Health & safety in pharmaceuticals

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Protecting the consumer with child resistant packaging standards

By law, pharmaceutical manufacturers must package certain medicines in child-resistant packaging. The aim of child-resistant packaging is to keep little fingers out of products that could harm them while ensuring that adults can still open and close packaging easily. The World Health Organization and UNICEF state that child-resistant packaging is one of the best-documented successes in preventing accidental poisoning of children. If pharmacies dispense prescription medicines in their original factory packaging, such as a box containing blister packs of tablets, the packs will not have been subject to standardized testing for child resistance. It’s important for consumers to be aware to take extra care when storing these medicines. A child-resistant package usually requires a special ‘trick’ to open it – something too complicated for most young children to work out. For example, users might have to push or squeeze a lid at the same time as turning it. It’s also possible to make non-resealable packs, such as blister packs, child-resistant by using very strong material or covers that must be peeled off. Several European child-resistant packaging standards have been developed to help manufacturers design packaging that is both safe and effective. Child Resistant Packaging Standards: The Basics Child-resistant packaging standards explain how to carry out objective tests of child resistance, helping designers and makers ensure that most children can’t access poisonous products. Standard BS EN ISO 13127:2012, introduces mechanical tests for checking the safety of minor changes to existing child-resistant packs, detailing for the first time how manufacturers can use machines rather than people to test the child resistance of some packaging. It describes ten mechanical tests for different types of packs, such as testing the force needed to push, pull or squeeze a bottle open. These tests are to be used only in the case of minor modifications to existing child-resistant packaging. They provide a reliable way to compare modified packs with products that have already been tested with children. And they mean consumers can be sure that any alterations to packs are as safe as the original. Standard BS EN ISO 8317:2015 explains test methods for resealable packs such as bleach or medicine bottles, whilst BS EN 14375:2018 covers non-resealable packaging for pharmaceutical products (for example blister packs of tablets) and BS EN 862:2016 covers non-resealable packaging for non-pharmaceutical products. In your compliance-critical industry, ensure you are meeting the industry safety standards. A BSI Knowledge subscription gives you instant access to the resources you need to improve the safe design, manufacture, and use of child-resistant packaging. Build your own custom collection of standards, or opt for access to over 4,800 documents in our GBM05 Sciences & Healthcare module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. To learn about managing risk in medical laboratories, click here. Child Resistant Packaging Standards: The Details The standards state that child-resistant packaging should be tested with children and adults as follows: A group of children aged between 42 and 51 months is asked to open a pack. If they don’t succeed after five minutes, they are shown how to open it, and then given five more minutes to try again. A child-resistant pack should be impossible to open for at least 85% of children in the first five minutes, and for at least 80 percent following the silent demonstration. The pack is also tested with a panel of adults aged between 50 and 70. At least 90% of this group must be able to open and reclose the pack or – for a non-resealable pack – open it and remove one item. The test uses older adults as they are most likely to have difficulty opening and reclosing child-resistant containers. Group sizes vary because a sequential testing method is used. The child test, for example, usually involves between 30 and 60 children, but testers might need to use as many as 200 children to get a clear picture of a pack’s child resistance. Ensure your pharmaceutical organization is complying with pharmaceutical safety regulations by adopting these child-resistant packaging standards today.

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