When it comes to blister packaging materials for pharmaceuticals and food, error can cause harm to the end-user. That’s why manufacturers are required to adhere to FDA blister packaging compliance standards.
In this blog, we’ll cover the following topics regarding compliance for blister packaging:
- How Blister Packs Are Made
- Types of Products for Blister Packaging
- Compliance Requirements for Blister Packaging
- Compliance Packaging Children’s Test
- Compliance Packaging Adult’s Test
How Blister Packs Are Made
Blister packs are made using special machines that utilize heat and pressure to form the plastic into a desired shape. They can produce various shapes, sizes, thicknesses, and colors, depending on your needs. The packaging process includes creating an air-tight seal around each tablet or capsule to ensure that the product is kept safe until it reaches the end user. Once the packaging is manufactured, the machine fills the blister pack with product before it’s sealed with a backing material, such as aluminum foil or paperboard.
Blister packaging machines typically use a three-step process:
- Forming: A forming mold is used in either the thermoforming or cold forming process to create a tray with cavities or pockets that match your exact product requirements.
- Sealing: Your product is placed inside the cavities. The trays are sealed with pre-cut pieces of your choice of lidding material using knurled or flat heat-sealing plates.
- Perforating and Cutting: The sealed trays are cut and perforated using a precision die cutter. Consider adding perforated brake lines between your blister packs’ pockets before the final perimeter cut.
Types of Products for Blister Packaging
Besides pharmaceuticals, there are many other types of products packaged in blisters, like:
Typically, blister packs are used for solid unit doses of medicines and keep tablets or capsules separate and protected until used.
Compliance Requirements for Blister Packaging
The FDA packaging compliance requirements state that a controlled substance that has any preparation for human use that consists in whole or in part of any substance subject to control under the Comprehensive Drug Abuse Prevention and Control Act of 1970 and that is in dosage form intended for oral administration shall be packaged in accordance with the poison prevention packaging standards.
The compliance blister packs must continue to function with the defined effectiveness specifications when coming in contact with the contained substance. To satisfy this requirement, appropriate scientific evaluations must be conducted to assess the compatibility of the substance with compliance packaging. Our team of engineers can help create package designs implementing the best senior-friendly, child-resistant features based on your specific application.
Basic Blister Packaging Requirements
All over-the-counter products must have a Drug Facts label that includes important information such as active ingredients, purpose, uses, warnings, dosage instructions, and inactive ingredients. This information must be printed clearly and legibly on the packaging. Most blister packs also need to have tamper evidence to show if the product has been opened.
Compliance Packaging Children’s Test
One to four groups of 50 children are randomly selected for compliance packaging testing. Overall, 30% of the children are 42-44 months old, 40% are 45-48 months old, and 30% are 49-51 months old.
Any tamper-resistant feature of the compliance packaging tested shall be removed before testing unless it’s part of the package’s CR design. In the children’s test, the outer packaging is not given to the child to ensure the compliance blister packs are the only packing tested for compliance.
The FDA packaging compliance children’s test aims to ensure that no child opens the compliance blister packs successfully. However, compliance packaging can still pass the test even if a child manages to open it, depending on the number of children included in the test. For example, if 50 children are given the packaging and a maximum of three children open it within the first five minutes, the test is considered passing. If four to 10 children open the packaging within the first five minutes, a sequential test is performed at a later date. If more than 11 children opened it, the packaging failed to meet the compliance requirements.
Compliance Packaging Adult’s Test
The compliance packaging requirements for adult testing are vastly different from the children’s test. That’s because the goal is not the same; tablet manufacturers are required to design compliance blister packs that are easily accessible to adults but difficult for children.
The adult test involves 100 senior adults who are a mix of males and females and selected at random. In this case, 25% of the participants are 50-54 years old, 25% are 55-59%, and 50% are 60-70 years old.
Participants who cannot open the packaging within the first five minutes are given a screening test, which uses two packages that are not CR compliant. These adults are considered ineligible if they cannot open the non-CR packaging within one minute. However, if most of the eligible adults open the package within the first five minutes of the test period, the compliance packaging passes.
Choose Ascend as Your Compliance Blister Pack Expert
We know that compliance packaging testing is a daunting process. When you partner with us for your full-service compliance packaging needs, we bridge the gap between you and testing facilities, allowing you to focus on running your business. We communicate with material vendors and testing facilities to ensure they have everything they need to perform a successful FDA packaging compliance test.
It’s crucial to design packages that meet leak detection and CR packaging requirements. With Ascend, you find the right machine and tooling balance, allowing adults to quickly open the packaging and preventing children from accessing the controlled substance inside. Contact us today to learn more about how we can help you with compliance packaging.
