Containers child-resistant closure

Current good manufacturing practice requirements for the control of drug product containers and closures are included in 21 CFR Parts 210 and 211. The U.S. Food and Drug Administration (FDA) requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission requirements for child-resistant closures are included in 16 CFR 1700. 

Packaging requirements can include child resistant closures, the word POISON being embossed along the side of the packaging so that the container can be identified by visually impaired people or in the dark. 

Although there are no EU requirements for child-resistant closures for medicines, there are directives (91/442 and 90/35) which require containers for products that are toxic or corrosive to be made child-resistant. For pharmaceutical products individual countries have introduced requirements for example, the Pharmaceutical Society of Great Britain requires in its code of practice that all solid and liquid preparations be dispensed in reclosable child-resistant containers, unless ... 

Finally, containers can be diaphragm sealed using heat (including induction sealing) or adhesive either as the sole closuring means (i.e. peelable tops for unit dose preparations) or in conjunction with any of the other closures previously mentioned. Diaphragms can be a useful means of forming a tamper-evident seal, e.g. used in conjunction with a child-resistant closure. 

Containers must be clean, sound and fit for the intended purpose. Where possible pharmacies will fit child resistant closures (CRCs) and these must be used for medicines containing aspirin and paracetamol. Fluted bottles must be used for medicines that are for external use only. Patient information leaflets or summary of product characteristics must be included. Their content is set out by law. 

Adding or changing a child-resistant closure, changing from a metal to plastic screw cap, or changing from a plastic to metal screw cap Changing from one plastic container to another of the same type of plastic (e.g., high-density polyethylene container to another high-den-sity polyethylene container)... 

Until recently, there was little evidence as to whether blister packs were as effective in preventing poisonings as child resistant closures. However, a recent study in the United Kingdom found that medications involved in poisonings were most frequently packed in containers without child resistant closures (63%) or transparent blisters (20%). Conversely, child resistant closures, foil strips, sachets and opaque blister packs had low associations with poisoning incident [17]. 

Unfortunately, this campaign does not address the issue of child resistant packaging for scheduled toxic substances. The Toxic Substances Board (an advisory committee to the Minister of Health) recommended that the Ministry adq)t their proposed draft legislation amending the Toxic Substances Regulations such that child resistant closures would be required for certain scheduled chemicals including pesticides with container capacities <2.5 1. Currently, this remains unactioned. 

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 

The next largest molded product market for PP is packaging, especially closures and containers. Child-resistant, tamperproof, linerless features are important design factors as also inherent chemical resistance, stress-crack resistance, and high productivity at low cost. Housewares utilize random copolymers for refrigerator and shelf-storage containers and lids. Medium-impact copolymers are used for hot/cold thermos containers, lunch boxes, coolers, and picnic ware. 

Tamper-evident closures are used to prevent customers from opening containers before they buy them. Several tamper-evident features were originally introduced including neck bands, tamper-rings, and shrink wrapping. More recently, a number of new tamper-evident and child-resistant closures (CRC) have been introduced. 

It is not always possible to develop a container that satisfies all the necessary requirements. Certain requirements can coimteract each other such as child-resistant closure versus user friendliness and impermeability versus weight. Specific requirements for different types of containers will be described in separate paragraphs (see Sect. 24.4). 

Some have to be fitted with a child-resistant closure to a laydown standard to prevent young children opening containers and swallowing the contents. 

The integrity of the container and its closure should be discussed. Factors such as child resistance or tamper evidence, etc., should be discussed. The PhEur includes a requirement for certain types of product to be supplied in tamper proof container-closure system-s—which is not possible if the product is to be used by a patient ... 

The information on the container and the development pharmaceutics is to cover the qualitative composition (polymeric and other), closure type and method of operation, tightness of the closure, dosing device information, tamper evidence and child resistance, stability of the product in the container, the method of administration of the medicinal product, any sterilization procedures, the ability of the container to protect the contents from external factors,... 

In addition to the material and the package style, the closure is critical to the proper performance of the packaging system. In fact, many of the novel characteristics of a container are housed in the closure-child-resistant packaging, tamper-evident seals, pour spouts, etc. Furthermore, without the proper selection of closure, even the most well-designed package is likely to fail. 

Before other functions, e.g. tamper-evidence/resistance, child-resistance, accuracy of delivery, can be discussed, general technical factors associated with ingress and egress need further consideration. Since these are common to seal efficiency (i.e. ingress and egress) and may define seal quality, they were not covered under the headings used earlier. In the example used below a continuous screw threaded container—closure system has been employed as an indication of the typical variables involved. These are listed in Table 11.2 and then briefly discussed. 

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