Child resistant closures (CRC) have been designed to protect young children from harmful substances. Their use has become widespread especially in the USA further to the Poison Prevention Packaging Act (PPPA).
The PPPA defines special child resistant packaging as: "Packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of substance contained therein within a reasonable time and not difficult for normal adults to use properly."
Since the PPPA was established in 1970 for pharmaceutical packaging, the number of children poisoned each year has been falling steadily. In the US, CPSC (Consumer Product Safety Commission) estimates that child-resistant packaging for aspirin and oral prescription medicine has saved many lives . Indeed, according to National Center for Health Statistics, poisoning deaths of children under 5 have dropped to under 40 in 2000, while this number was 216 in 1972.
Regulatory Landscape
In the USA, the 16 CFR § 1700.14 mandates all oral prescription drugs and a list of OTC drugs such as aspirin to use special packaging.
The Poison Prevention Packaging Act was amended in 1995 to include requirements on senior friendly performance.
Today, the test methods defined in 16 FR§1700.20 require to test both with children aged from 42 to 51 months and adults from 50 to 70 years old.
In Western Europe, CR closures will witness a higher demand in forecast years due to new regulation standards .
The European directives 1999/45/EC and 1967/54/EEC are the legal bases for child resistant packaging of dangerous substances and preparations. They are transposed into national law.UK, Germany, Italy and Netherland are the countries most developed in CR closures.
In UK, the statutory requirements are set out in The Medicines (Child Safety) Regulations 2003[SI2003/2317]. Medicines containing aspirin, paracetamol and more than 24mg of elemental iron must be placed on the market in packaging which has been shown to be child resistant.
In Germany, following the Ordinance on Hazardous Substances, drugs have to be packaged in a child resistant manner if their ingredients are regulated under section 28 of the German Medicine Act.
In Europe, all CRCs test results should meet the requirement of European Committee for Standardization EN 28317 (2004), equivalent to ISO 8317 (2004). Other regulations for CRCs in world wide include CSA Z76.1 (c) in Canada.
Solutions
New regulation standards encourage and force pharmaceutical companies to adopt better packaging design to ensure it meets the criteria in terms of usability, child resistance and protection from potentially harmful environmental factors.
New standards have been updated over the years, three basic systems are used to ensure the resistance. The first is the 'push-and-turn', where two opposing actions are demanded, which is difficult for children but easy for adult; these closures rely on torque force for opening and closing--'squeeze-and-turn', but less easy for adult patients to open. The second is the 'line up the arrows' and similar system, where a barrier of cognizance as opposed to dexterity is used. The push-and-turn systems have the advantage to fit on standard bottles in a variety of shapes, materials and sizes as opposed to the other types that require bottles to have matching features.
In the USA, the standard caps include a liner that will be sealed to the container during the filling operation. The liner will ensure tamper evidence and seal. In Europe, the tamper evidence is typically ensured by a breakable plastic ring and the cap is designed to ensure a good seal. This design without liner allows the integration of desiccant in the cap to eliminate moisture in the bottle.
Visible trends
CRCs technology innovations will develop towards more adult friendly design as up to 90 per cent of adults struggle to open child-proof packaging, according to the journal of the Engineering and Physical Sciences Research Council.. Among the consequences, are that some patients leave the bottle open, allowing easy access for children.
Different solutions have been studied and implemented. Closures that can be opened and closed with less than one turn, or caps requiring low application and removal torque. In addition, the ergonomic of the cap needs to be optimized. Other improvements are linked to confirming the closing of the closure by an audible and/or tactile click and a positive stop.
The progression of the child resistant closures has been driven by regulatory. Cost and ergonomic have slowed their progress beyond this scope. However, the impact of their implementation in the USA has demonstrated its power to save lives. Today, the manufacturers of closures have introduced innovative cost-effective solutions that allow to protect children while making it easy for adults and senior. We can then expect child resistant closures to develop more outside of the USA in the near future.
(The author is managing director, Rexam Pharma Packaging India - a leading supplier of pharmaceutical primary packaging for both domestic and regulated markets.)