Guidelines on Packaging for Pharmaceutical Products
All medicinal products need to be protected and “consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents. However, the limits of acceptability in these various respects depend, at least in part, on climatic variables. Recommendations in The international pharmacopoeia can only be advisory; precise quantitative standards will have to be locally determined”
The complexity of packaging materials and the highly technological nature of medicinal products is such that manufacturers are confronted with significant problems. Interaction between packaging and such products is possible due to the combination of a multiplicity of container components and active pharmaceutical ingredients, excipients and solvents used in a variety of dosage forms.
The quality of the packaging of pharmaceutical products plays a very important role in the quality of such products.
— protect against all adverse external influences that can alter the properties of the product, e.g. moisture, light, oxygen and temperature variations;
— protect against biological contamination;
— protect against physical damage;
— carry the correct information and identification of the product. The kind of packaging and the materials used must be chosen in such a way that:
— the packaging itself does not have an adverse effect on the product (e.g. through chemical reactions, leaching of packaging materials or absorption);
— the product does not have an adverse effect on the packaging, changing its properties or affecting its protective function.
The resulting requirements must be met throughout the whole of the intended shelf-life of the product. Given the link between the quality of a pharmaceutical product and the quality of its packaging, pharmaceutical packaging materials and systems must be subject, in principle, to the same quality assurance requirements as pharmaceutical products.
Types of Containers for pharmaceuticals:-
A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only.
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.
A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded.
A container with a more or less pronounced neck and usually a flat bottom.
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).
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.
A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms.
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.
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.
A container for single doses of solid, semi-solid or liquid preparations.
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.
A container for multi-dose semi-solid pharmaceutical forms consisting of collapsible material; the contents are released via a nozzle by squeezing the package.
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.
Formally authorised Packaging instructions should exist for each product, pack size and type.
These should normally include, or make reference to:
the name of the product;
- a description of its pharmaceutical form, strength and, where applicable, method of application;
- the pack size expressed in terms of the number, weight or volume of the product in the final container;
- a complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the code or reference number relating to the specifications for each packaging material;
- where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked;
- Special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations;
- a description of the packaging operation, including any significant subsidiary operations, and equipment to be used;
- details of in-process controls with instructions for sampling and acceptance limits.
Functions of packaging
The containment of the product is the most fundamental function of packaging for medicinal products. The design of high-quality packaging must take into account both the needs of the product and of the manufacturing and distribution system. This requires the packaging:
— not to leak, nor allow diffusion and permeation of the product;
— to be strong enough to hold the contents when subjected to normal handling;
— not to be altered by the ingredients of the formulation in its final dosage form.
The packaging must protect the product against all adverse external influences that may affect its quality or potency, such as:
— biological contamination
— mechanical damage.
WHO Annex 9 Guidelines on Packaging for pharmaceutical Products.