Standardization News

Each year thousands of children are brought to hospital emergency rooms after ingesting medicine they've gained access to on their own. The PROTECT Initiative, led by the Centers for Disease Control and Prevention, brings together public and private partners to help keep children safe from unintentional medication overdoses.

A key activity of PROTECT has been to encourage development and evaluation of enhanced safety packaging. These efforts have led to the development of a proposed new ASTM standard for flow control devices for liquid medicines and other consumer products that may be hazardous to children.

The proposed new standard, ASTM WK41534, Practice for Assessment of Non-Metered Flow Control Devices for Liquid Consumer Products, is under the jurisdiction of Subcommittee D10.32 on Consumer, Pharmaceutical, Medical and Child Resistant Packaging, part of ASTM International Committee D10 on Packaging.

Flow control devices are adapters added to the neck of a bottle to control the release of liquid and could be used as a means to limit the amount a young child could access if an initial child-resistant closure, such as a bottle-and-cap system, is breached. These devices have the potential to be an important safety innovation for liquid medicines.

However, while different flow control devices are currently available, there are no standards for the operating characteristics of such devices. The proposed ASTM standard will help manufacturers to assess whether specific flow control devices would be effective in limiting child access when used in combination with specific liquid contents.

The proposed practice will cover the assessment of non-metered flow control device characteristics so that the devices can be evaluated to standards that represent efficacy in limiting accessibility of liquid medicines to young children. ASTM WK41534 will use mechanical testing to simulate methods that could be used by young children to access liquid products.

Types of mechanical tests to be covered in WK41534 include:

The proposed practice will cover field conditions and variables such as temperature, fill capacity, angle of inclination and applied pressure/force. For each condition tested, the amount of liquid removed will be assessed.

The D10.32 task group developing WK41534 welcomes all interested parties.

CONTACT Technical Information: Dan Budnitz, Centers for Disease Control • Atlanta, Ga. • Phone: 404-639-4096 • Stuart Dejong, Primary Delivery Systems • Deland, Fla. • Phone: 386-228-1004 | ASTM Staff: Diane Trinsey • Phone: 610-832-9661 | Upcoming Meeting: Aug. 20, 2013, 2:00 p.m. Contact Diane Trinsey, ASTM International, for more information.