Standardization News

A proposed ASTM standard aims to protect children from accidentally ingesting liquids from containers such as medicine bottles through the use of restricted delivery systems. Each year approximately 60,000 emergency department visits are made after young children find and ingest medicines while their parents/caregivers aren't looking.

Restricted delivery systems are designed to limit access by young children, even if the primary child-resistant closure is note engaged (that is, a parent does not put a child-resistant cap back on properly). For liquid products, these systems typically include a component, such as a flow restrictor, added to the bottle neck to restrict the release of product.

The standard (WK41534, Test Method for Assessing Restricted Delivery Systems for Liquid Consumer Products) will outline procedures for three types of mechanical tests on restricted delivery systems. These tests simulate shaking, squeezing and drinking (sucking) from a bottle-actions that a young child might take to access contents.

ASTM member Daniel Budnitz, director of the Medication Safety Program of the Centers for Disease Control and Prevention, says that the specific test parameters in the standard are based on existing scientific literature and are intended to represent the average abilities of children up to age five. These tests would represent worst-case scenarios, since about three-quarters of hospital emergency department visits for accidental medication exposures involve children two years old or younger.

The task group developing the standard is planning an interlaboratory study to establish repeatability and reproducibility of the test method. The group seeks labs with design, manufacturing and end-user perspectives to provide test materials and/or to participate in the study. They aim to test at least three different designs of restricted delivery systems and to have six labs conduct testing with provided samples. All interested parties are encouraged to contact Subcommittee D10.32 on Consumer, Pharmaceutical, Medical and Child Resistant Packaging.

Mark Plezia, an ASTM member is the director of Research and Development for Pharmaceutical Packaging Technologies at McNeil Consumer Healthcare. Plezia notes that package development engineers will use the standard to quantify the efficacy of flow restrictors when used in conjunction with a specific container and liquid product (that is, the full restricted delivery system). Data from testing can be used to determine if the properties of a particular restricted delivery system are appropriate for the intended use based on a product's attributes and risk profile.

CONTACT Technical Information: Daniel Budnitz, M.D., Centers for Disease Control and Prevention • Atlanta, Ga. • tel +1.404.639.4096 | ASTM Staff: Diane Lake • tel +1.610.832.9661 | Upcoming Meeting: October 25-28 • October Committee Week • Tampa, Fla.