AS 5014:2010 pdf free download – Child-resistant packaging— Requirements and testing proceduresfor non-reclosable packages for pharmaceutical products

AS 5014:2010 pdf free download – Child-resistant packaging— Requirements and testing proceduresfor non-reclosable packages for pharmaceutical products.
AS 5014 specifies performance requirements and methods of test for non-reclosabla packaging that have been designated child-resistant. This standard is Intended for type approval only (see 3.5) and is not intended for quality assurance purposes.
2 NormatIve references
This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropnale places in the text, and the piibcatlons are listed hereafter, For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (Including amendments).
EN 862:2001 Packagmg – CtWk%-i’esrsrant packagrig – Requirements and testing pi’oce*wes to, noo-reclosabfe packages for non-phamiaceutaI products.
3 Terms and definitions
For the p,i pi s of this Ewcpoan Standard, the terms and definitions given In EN 862:2001 and the following apply.
3.1
child-resistant package
package which is difficult for young children to open (or gain access to the contents), bul whioh it is possb4e for adults to use properly
3.2
non-reclosable child-resistant package
child-resistant package or part of a child-resistant package which, when aM or part of the contents have been removed, cannot be properly closed again
3.3
substitute product
inert substitute resembling the product it replaces, i.e. powder, tablets or liquids (uncoloured water), etc.
NOTE This is sometimes referred to as a placebo produci
3.4
unit dose
discrete quantity of any product to be removed from its Immediate packaging in its entirety
3.5
type approval
procedure to certify as child-resistant a specific type of nori-reclosable package, lormed from a specified set of materials, which has met the requirements of this standard
4 RequIrements
4.1 General requirements
A non.recloeable child-resistant package, when tested in accordance with the requirements of this standard, shall be capable of providing a satisfactory degree of resistance to opening by children (see 4.2.1) and a satisfactory
level of accessdity to its contents by adults (see 4.2.2),
5.3.3.2 Test procedure
NOTE 1 There is no need for the adults to be tested at any particular place or time. The test should be carried out by one person at a time and only the supervisor should be present.
Each adult shall be given a package, together with any associated opening tools that would be provided with the package at pornt of sale, and written instructions on how to open the package correctly, if any.
NOTE 2 These can be printed in or on the package when supplied to a consumer.
Each adult shall perform the test individually. No demonstration of how to open the package shall be given by the supervisor. A period of 5 mm shall be allowed for the test participants to familiarize themselves with the package to be tested by reading the opening instructions and then attempting to open it correctly. Test participants shall not be allowed to consult either the supervisor or other participants in the test.
Participants who successfully open the test package within the 5 mm period shall be given a new identical package and shall be requested to open this one as quickly as possible. A 1 mm test period shall be allowed for the participants to open the new packaging.
If in this period of 5 mm a panellist is unable to open the package being tested they will be given a screening test. This screening test consists of asking the panellist to open and reclose the following two conventional non-child resistant closures in one minute each:
a) a 28 mm diameter continuous screw thread closure applied at 1,1 Nm torque onto a 25 ml to 50 ml cylindrical plastic container;
b) a 28 mm diameter “push-oW’ closure applied to a 25 ml to 50 ml round plastic container.
Panellists unable to open and reclose both of these packages in the 1 mm screening test are to be discounted from the adult panel results.
Panellists who are able to open and reclose both these packages are counted as a failure in the overall result.
5.4 Evaluation
5.4.1 Child test
5.4.1.1 General
The result of each test shall be recorded on the test charts given in Figures B.1 and B.2 in accordance with 5.4.1.2. The results shall be evaluated in accordance with 5,4.1.3.
NOTE The statistical parameters governing the sampling procedures for the test charts are given in annex C.
The test shall be considered a failure in relation to unit, strip or blister packages if within 10 mm the child accesses more than eight unit doses from the packaging provided.