Packaging is defined as a technique which allows containment of pharmaceutical product from the time of production in a unit till its use. Role of pharmaceutical packaging is to provide lifesaving drugs, surgical devices, blood and blood products, nutraceuticals, powders, poultices, liquid and dosage forms, solid and semisolid dosage forms. Packaging of pharmaceuticals essentially provides containment, drug safety, identity, convenience of handling and delivery.
A container for pharmaceutical use is an article which holds or is intended to contain and protect a drug and is or may be in direct contact with it. The closure is a part of the container. The container and its closure must not interact physically or chemically with the substance within in any way that would alter its quality. The following terms include general requirements for the permeability of containers.
• Well-closed containers must protect the contents from extraneous matter or from loss of the substance under normal conditions of handling, shipment or storage.
• Tightly closed containers must protect the contents from extraneous matter, from loss of the substance, and from efflorescence, deliquescence or evaporation under normal conditions of handling, shipment or storage. If the container is intended to be opened on several occasions, it must be designed to be airtight after reclosure.
• Hermetically closed containers must protect the contents from extraneous matter and from loss of the substance, and be impervious to air or any other gas under normal conditions of handling, shipment or storage.
Substances and dosage forms requiring protection from light should be maintained in a light-resistant container that either by reason of the inherent properties of the material of which it is composed, or because a special coating has been applied to it shields the contents from the effects of light. Alternatively, the container may be placed inside a suitable light-resistant (opaque) covering and/or stored in a dark place
Ampoule: A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only.
Bag: A container consisting of surfaces, whether or not with a flat bottom, made of flexible material, closed at the bottom and at the sides by sealing; the top may be closed by fusion of the material, depending on the intended use.
Blister: A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded.
Bottle: A container with a more or less pronounced neck and usually a flat bottom.
Cartridge: A container, usually cylindrical, suitable for liquid or solid pharmaceutical dosage forms; generally for use in a specially designed apparatus (e.g. a prefilled syringe).
Gas cylinder: A container, usually cylindrical, suitable for compressed, liquefied or dissolved gas, fitted with a device to regulate the spontaneous outflow of gas at atmospheric pressure and room temperature.
Injection needle: A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms.
Injection syringe: A cylindrical device with a cannula-like nozzle, with or without a fixed needle and a movable piston, used for the administration, usually parenteral, of an accurately measured quantity of a liquid pharmaceutical form. The syringe may be prefilled, and can be for single-dose or multi-dose use.
Pressurized container: A container suitable for compressed, liquefied or dissolved gas fitted with a device that, after its actuation, produces a controlled spontaneous release of the contents at atmospheric pressure and room temperature.
Single-dose container: A container for single doses of solid, semi-solid or liquid preparations.
Strip: A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations. Blisters are excluded.
Tube: A container for multi-dose semi-solid pharmaceutical forms consisting of collapsible material; the contents are released via a nozzle by squeezing the package.
Vial: A small container for parenteral medicinal products, with a stopper and overseal; the contents are removed after piercing the stopper. Both single-dose and multi-dose types exist.
Closures used for the purpose of covering drug containers after the filling process should be as inert as possible. They should not give rise to undesired interactions between the contents and the outside environment, and should provide a complete seal. Besides their protective function, closures must also allow the easy and safe administration of the drug.
Depending on the application, closures may have to be pierced with a needle for intravenous sets. Such closures are made from elastomeric materials (rubbers), while those that cannot be pierced are generally made from plastics such as polyethylene or polypropylene.
Depending on the type of container, closures may have different shapes and sizes, e.g. stoppers for infusion or injection bottles or plungers for prefilled syringes. A special design of stopper may also be required for some pharmaceutical production processes such as lyophilization.
Rubber consists of several ingredients, one of which is elastomer. Modern rubber compounds used in packaging pharmaceuticals contain only a limited number of ingredients, which are very difficult to extract. Closures made from such materials generally do not pose any problems, and can be used in contact with a large number of drug preparations.
Rubber closures for pharmaceutical use must meet the relevant requirements of the most important pharmacopoeias (the European, Japanese and United States pharmacopoeias). International standards have also been established (ISO 8871). It should be emphasized that the requirements of pharmacopoeias and standards must be seen as minimal requirements
Caps or overseals
Caps or overseals are used to secure the rubber closure to the container in order to maintain the integrity of the seal under normal conditions of transport, handling and storage during the intended shelf-life of the product. Such caps are usually made of aluminium and can be equipped with a plastic top to facilitate opening. Caps also provide evidence of tampering: once opened or removed they cannot be repositioned. This is especially true for caps with a plastic top.
Tampering includes three aspects, namely altering, pilfering and falsifying the pharmaceutical product. To prevent tragic accidents and especially malicious tampering, manufacturers try to create safe packaging and governments continue to update regulations to include new tamper-evident technology.
Tragic accidents involving the drug intoxication of children has led to new legislation making it difficult for drug packaging to be opened by young children, while allowing adults easy access. Such packaging is designated as child-resistant. The use of child-resistant packaging has proved effective in reducing child mortality from intoxication by oral prescription drugs, and it is now recognized worldwide that children must be protected against such intoxication.