaging and labeling are easy for patients and clinicians alike to use and understand.

The following questions need to be answered when determining what type of package is required:

• What are the IVD test kit manufacturer’s expectations for the packaging?

• What type of packaging is required to protect the integrity and functionality of the IVD?

• What are the functional requirements of the packaging configuration?

• What are the QA and regulatory requirements for the project?

Following is a step-by-step guide that details the important factors to be considered when determining the packaging and labeling for IVD test kit materials and components.

Test kit manufacturer expectations

From the perspective of the packager, the most important step in determining the design and manufacturing process of packaging for IVD test kits is meeting with the test-kit manufacturer to determine its expectations. Contract manufacturers assume that the OEM’s expectations also represent the voice of the consumer. Most packaging manufacturers use a checklist to ensure that requirements of the project are clearly understood by all parties. The checklist includes the following items.

Where is the product being sold? Package labeling and language will change when kits are sold in different parts of the world. Governments have differing regulations regarding the items that must be listed on packaging for IVD test kits. Contract manufacturers need to understand the scope of the product market so that they can plan accordingly for different lines of packaging.

What phase is the product currently in? If the product is an early prototype, then buyers will be less concerned with final packaging. However, the final packaging design must be ready by the time the product goes to clinical trials. Another important question to ask is whether the product is an intermediate (further processing is required) or a finished (consumer-ready) medical device. Each type of product will require its own packaging.

What is the intended use of the product? Who are the end users? Does the product in the packaging configuration being discussed get passed on to the consumer? If so, how does that affect packaging requirements? If the product is a subcomponent, how will it fit into final packaging?

Product shelf life. How will packaging construction impact product shelf life? Are there certain packaging materials that could enhance shelf life?

Sterility. Will the product be sterilized? If so, what type of sterilization method will be used?

Storage requirements. Must the packaging protect the product from spikes in temperature, light, moisture, oxygen, etc.? What level of exposure to elements can the packaging handle?

Hazardous chemicals. Does the product contain any hazardous chemicals? If so, will there be special transportation requirements? How will that impact packaging?

What quality assurance systems does the manufacturer have in place? Is an audit of the manufacturer required? Are there any product-specific quality requirements for the packaging configuration?

Compositional construction: building from the inside out

Once the manufacturer has a good idea of the components of and requirements for its IVD test kit, it is time to engage an IVD test kit packager.

When meeting with potential packaging manufacturers, test makers are advised to pay attention to the questions the packagers ask. The first question an IVD test kit packager should ask is, “What material are you trying to package?” Once the IVD test kit manufacturer and packager define the material type and dosage format, the next topic to tackle is whether any special characteristics must be taken into consideration when determining the packaging. Of utmost importance to packaging manufacturers is the protection of increasingly sensitive IVD test kit components.

Light transmission. Exposure to light and UV rays can cause a chemical reaction in certain medical materials. There are plenty of polymer grades that have UV protection characteristics, and some flexible films and foils make good choices, too, because they serve not only as barriers to light but also to oxygen and moisture. To ensure that buyers have all the appropriate information needed to make a packaging decision, suppliers need to know as soon as possible if the packaging needs to protect the IVD kit components from light transmission.

Oxygen sensitivity. Similar to light transmission, exposure to oxygen can also cause an adverse chemical reaction and ultimately reduce the shelf life of the IVD test kit. Generally speaking, oxidation protection can only be achieved by using expensive high-barrier packaging materials. Oxygen barriers can also be coupled with special oxygen scavengers designed for healthcare packaging. Newer products are always coming out on the market, though, so test-kit makers should be sure to check with packaging manufacturers to make sure they have explored all possibilities.

Moisture sensitivity. Does the package need to ensure that the material maintains a certain level of moisture? Most IVD products require some level of moisture control, especially against humidity. Humidity can cause a myriad of problems that range from the aging and migration of adhesives to potential microbial activity. Desiccant products for the IVD industry are available in a variety of formats. Packaging manufacturers can certainly offer their best suggestion, but buyers should be educated on the type of desiccant product their application may require. Desiccant products are available as tablets, canisters, cap inserts, desiccant stoppers, desiccant polymer blends, and more. Desiccant polymers can be molded into packaging containers and closures, as well as device components in order to integrate desiccation within the device.

Sterilization. Once the IVD test kit manufacturer determines that sterilization is a requirement, a decision must be made regarding which type is most compatible with the kit. The five major types of sterilization include ethylene oxide (EtO), gamma radiation, e-beam, steam autoclave, and dry heat. Packaging manufacturers should be able to make suggestions regarding which type of sterilization will work for a particular test kit.

