Packaging may be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use.
The aspects of packaging to be considered include:
- the functions of packaging;
- the selection of a packaging material;
- the testing of the material selected;
- filling and assembling;
- storage and stability.
Packaging materials include printed material employed in the packaging of a pharmaceutical product, but not any outer packaging used for transportation or shipment.
A distinction must be made between primary and secondary packaging components. The primary packaging components are in direct physical contact with the product, whereas the secondary components are not (e.g. aluminium caps, cardboard boxes).
The choice of primary and/or secondary packaging materials will depend on the degree of protection required, compatibility with the contents, the filling method and cost, but also the presentation for over-the-counter (OTC) drugs and the convenience of the packaging for the user.
Both single-dose and multi-dose containers exist. Containers may be well-closed, tightly closed, hermetically closed or light-resistant.
The packaging process, is the process that a bulk material must undergo to become a finished product. The properties and attributes of the product should be as specified by the manufacturer and required by the user.
The packaging process consists of the following stages:
— filling and assembling;
— sterilization in the final container, if applicable;
— placing labels on the container;
— storage at the manufacturing and shipping sites.
Packagingdocumentation includes aspects related to:
— specifications and quality control, including batch records;
— labels, inks and adhesive materials (e.g. glue);
— package inserts for patients.
Apart from primary and secondary packaging, two types of special packaging are currently in use, as follows:
- Unit dose packaging: This packaging guarantees safer medication by reducing medication errors; it is also more practical for the patient. It may be very useful in improving compliance with treatment and may also be useful for less stable products.
- Device packaging: Packaging with the aid of an administration device is user-friendly and also improves compliance. This type of packaging permits easier administration by means of devices such as prefilled syringes, droppers, transdermal delivery systems, pumps and aerosol sprays. Such devices ensure that the medicinal product is administered correctly and in the right amount.
- Guidelines on Packaging for Pharmaceutical Products | Part I
- Guidelines on Packaging for Pharmaceutical Products | Part III
Reference: WHO Technical Report Series, No. 902, 2002- Annex 9
Resource Person: BARBARA PIROLA