The end consumer, and in many cases the manufacturer, pay great attention to what’s printed on the blister pack. But manufacturers also need to work closely with blister pack printing adhesive partners to ensure that FDA-compliant packaging materials are used for all components, including adhesives, printing ink, and substrates.
The U.S. Food and Drug Administration (FDA) is tasked with guaranteeing that products are safe for human consumption. FDA guidelines for pharmaceutical and food packaging apply to materials used for both protection and storage.
Examples of areas where consumer safety might be at risk include:
In food packaging, the FDA closely regulates the safety of all plastics that come into contact with the food itself. A list of these approved substances can be found in the FDA’s database.
Printers also need to be in compliance with specific FDA guidelines for pharmaceutical blister packaging materials. They may need to provide an MSDS (Material Safety Data Sheet), which details ingredients for categories such as:
For medications, the FDA’s industry guidance on regulatory requirements in pharmaceutical packaging include:
With blister packs, attention lands specifically on their ability to provide evidence of tampering and promote the integrity of the protected medication.
Take the safety of all materials into consideration, including the use of FDA-compliant packaging, FDA-compliant adhesives, and FDA-compliant printing ink.
Although most of the responsibility falls on the product manufacturer’s side, it’s crucial to align with a printer that shares the same goals.
The producer should alert the printer when it needs to use FDA-compliant materials. Work only with printers that use materials and processes with the specific intent of being compliant. If the blister pack pri
A printer may need to request letters from all vendors in the production line attesting that their materials, processes, and adhesives are indeed FDA compliant. Allow sufficient time in the production process to get these assurances. When you’re introducing new products that must be FDA compliant, account for longer testing time.
While inks and adhesives are crucial in FDA-compliant blister pack printing, the printer also needs to verify that the image carriers are following regulations.
There are FDA-compliant image carriers, including latex-free options, available that can transfer ink and adhesive. For more information about regulatory issues and other blister packaging problems, contact a flexographic printing expert.
(Editors Note: This blog was originally produced in 2020 and was updated recently to reflect new and current information)