For instance, silicone gel adhesives, which are useful accessories in certain IVD test kits, have special chemical properties that must be considered when going through the sterilization process. In fact, most sterilization processes do not work on silicone gel adhesives. Dry heat adversely affects the polyurethane liners on the adhesives. Gamma radiation is detrimental to the adhesive properties of the silicone gel. Even small dosages will crosslink silicone gel adhesives, which, in turn, changes penetration and increases durometer and modulus. E-beam increases the durometer and modulus, and in extreme cases, the silicone gel adhesive will become discolored and brittle. So, in the case of silicone gel adhesives, the only viable sterilization option is EtO.

Of course, there are plenty of other materials that would adversely react to EtO. Therefore, the bottom line is that buyers should get advice from packagers and material manufacturers on the best type of sterilization to use.

End Function

Once buyers have had initial meetings with manufacturers and discussed expectations as well as material composition, the next step in the process is determining the end function of the IVD test-kit components.

Manufacturer. If the end user of the packaged component is an OEM that is going to add packaged IVD components to a larger IVD test kit, two major issues must be considered: integrity of components and where one packaging process stops and the next begins.

Ensuring the integrity of the IVD test kit components is critical, especially when an OEM is accepting packaged components from a variety of suppliers. With the many contamination scares that have occurred over the last few years, manufacturers are looking for new ways to ensure the integrity of their products. Consequently, tamper-evident packaging is on the rise, especially in pharmaceuticals, but it could be useful for some IVDs as well. Technological advances have made tamper-evident labeling widely available, and tamper-evident packaging is also becoming standard for bottles and vials.

Determining where one packaging process stops and the next begins is also an important consideration for a large IVD test kit manufacturer, and it is a step that is often overlooked. Best practices do exist, though. For example, Polymer Science packages a diagnostic-test-strip material for different types of patient monitoring, and the test-strip material is shipped to the OEM for final assembly and packaging. In this case, Polymer Science is not responsible for all the additional details that must be considered when packaging an IVD test kit for consumers. Nonetheless, the IVD test kit manufacturers put the company through a rigorous process to ensure that its packaging capabilities and processes meet with the test-kit manufacturers’ strict quality regulations.

In the end, the manufacturer agreed to have Polymer Science package the diagnostic-test-strip material in bulk with one additional consideration: each package had to include dessicants to ensure that the test-strip material was kept dry. Without the dessicants, the material would be ruined by moisture exposure.

Even when one small component of a much bigger IVD test kit is being supplied, packaging must be considered a high priority to ensure that the quality of the end product is not compromised.

Retail or Consumer. If the IVD test kit needs to be packaged and drop-shipped directly to retail outlets, many more details must be considered.

• Are the packaged materials easy for the consumer to use?

• How many components are included within the package, carton, or kit?

• What type of labeling or tracking is necessary for the components?

• What is the final packaging configuration?

Quality Assurance Requirements

All good suppliers will have a documented quality assurance system in place. Buyers should seek out the following elements to ensure that the labeling and packaging manufacturer meets company requirements.

Certification. IVD packaging suppliers should, at a minimum, be compliant with cGMP, ISO 9001- or 13485-registered, or both. ISO 9001—Quality Management Systems is a standard that provides a number of requirements that an organization fulfills to achieve customer satisfaction through consistent products and services. In addition, to meet the standard, a company must have a plan in place for continuous improvement of its quality management system.

ISO 13485 represents a comprehensive management system for the design and manufacture of medical devices. ISO 13485 can stand alone, but usually a company puts both ISO 13485 and ISO 9001 in place.

Depending on the circumstance, other certifications may be mandatory. For instance, if a sterile medical device is part of the IVD test kit, the packager may need ISO 11607 certification.

Documentation. Suppliers should have a documented quality manual and quality assurance program that is tailored to meet the challenges associated with packaging and labeling. Communication between suppliers and buyers regarding product specifications is essential because the resulting quality tests give buyers the information they need to ensure that the packaging is meeting both internal and regulatory quality requirements.

Teamwork and Communication are Key

Because packaging suppliers and IVD manufacturers have to work together closely to develop a useful IVD test kit for the ultimate end user, the patient, it is critical that buyers and suppliers develop a close working relationship. Since so much of IVD kit packaging overlaps with the production of the medical components themselves, teamwork, constant communication, and documentation are essential to the success of a product.