Plastic flexible packaging is commonly utilized in the pharmaceutical industry. They serve as "protective suits" for medications, attempting to block external environmental variables (oxygen, moisture, light) while guaranteeing the stability, safety, and efficacy of the medicines during their validity period. Because of the unique nature of medications, these packaging materials are typically multi-layered composite structures that must meet a variety of criteria, including barrier characteristics, heat resistance, and mechanical strength. Choosing the appropriate type of plastic soft packaging for medicine packaging materials necessitates close collaboration between pharmaceutical firms and expert packaging material manufacturers, as well as a thorough assessment and verification based on the medicines' specific requirements.
Selecting plastic flexible packaging materials for medicines is a meticulous task, which usually requires considering multiple factors and undergoing rigorous verification:
Product characteristics: include dosage form (tablet, capsule, granule, powder, liquid, ointment, etc.), pH value, chemical properties of the ingredients (whether prone to oxidation, moisture absorption, light sensitivity, etc.), and compatibility of the drug (ensuring that the packaging materials do not interact with the drug).
Protection requirements: determine the barrier grade of the packaging based on the sensitivity of the drug to oxygen, water vapor, and light. For example, drugs that are highly prone to oxidation or moisture absorption need to choose PVDC coated film or aluminum-plastic composite and other high-barrier materials.
Sterilization methods: The packaging of the drug may need to withstand different sterilization treatments (such as high-temperature steam sterilization, ethylene oxide sterilization, irradiation sterilization), and the packaging materials must have corresponding heat resistance and sterilization resistance capabilities.
Process and cost: The heat sealing performance, mechanical strength (adaptability to high-speed automated filling equipment), and cost of the packaging material are also factors to be considered.
Regulations and compliance: Drug packaging materials must comply with the regulatory requirements of the country or region where they are used (such as the registration and review requirements of China's NMPA, the US FDA, and the EU EMA), ensuring their safety, non-toxicity, and no pollution, and providing sufficient data to prove their compatibility with the drug.
The flexible packaging of pharmaceuticals is mostly of a composite structure to achieve the performance that a single material cannot achieve. For example:
BOPP/VMPET/PE: Possessing excellent barrier properties and decorative features, they are commonly used for general pharmaceutical packaging.
PET/AL/PE: Exhibiting extremely high barrier properties, they are often used for packaging with higher requirements for pharmaceuticals.
PVC/AL: A common blister packaging structure, used for single-dose packaging of tablets and capsules.
Paper/AL/PE: Often used for packaging of powder and tablets.
Plastic flexible packaging for pharmaceuticals will eventually be transformed into various forms of packaging, including but not limited to:
Composite film bag: Used for the intermediate or outer packaging of granules, powders, powders for oral administration, capsules, etc.
Blister packaging (PTP): Commonly used for single-dose packaging of tablets and capsules, facilitating access and portability.
Infusion bag: A soft bag made of multi-layer co-extruded film, used for intravenous infusion.
Ointment tube: Used for packaging semi-solid preparations such as ointments and gels.
