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Pharmaceutical packaging is the package and packaging process for pharmaceutical preparations. It involves all activities from manufacturing to the end consumer through the drug distribution channel.
Pharmaceutical packaging is highly regulated but with some variation in detail, depending on the country or region of origin. A number of common reasons may include: assurance of patient safety, assurance of drug efficacy through intended shelf life, uniformity of drug across different manufacturing lots, thorough documentation of all materials and processes, control of potential migration of packaging materials. Control of drug degradation by drugs, oxygen, moisture, heat, etc., prevention of microbial contamination, sterility, etc. Packaging is often associated with the distribution, dosage and use of pharmaceutical products. Proper use communication and warning labels are also regulated. Packaging is an integral part of pharmaceutical products.
Pharmaceutical packaging can often be thought of by segments of the delivery system and functions required by the user of the package. Packaging requirements vary. Bulk pharmaceuticals can be sent to other pharmaceutical companies for further processing, to contract packagers for unit pack manufacturing, to international customers, etc. Bulk shipments in fiber drums (with plastic liners), bulk boxes, corrugated boxes with liners, intermediate bulk containers, and other shipping containers.
Smaller bulk packs can be sent to pharmacies, especially compounding pharmacies. Liquid or powder can be measured and placed in the primary package.
Blister Pack
Formed solid unit doses of pharmaceuticals (capsules, suppositories, tablets, etc.) are usually packed in blister packs. About 85% of solid unit doses are packed in blister packs in Europe and only 20% in North America. Blister packs are pre-formed plastic/paper/foil packaging used for formulated solid drugs. The primary component of a blister pack is a cavity or pocket made from a thermoformed plastic. It usually has a paperboard backing or a lid seal of aluminum foil or plastic film. Blister packs are useful for protecting medicines against external factors, such as moisture and contamination for long periods of time. Blister packing equipment is readily available and suitable for validation processes.
Bottles
Bottles are commonly used for liquid medications as well as ready-made tablets and capsules. Glass is the most common for liquids because it is inert and has excellent barrier properties. Various types of plastic bottles are used by both drug manufacturers and pharmacists in pharmacies. Prescription bottles have been around since the 19th century. Throughout the 19th and 20th centuries, prescription drug bottles were called medicine bottles. Prescription bottles come in many styles and sizes. Bottles often contain cotton to cushion powdery, breakable pills. In modern times, pills are coated, and thus no longer need to include a cotton ball. The US National Institutes of Health advises consumers to remove cotton balls from open pill bottles, as cotton balls can attract moisture into the bottle.
Prescription bottles come in a variety of colors, the most common being orange or light brown due to their ability to prevent ultraviolet light from degrading potentially photosensitive contents through photochemical reactions, while still allowing enough visible light to enter to easily visualize the contents. . Other common colors include: clear (for compounds that do not degrade in light), blue, dark brown, green, and various opaque colors.
