AS 5014:2010 – Child-resistant packaging— Requirements and testing proceduresfor non-reclosable packages for pharmaceutical products (EN 14375:2003, MOD)
AS 5014:2010 – Child-resistant packaging— Requirements and testing proceduresfor 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, prowde mechanical protection and function properly for the life of the content and packaging.
Manufacturers, component manufacturers, fillers and packers o4 such packages shall initiate and operate procedures to control the quality of packaging materials so that type approved packang is in accordance with the requirements of this standard
NOTE EN ISO 9001 speolles reqisrements for quality management systems Mere organizations need to demonstrate their capability of supplying coromwig products to customers.
4.2 Performance requirements
4.2.1 Child test
An individual child test shall be considered a fadure in relation to unit, strip or blister packages if within 10 mm the chdd accesses more than 8 unit doses from the packaging provided.
When tested in accordance with 5.3.2 and evakiated in accordance with 126.96.36.199, the packaging shell be deemed to be child-resistant,
NOTE The figure of eight units Is based on exishng nabonal standards pIIshed by certain CEN members and does not address the issue of toxicity. Some pharmaceutical products on the market can cauae harm to children by the Ingestion of fewer than eight units. However, reliable data on child toxicity exists tor few pharmaceutical products A harmful dose can be established for some existing pharmaceutical products and a manum safe dose can be established for all pharmaceutical products by one means or another. Such information Is not currently avadable for aS products and there is no central register where this Information could be held. In the absence of European legislalion on mis topic the draflers 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 cntenon for the child panel test in a later revision.
4.2.2 Adult test
When tested in accordance with 188.8.131.52. at least 90 % of the adults shall be able to access at least I unit dose within the I mm test peflod, without a dennonstraiton,
NOTE To minenise the exposure of ctiidren to isinecessary testing the adult test should be cenfled out before the child test
Type approval for non-redosable 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 mm, the method of opening is demonstrated by the supervisor and the child is given a further 5 miii 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 unabfe to access more than eight unit doses within 10 miii and at least 85 % of the children are unable to access more than eight unit doses within the first 5 mm. The package’s accessibility by a test group of 100 adults is also assessed. Each adult is given a non-redosable package. any associated opening tools and whiten instructions, and is allowed 5 miii to familiarize themselves with the packaging The number of adults opening the package within a 1 mm test period is recorded. The package is deemed to comply wilti the requirements of this standard (at least 90 % of the adults are able to access at least I unit dose in 1 min.