In the intricate and highly regulated landscape of the pharmaceutical industry, patient safety is an aspect that unequivocally stands out in its importance. A cornerstone of this safety lies in the design and implementation of product packaging, with a particular emphasis on child-resistant closures. These solutions are meticulously designed and rigorously tested to deter accidental opening by children, significantly mitigating the risk of poisoning incidents resulting from unintentional ingestion.
Despite considerable advancements in packaging design, the introduction of stringent regulatory measures, and increased public awareness, cases of poisoning from accidental ingestion by children persist as a significant health concern. A report by the U.S. Consumer Product Safety Commission1 alarmingly indicates that pediatric poisoning continues to be a leading cause of injury and fatality among children. This ongoing issue underscores the urgent need for further innovation, vigilance, and education in the realm of child-resistant packaging.
The regulatory landscape for child- resistant packaging is diverse and varies across different regions globally. In the United States, the landmark Poison Prevention Packaging Act of 1970 laid down specific requirements for the packaging of a wide array of household and pharmaceutical products. This was a significant step towards ensuring the safety of children from potentially harmful substances. Across the Atlantic, in Europe, UNI regulations establish standards for child-resistant packaging, including ISO 13127:2012, UNI EN ISO 8317:2016, UNI EN 14375:2016, and UNI CEN/TR 16353:2013. These standards provide a robust framework for manufacturers, guiding them in the creation of packaging that ensures both the safety and efficacy of child-resistant mechanisms.
Historically, the concept of child- resistance has been primarily applied to primary packaging closure systems, such as bottle caps. The most prevalent systems on the market include “Turn and Lift”, “Push and Turn”, and “Squeeze and Turn” features. These designs require a sequence of movements that are difficult for a young child to perform, thereby preventing accidental opening. However, the evolving needs of the pharmaceutical industry, coupled with increasing awareness about child safety, have led to the emergence of child-resistant solutions for blister packs and other types of secondary packaging. This expansion reflects the industry’s commitment to safety across all forms of pharmaceutical packaging.
Designing a child-resistant capsule involves careful consideration of multiple factors. It’s a complex process that requires a deep understanding of the needs of the patient, the operational requirements of the pharmaceutical industry, and the regulatory landscape. Bormioli Pharma, a pioneer in this field, was among the first players to introduce child-resistant capsules in the market. The company restlessly continues to innovate and evolve its offerings to meet the dynamic needs of patients and industry, demonstrating an unwavering commitment to safety.
While engineering a child-resistant capsule, the industrial needs of our customers should also be considered. Indeed, pharma companies require a robust product suitable to be repeatable in industrial processes, that 100% of production has already been checked with automatic vision systems confirming improved capping performance to avoid in-line failures.
