Child proof or child resistant means packaging designed to protect the contents from external agents and prevent children from opening it. In the pharmaceutical field, child proof packaging is specifically designed to prevent children from accessing and ingesting medications in a domestic setting. In addition to the product communication and conservation, pharmaceutical packaging, it is crucial that packaging protects children from potentially harmful formulations that could endanger their health. Regulations in this area clearly define the tests and requirements for child-resistant packaging, wich must present more than one obstacle to any attempt to open it. New designs have been adopted over time to balance child safety with accessibility for adults.

Regulatory framework

Child proof packaging is regulated by UNI standards, which set specific standards for package closures. UNI EN ISO 8317:2016, “Child-resistant packaging – Requirements and test methods for reclosable packaging” specifies performance requirements and test methods for reclosable packaging designed to be resistant to opening by children. UNI EN 14375:2016, “Child-resistant non-reclosable packaging for pharmaceutical products – Requirements and testing” applies to child proof non-reclosable packaging for pharmaceutical products, including unit dose packaging and blister packs.

UNI EN ISO 13127:2012 provides strict regulations for conducting mechanical resistance tests to ensure that packaging is child-resistant. This document supports packaging design and production by providing packaging companies with data to compare and verify the validity of child proof closure system characteristics.

Finally, UNI CEN/TR 16353:2013, “Packaging – Safety guidelines for flexible plastic packaging to minimize the risk of choking by children”, focuses on both disposable and reusable flexible plastic packaging, which can pose a serious choking hazard to children when used in the home environment.

Functions of child proof packaging

As required by regulations, child proof packaging must have mechanisms (such as clicks, rotations, etc.) that are complex enough to prevent children under the age of 5 from opening it, but easy enough for adults over 70 to open if necessary. There are different types of child-resistant closures depending on the packaging material, but all packaging must include durable elements that can withstand all opening attempts. Child-resistant closures must not neglect the primary function of protecting medication from external agents such as moisture, oxygen, and light.

Compliance tests should be conducted in the presence of children (aged between 42 and 51 months) and adults. Children have 10 minutes to open the packaging. If they fail, they will receive a demonstration on how to open it, followed by another 5 minutes to try again. The packaging is considered compliant if at least 85% of children are unable to open it within the first 5 minutes of the initial test, and at least 80% are unable to open it within 5 minutes of the demonstration.

As is evident, the child proof standard does not aim for complete impenetrability of the packaging. Instead, it focuses on the time it takes for a child to partially open the package by forcing the closure mechanisms. It is important to note that child-resistant closures cannot be entirely impossible for small children to open, as they may present significant accessibility issues for adults, especially in the case of patients with disabilities and motor limitations.

For this reason, compliance tests are also conducted on adults aged between 50 and 70 years, selected according to specific parameters. The test consists of two phases: in the first phase, participants have 5 minutes to open the packaging. If successful, they proceed to the second phase, where they are given another package and have only one minute to close it. The packaging is considered compliant if at least 90% of adults, even with opening instructions, can open it within the first five minutes of the first phase and within one minute in the subsequent test.

Child proof solutions for pharmaceutical packaging

Over time, various child-resistant packaging solutions have been developed, based on customized designs that rely on children’s still limited finger coordination abilities. One of the most common solutions involves plastic or glass bottles with a “push and twist” mechanism cap, requiring two different simultaneous movements: pushing down and twisting counterclockwise.

Regarding secondary paper and cardboard packaging, common solutions are boxes with bellows or interlocking flaps, suitable for containing heavy products such as bottles. These types of packaging often come with an opening ‘key,’ which is an external element that unlocks the interlocking mechanism. Without this key, access to the medication is not possible. Other solutions may require pressing two buttons located on the sides of the packaging at different heights simultaneously to initiate the package’s snap mechanism and open it.

Alternatively, flexible single-dose sachets or customised thermoformed containers have been designed to fit perfectly with vial dosages and can be opened or closed multiple times without losing resistance, stability, and safety.

Thanks to Eurpack, pharmaceutical packaging can be customized to comply with current regulations. The Packaging Development Center designs and develops innovative solutions according to customer needs, sharing every phase of the project.