AS 5014:2010 pdf – Child-resistant packaging- Requirements and testing procedures for non-reclosable packages for pharmaceutical products.
5.2 Samples and sample preparation
Sufficient packages shall be produced by the proposed manufacturing process to enable a representative sample to be selected by the supervisor for testing and to provide a reserve for reference purposes. Dangerous products shall not be used to fill the package to be tested: an appropriate substitute product shall be used. The material and desçn of the test samples shall conlorm to the technical specification and they shall be representative of an average batch of oflginal packages.
Packages tot the child panel test shall be unprinted.
In every test, a new package shall be provided for each member of the test group. For both the child and adult tests, there shall be at least 10 unit doses available for each participant
Each sample package shall be checked for integrity before the test is conducted. The packages shall be presented to the children without the outer retail packaging, giving them access to the individual unit doses.
5.3 Procedure
5.3.1 General
The test proce&re is carried out in two stages:
a) child test (see 5.3.2);
b) adult test (see 5.3.3).
5.3.2 Child test
5.3.2.1 Composition of child test group
The test group shall comprise no more than 200 children aged 42 to 51 months, inclusive, with approximately equal numbers of girls and boys. As tar as possible, there shall be an even distribution of ages and sexes within the panel. The children shall be selected at random and shall have no apparent physical or mental disability which might affect manual dexlerity They shall not have taken part in more than one previous test and, in that test, a packaging of a different type and desigi shall have been used. If a child is used for more than one test there shall be at least 4 weeks between tests. Parental or guardian consent shall be obtained before the child is used as a part of the test group. Any children having been involved in a reported poisoning accident shall be excluded from the test.
NOTE Children should be selected to represent as dosely, as Is reasonably possible, the different social, ethnic end cultural orlans or the pq)ulation as a whole, arid not lust of the Immedate distnct in which the test Is carned 014.
5.3.2.2 Tnt procedure
Testing shall be carried out in the presence of a test supervisor. The child test shall take place in an environment familiar to the children.
NOTE 1 Test personnel should visit tie test location beforehand and bane known by the children In order 10 901 their contidence Only the supervisors should be present, parents being excluded from the test
The test shall be carried out by a sequential procedure (see 5.4.1.1 to 5.4.1.3). The number of children tested will therefore depend on the results obtained, however, the age and sex constraints specified In 5.3.2.1 shall be
adhered to.
Pairs of children shall be involved in the test, each pair being monitored by one supervisor. Should a child wander off during the test, action by the supervisor shall be limited to leading the child back to its place and requesting that he or she continue the test, without any additional instruction being given concerning the opening of the package.
AS 5014:2010 pdf – Child-resistant packaging- Requirements and testing procedures for non-reclosable packages for pharmaceutical products
