Child-resistant Packaging: As Easy as Possible, As Difficult as Needed

Ursula Hahn
Head of Product Management
Sanner Group

Child-resistant (CR) packaging is used to minimize the risk of children accessing or ingesting medication and is one of the best-documented successes in preventing the unintentional poisoning of children. So, manufacturers & companies are utilizing the techniques of child resistant packaging for medicinal products as per the established norms & standards of the country.

A good plastic packaging solution for pharmaceutical and healthcare products must fulfil many requirements. It should protect the product from exterior influences and inform users about the content, while conveying marketing messages and boosting sales. At the same time, it must make sure that the content is easy to remove and that the package can be re-closed and re-opened effortlessly. Another highly important prerequisite is child safety. Every package should be designed in a way to protect children from unintentional ingestion of medication. Regulatory bodies have issued guidelines, and industry is already undertaking measures to conform to regulations and make their packaging solutions safer for children.

Packaging as Safety Hazard

Children often show unexpected skills when they want to access the content of pharmaceutical packaging. One the one hand, some exterior package designs suggest they might contain sweets of some sort. On the other hand, many tablets and pills actually do taste rather sweet due to their sugar coating. However, this infantile drive and curiosity can have dramatic consequences. Toddlers are especially vulnerable, as they discover their environment through touching, sucking and chewing. Children between just below one year and approximately four and a half years of age tend to put objects in their mouths or even swallow them.

Child-resistant packaging, also known as CR packaging, can help prevent unintended child poisoning. To open such a package, for instance a plastic tube or other container, you need to know a certain “trick”. This trick is often too difficult for infants to learn. For example, a three year-old will most likely not find out how to open a package that requires the closure to be tipped while it is pushed open simultaneously. At the same time, access to medication must still be granted for patients depending on their regular dose. For this reason, CR packaging should always also be senior-friendly in terms of opening and handling – according to the motto "as easy as possible, as difficult as needed".

LDiffering Regulations

CR packaging is already subject to national and international regulations, however not on a uniform basis. This is especially true for pharmaceutical products. Here, the U.S. takes a leading role. As far back as 1970, the “Poison Prevention Packaging Act“ (PPPA) took on this topic due to the rising number of poisoning through toxic chemicals used in households. The regulation US 16 CFR § 1700.20 defines consistent rules for dangerous chemical-technical and pharmaceutical products. Apart from few exceptions, all prescription drugs must be packaged in a child-resistant manner. Moreover, the regulation determines which requirements are valid for CR packaging and which tests need to be carried out.

The Indian standard determined in 1995 defines CR packaging as “any packaging which is difficult for young children under the age of five to open (or gain access to the contents), but which is not difficult for adults”. Here, too, the philosophy “as easy as possible, as difficult as needed” is applied. The aim of this standard is to “form a practical basis for the development of packages with acceptable child-resistant features and to offer an advice to manufacturers when selecting unit dose packaging with a view to child safety”.

Small Modification, Large Effect

There is no mistaking that CR packaging can save lives. This is why many drug producers are not waiting for continent-wide or even worldwide regulations. Instead, they have already begun to look for suitable packaging solutions years ago. So what is most important when choosing the ideal plastic packaging? It should be cost-efficient, user-friendly and child-resistant. To fulfil all three criteria, pharmaceutical and healthcare companies are well-advised to cooperate with a supplier who is experienced in packaging engineering and can optimise a packaging concept in line with regulatory requirements with only a small modification.

Manufacturers of primary plastic packaging with long-term market experience have clear processes installed, including efficient project management and reliable quality management. During product development, a stage-gate process with regular re-tests makes sure that the packages fulfil all requirements. Documentation and reproducibility of the CR features are just as important. If a partner meets these prerequisites, the specific CR solution can be chosen.

Combination of Strength and Cognitive Component

Two aspects should be taken into account – purely "mechanic", that is force-related safety, as well as the cognitive component. On the one hand, a learning effect is required, for instance when a closure can only be opened through a certain sequence of movements. On the other hand, the force needed to open a package is just as important. Apart from the push/turn version commonly used for large tablet containers in North America, there are numerous further possibilities to make primary plastic packaging child-resistant through a combination of movements. When pushing and tipping, for instance, not much strength is required. This, in turn, makes the packaging suitable for grown-up users, especially senior citizens.

The motto "as easy as possible, as difficult as needed" brings it to the point: two pressure points, which are incorporated into the closure, enable grown-ups to easily open this self-explanatory packaging. Children, however, find it difficult, especially due to the fact that the push movement is followed by a tipping movement. A clear upper and lower limit for the applicable force should be defined at an early development stage. This way, relatively simple changes to a packaging such as the aforementioned pressure points can ensure additional safety. In the past years, a number of respective plastic packaging solutions have been developed and introduced to the market. They not only show how important child-resistant packaging is. They also prove that safety and user-friendliness can be combined without much effort.