AS 5014 pdf download – Child-resistant packaging— Requirements and testing procedures for non-reclosable packages for pharmaceutical products (EN 14375:2003, MOD)
A non-reclosable child-resistant package, in addition to conforming to the performance requirements specified in this standard (see 4.2), shall be appropriate for the contents, provide mechanical protection and function properly for the life of the content and packaging. Manufacturers, component manufacturers, fillers and packers of such packages shall initiate and operate procedures to control the quality of packaging materials so that type approved packaging is in accordance with the requirements of this standard. NOTE EN ISO 9001 specifies requirements for quality management systems where organizations need to demonstrate their capability of supplying conforming products to customers.
4.2 Performance requirements
4.2.1 Child test An individual child test shall be considered a failure in relation to unit, strip or blister packages if within 1 0 min the child accesses more than 8 unit doses from the packaging provided. When tested in accordance with 5.3.2 and evaluated in accordance with 22.214.171.124, the packaging shall be deemed to be child-resistant. NOTE The figure of eight units is based on existing national standards published by certain CEN members and does not address the issue of toxicity. Some pharmaceutical products on the market can cause harm to children by the ingestion of fewer than eight units. However, reliable data on child toxicity exists for few pharmaceutical products.
A harmful dose can be established for some existing pharmaceutical products and a maximum safe dose can be established for all pharmaceutical products by one means or another. Such information is not currently available for all products and there is no central register where this information could be held. In the absence of European legislation on this topic the drafters of this European Standard acknowledge these concerns and believe that research and collection of data should continue with a view to considering the substitution of a toxicity based pass/fail criterion for the child panel test in a later revision.
4.2.2 Adult test When tested in accordance with 126.96.36.199, at least 90 % of the adults shall be able to access at least 1 unit dose within the 1 min test period, without a demonstration . NOTE To minimise the exposure of children to unnecessary testing the adult test should be carried out before the child test.
5.1 Principle Type approval for non-reclosable child-resistant packaging is obtained by a sequential test method or full panel test for children and a full panel test for adults. A test group of up to 200 children aged 42 to 51 months is divided into pairs. Each child is given a number of non-reclosable packages to be opened by whatever means they wish to use. If a child fails to gain access within 5 min, the method of opening is demonstrated by the supervisor and the child is given a further 5 min to open the package. The results are recorded sequentially, as obtained. The package is deemed child-resistant if the trail of results on the test charts passes into the acceptance zone or if at least 80 % of the children are unable to access more than eight unit doses within 10 min and at least 85 % of the children are unable to access more than eight unit doses within the first 5 min. The package’s accessibility by a test group of 100 adults is also assessed. Each adult is given a non-reclosable package, any associated opening tools and written instructions, and is allowed 5 min to familiarize themselves with the packaging. The number of adults opening the package within a 1 min test period is recorded. The package is deemed to comply with the requirements of this standard if at least 90 % of the adults are able to access at least 1 unit dose in 1 min.