The materials from which the packaging for the medical and pharmaceutical industries is made must comply with the requirements specified in the relevant regulatory documents.
Primary requirements
Criteria for choosing high-quality packaging for medicines and materials:
- Keeping products sterile. Since medical products must be transported and stored until the immediate moment of use, the packaging must provide a barrier for pathogenic microorganisms that violate the sterility of the medical device or its part.
- Compatibility with components of medicinal substances and materials. The components of packaging materials should not enter into chemical reactions that change the formulation of medicines. The converse requirement is also true.
- Reliability. The packaging must protect medicinal products and materials, for example those sensitive to direct sunlight or containing volatile substances, from interaction with the environment in order to maintain the original properties of the product or the shelf life.
The use of polymer packaging in medicine is due to such properties as: strength, chemical inertness, resistance to moisture, light, ease of processing and versatility. It is worth noting that polymers are most often included in the primary packaging (blisters, bottles, tubes and other forms in contact with the active substance).
Varieties of polymers
Manufacturers use a wide range of polymers as packaging materials, but the most common are:
- polypropylene. This polymer accounts for about 21% of all pharmaceutical packaging material. It is a strong compound that is resistant to heat, chemicals, grease and oil. It is part of almost all primary packaging of medical products, from vials and ampoules to tubes and syringes;
- polystyrene. Easily formable universal polymer. It is widely used in the formulations for the production of lids for packaging containers;
- polyethylene terephthalate. Differs in lightness, transparency, strength, good barrier properties for liquid and gas. It is used for the manufacture of bottles in which medicines are poured; recyclable;
- high strength polyethylene. Semi-rigid packaging is made from this polymer, for example, vials, tubes and bottles. One of the most inert materials, durable, moisture resistant, easy to process, recyclable.