Düsseldorf/Paris, January 23, 2019. Gerresheimer will take the wraps off their first snap-on cap with child-resistant (CR) solution at booth B62 at this year’s Pharmapack, which will open its doors between February 6 and February 7 in Paris, Porte de Versailles. Conventional child-resistant screw caps are made of two components.
“Packaging drugs in a childproof manner is imperative. Small children explore their world by touching everything and putting everything in their mouths. This is why we have to stay cautious and alert to keep drugs from finding their way into children’s hands,” explains Niels Dürung, Global Executive Vice President Plastic Packaging.
Packaging like the new Duma Standard CR container with its child-resistant cap is designed to prevent young children from getting hold of items like medicines that could be harmful to their health. Many products that could pose a threat to young children’s health are required to incorporate a safety device under national and international law. ISO standard 8317 (2015) applies in Europe and US 16 CFR section 1700.20 in the U.S.
ISO 8317 (2015)
ISO 8317 (2015) is the international standard for reclosable child-resistant packaging. It governs both pharmaceutical and technical chemical products.
The standard describes two test procedures, which any packaging to be tested must be subject to. One test is run with a group of up to 200 young children aged between 42 and 51 months. They must not be able to open the packaging, which is filled with a harmless replacement substance. At the same time, a test group of older people aged between 50 and 70 must be able to open and reclose it without imparing the child-resistant function. Packaging will only meet the requirements of ISO 8317 (2015) if the tests demonstrate that they are safe for children and user-friendly for the elderly, as defined in the standard.
During the test, children have an initial five minutes to try opening the packaging. Afterwards, they are shown how to open it once without any explanation. They then have another five minutes to try opening it.
The packaging is deemed child-resistant if no more than 15 percent of children are able to open it within the first five minutes. A maximum of 20 percent of children are permitted to succeed in getting at the contents of the packaging for the entire duration of the test.
If only a few young children manage to open the packaging, the test group could be reduced to fewer than 200 children as part of the sequential evaluation process.
Tests with older people aged between 50 and 70
During the test, the participants have an initial five minutes to try opening the packaging. They are not shown how to do so besides the instruction on the packaging. In the second phase, they only have one minute to try and open it. The packaging is deemed suitable for older people as long as at least 90 percent of the test group are able to open and reclose it again without imparing the child-resistant function within a reasonable amount of time.
The test group is designed to include 100 people, of whom 25 are aged between 50 and 54, 25 between 55 and 59, and 50 between 60 and 70. 70 percent of each of these age groups should be female.
The US 16 CFR section 1700.20 regulation also stipulates the requirements child-resistant packaging must meet. These are similar to the standards applicable in Europe but are even more extensive for medicines.