There is a wide range of child-resistant packaging requirements to meet before your product can make it to market. Find out more about packaging features that make it difficult for children to open, but easy for adults to access.
- Compliance packaging must not interfere with the effectiveness of the substance contained inside.
- Extensive testing ensures that the child-resistant packaging is equipped with appropriate features.
- Many products outlined by the Consumer Product Safety Commission (CPSC) require child-safe packaging.
- There are several types of child-resistant packaging options available, such as child-resistant blister packaging and bottles with child-resistant caps.
The Food and Drug Administration (FDA) regulates tablet packaging for pharmaceutical products. There are several significant regulatory requirements in pharmaceutical packaging that tablet manufacturers must adhere to for packaging approval:
- The compliance packaging must not interfere with the effectiveness of the substance contained inside.
- This drug packaging requirement can be satisfied by properly evaluating the compatibility of the substance with the special packaging.
- The package design must also support the number of openings and closings customary for its size and contents for packaging approval.
- This compliance pack requirement can be satisfied by testing the packaging’s physical wear and stress factors and the force required for activation.
- Tablet packaging is approved if, for the duration of regular use, the effectiveness of the packaging’s opening and closing method remains in quality condition.
Child-resistant (CR) packaging aims to reduce the risk of children consuming hazardous products. Compliant pharmaceutical packaging balances seamless accessibility and difficulty, making it difficult for children to access the products inside and easy for adults to open the packaging.
Ascend specializes in customizing blister tooling change parts to develop high-quality CR packaging.
Extensive testing ensures that the compliance packaging is equipped with appropriate child-resistant features that decrease the risk of children ingesting unsafe, controlled substances.
The U.S. Poison Prevention Act of 1970 defines child-resistant packaging as “significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable period but not difficult for normal adults to use properly.”
The FDA conducts testing by randomly selecting one to four groups of 50 children, including 30% aged 42 to 44 months, 40% aged 45 to 48 months, and 30% aged 49 to 51 months. Before the test, tamper-resistant packaging features are removed unless they’re part of the package’s design.
The child-resistant packaging test ensures that no child opens the packaging successfully. However, a package can still pass as child-resistant even if a child manages to open it, depending on the number of children included in the test. For example, if 50 children are included in the test, and a maximum of three children open the packaging within the first five minutes, the packaging is considered passing. If four to 10 children open the packaging within the first five minutes, another test is performed at a later date. If more than 11 children open the packaging successfully, it fails to meet child-resistant packaging requirements.
Many products outlined by the Consumer Product Safety Commission (CPSC) require child-safe packaging.
Pharmaceuticals that contain the following ingredients require child-resistant packaging:
- Elemental iron
There are a variety of other pharmaceutical products that require CR packaging, including any OTC drug that requires a prescription to access.
Certain nutraceuticals like vitamins and dietary supplements require child-resistant packaging. For example, products that contain iron must have CR packaging because it’s toxic for children in high doses.
Cannabis is still illegal federally, so packaging it is challenging and requires specific regulatory requirements.
Medical and recreational cannabis packaging requirements are determined by individual states and dependent on the manufacturer’s location. For example, in Illinois, cannabis packaging must include a label warning that the product is intended for use by adults 21 and over. Cannabis packaging in Illinois must comply with current CR requirements administered by the CPSC.
There are several types of child-resistant packaging options:
- Safety caps
- Blister compliance packs
- Child-resistant aerosol cans
- Child-resistant zipper closures
Bottles have features that make them child-resistant, but typically, it’s the cap that makes them child-safe packaging. Child-resistant caps for bottles are available in several varieties, including:
- Rim snap
- Squeeze and turn
- Push and turn
- Squeeze and pull
Certain caps are designed for glass bottles, while others are made specifically for plastic. For example, push-and-turn caps are often used with plastic bottles to store and dispense medications at pharmacies, while glass syrup bottles typically use BPA-free caps.
Blister packaging is one of the most commonly used packaging types for pharmaceuticals. Child-resistant blister packaging is easy to manufacture by using multilayer backing. Manufacturers use aluminum, PVC, PVdC, PE, PP, aclar films, and cold form foils to make blister packs more challenging to open for children. However, child-resistant blister packaging that meets FDA requirements is easily accessible to adults by simply peeling the back of the packaging and pushing the tablet through the backing.
With more than 50 years of experience with tablet packaging compliance, Ascend Packaging is the leading manufacturer of innovative machines and tooling that produces quality compliance packaging for your tablets. We specialize in finding innovative ways to comply with child-resistant packaging requirements. Our machines and tooling are designed with precision in mind, protecting the product and preventing contamination.
With us as your packaging experts, you get the right machine and tooling to manufacture packaging that’s easy to open for adults but difficult for children to access. That’s why we’re the leading manufacturer of tablet packaging equipment and tooling for a wide range of industries. Contact us today to learn more about regulatory requirements in pharmaceutical packaging.