Five Facts About Packaging

By: Joyce Laird and Yvonne Klöpping

Medical packaging covers an array of products ranging from peel pouches to blister packs and lidding materials. Whether you are outsourcing packaging services or buying packaging materials to assemble in-house, partnering with a company with a solid background in medical packaging should be your first priority.

Source a Full-Service Supplier

Packaging is one of the most critical steps in the medical device production process, especially when the products are sold as sterile products. “As a matter of principle, the company must be certified to ISO 9001 and ISO 13485,” says Heiko Kaczorowski of inpac Medizintechnik GmbH (Birkenfeld, Germany). And depending on where the product will be marketed, registration with Japanese authorities or experience with US FDA may be beneficial, he adds. Furthermore, the supplier should offer a full range of services, including assistance in packaging selection, design and validation, production of the packing materials and design and procurement of the sales packaging.

Look for Versatility

Because all packaging solutions are tailor-made according to the specific requirements of the customer, it is helpful to work with a packaging partner with a diverse background, says Dino Fumasoli, Sales and Marketing Manager at IL-MedTec AG, Ivers-Lee AG (Burgdorf, Switzerland). Things to assess when looking for a packaging partner, according to him, include the company’s level of technical proficiency, its tooling, printing capabilities, packaging machinery, certificates and cleanroom environment.

Have Specifications Ready

As in all outsourcing, it is important to provide your business partner with exact specifications and sample parts or devices. Many projects run into trouble when specifications are sent to a packaging outsourcer before the product’s design has been finalised. “The supplier needs to know specific requirements for packaging including how the product will be transported and secured with the packaging, sterility issues and marketing aspects such as look and feel,” says Ronny Debaere, Group Marketing Manager, Vitalo Packaging (Meulebeke, Belgium).

Don’t Neglect Sterilisation Issues

If required, sterilisation greatly influences the packaging process. “The packaging of a product has to meet certain requirements,” says Kaczorowski. “The product must be sterilisable in the specified package, and sterility must be assured for a defined period.”

Another important aspect when it comes to sterilisation is the packaging procedure. “The process by which the sterile barrier is produced must be safe,” Kaczorowski advises. “Even in an aged and sterilised condition, the materials providing the sterile barrier must maintain sterility up to the expiration date.” The supplier also should be able to assess how transportation will affect the packaging and he should assume responsibility for the sterility of the products and keep revalidation cycles in view, he adds. Thus, the OEM can benefit by placing responsibility for an extremely sensitive process on his supplier.

Remember the Incidentals

Consider how your packaged product will be shipped, stacked and stored. If not addressed at the onset of the packaging process, you could end up with individually packaged products that are cumbersome to shelve or that do not fit into a shipping carton cost-effectively. If you are assembling in-house, look for materials suited to the particular requirements of manual or automated packaging. When selecting materials, says Debaere, packing and unpacking of the product are other issues to consider. “Important areas that change how you will handle in-house packaging include fixation of the component in the package as well as stacking of the package,” Debaere explains. “The more compact and easy the package is to stack, the less expensive storage and shipping are for the end user.”