Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing for blister packs

Anja Hilse (Abschlußjahr: 2004)

In this thesis, a comparison has been made of the status of child-resistant pharmaceutical packaging, special for non-reclosable blister packs, in certain areas of the world. The historical development of the regulations in Europe, the USA and some other Non-European countries is described, compared and discussed. One of the major results of this analysis was that a considerable number of nations have meanwhile established regulations for child-resistant packaging. It became evident that most of the regulations are based on already existing standards - mainly those of the US. The new European Norm EN 14 375 for child-resistant non-reclosable pharmaceutical products from February 2004 is described, explained and the efforts to harmonise the national differences in this field are discussed.

This thesis also tries to explain the necessity for these regulations and the attempt of the pharmaceutical industry and the authorities to protect inquisitive children from intoxication by medicinal products, while at the same time trying to ensure that blister packs remain easy to open for older adults.

In this connection the role of Poison Information Head Offices in Germany is introduced and some statistics about intoxication with children are given.

To illustrate, how child-resistant blister packs work, some commonly used child-resistant blister foils and materials are presented and discussed.

Finally the thesis discusses the development of child-resistant packaging, the greater effort that has been focussed on cases where the goal is to avoid child poisonings in households or at least to help to reduce the incidence of such cases - through parents being informed and with sensible, preventive measures such as positioning the family medicine-chest out of children´s reach.

Pages: 34