Gerresheimer presented its Duma Standard CR (child-resistant) container with Handy Cap CR at Pharmapack last month in Paris. This is the company’s first snap-on cap with child-resistant (CR) solution. The snap-on cap is a one-component-system compared to more conventional child-resistant screw-cap solutions that are made of two components.
“I’m a father myself and I know how curious children are,” says Niels Düring, Global Executive Vice President Plastic Packaging. “You have to be very careful because they’ll play with anything they can get their little hands on. So it’s vital for drugs to be supplied in childproof packaging.”
Only the 40 ml version of the new Duma Standard CR container is cur-rently available with the Handy Cap CR. Other sizes can be supplied upon request.
Children experiment with everything and that includes medicines – mummy’s tablets could well be some sort of tasty treat, after all. This means tablets should be stored out of the reach of children. This is much easier said than done, however. It is all too easy to leave a box of tablets behind on the kitchen table where your child can play with it.
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 incor-porate 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 chem-ical 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 youngchildren 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 func-tion. 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 sequen-tial 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.