Regulatory Focus™ > News Articles > New Standard Aimed at Strengthening Child-Proofing Systems

New Standard Aimed at Strengthening Child-Proofing Systems

Posted 20 December 2012 | By Alexander Gaffney, RAC 

A new mechanical testing standard is aimed at providing manufacturers of child-proof containers with new methods to test their products to ensure that they, and in particular pharmaceutical products, are secure over time.

The standard, ISO 13127:2012: Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems, was released by the International Organization for Standardization (ISO), a standards-setting organization often relied upon by global regulatory agencies, on 19 December 2012.

Why Child-Proofing?

Under normal circumstances, clear labeling about the potential toxicities of a product are sufficient to keep most adults from accidentally ingesting a product. Young children, however, are often illiterate or otherwise lack the worldly knowledge or impulse control necessary to keep themselves safe if they encounter an unsecured bottle of pills, which often look similar to candy.

ISO notes that under such circumstances, a "physical barrier between the child and the hazardous product" is often the preferable approach. Though far from a panacea of protection, "The packaging functions as a last defense if other barriers separating children and hazardous products have failed," the standard notes.

"ISO 13127 will make it easier for manufacturers and brand owners to ensure that packs, for either regulated products, or those where corporate social responsibility demands extra protection and to ensure that consumers are given that protection," wrote Stephen Wilkins, chair of the ISO technical committee that worked on the standard. "It is a standard to aid development."

Mechanical Testing

At the root of validating child-proof packaging is mechanical testing, which must take into account a number of factors inherent in the container: its dimensions, material composition, shape, rigidity, any sealing features, its thread, the child-resistant system used and any external handles.

A number of tests are available to test the mechanical properties of any child-proofing system, ISO notes. Many of the tests-torque test, squeeze test, engagement test, push and turn test, etc.-are intended to show the amount of force necessary to open a container. Others, such as the reverse ratchet torque test and the disassembly test, are done to make sure a product is not able to be forced open by a child. ISO notes that a minimum of ten samples should be used during each test.

The standard is meant to act in conjunction with ISO 8317:2003, Child-resistant packaging-Requirements and testing procedures for reclosable packages, and will not replace the panel testing required by that standard, ISO notes.


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