It is Child’s Safety Week from June 7 – June 13 2021 and we would like to raise awareness for this very important topic as well. This year’s slogan of the event “Share because you care” is why we would like to share our knowledge with you.
The main causes of poisoning accidents for young children are medicines. When misused, medicines generally pose a risk to children of all ages but this risk is particularly high for young children under the age of four. They do not yet have the knowledge of the hazardous nature of certain packages contents plus tend to put many things in their mouths uncontrollably.
It is therefore essential to take child safety into account in the area of packaging development. So-called child-resistant packaging (CRP) is designed to prevent children from coming into contact with hazardous contents and lower the events of accidental poisoning by means of special closure mechanisms.
There are many different ways to make a packaging child-resistant. Reclosable packaging with closures that work on the principle of "press and turn" are the best known of these. Many reclosable child-resistant packages rely on an opening principle in which two movements must be coordinated simultaneously. Other non-reclosable packaging achieves safety by using materials that are difficult to open or by performing several opening steps in succession (e.g. peel-push blisters). Some examples are shown below.
Various international standards exist to verify and ensure the proper functioning of child-resistant packaging. The USA were a pioneer in this field introducing the Poison Prevention Packaging Act (PPPA) more than 50 years ago. It was the world's first regulation to address the issue of CRP of potentially hazardous substances. For the rest of the world the requirements placed on CRP for pharmaceutical products can be found in the standards DIN EN ISO 8317 and DIN EN 14375. Whereas DIN EN ISO 8317 is the international standard for reclosable packaging, DIN EN 14375 includes the requirements for non-reclosable pharmaceutical packaging.
In order for a pharmaceutical product package to be considered child-resistant it must meet one of the standards mentioned above. All of them require a test not only for child safety but senior citizen friendliness as well, as the design of the CRP must fulfill the two following requirements:
→ Opening of the package must be significantly difficult for children under the age of 5
→ Opening of the package shall not be difficult for an average adult (especially elderly people)
The child safety part is performed with at least 50 children (and maximum 200 children) aged 42-51 months. During the test the children are asked to open the package for five minutes. If they don't succeed they are shown how to do it and given another 5 minutes to open the package. The package is considered child-resistant if at least 85 percent of children were unable to open the package in the first five minutes before the demonstration and at least 80 percent of children were unable to open the package after the demonstration.
Although CRP is an important step it should be noted that “child-resistant” is not equal to “child-proof”. The design of the CRP can make access to harmful products more difficult but cannot prevent the possibility of accidental pediatric ingestion. Therefore please make sure to store all drugs out of sight and reach of children in order to keep them safe.
DIN EN ISO 8317:2016 Child-resistant packaging - Requirements and testing procedures for reclosable packages
DIN EN 14375:2018 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
Unique Device Identification (UDI) systems are arising worldwide, and understanding similarities and differences between them is key to be able to meet the requirements for each specific country or region.