Pharmaceutical Packaging Materials

Sterilization Methods

• Radiation sterilization has a disadvantage of requiring a large facility, high capital investment, and risk of degrading polymer-based packaging materials when not properly calibrated.
• FDA 21 CFR 179.45 lists packaging materials and radiation dosages.

Types of Radioactive Sterilization

• X-rays are a favorable alternative to e-beams and gamma radiation, with similar antimicrobial properties and higher penetration depth than e-beams.
• Electron beams use a stream of accelerated electrons to deactivate surface microorganisms, but have high maintenance, operation, and setup costs (FDA 21 CFR 179.26).
• Ultraviolet (UV) light is an electromagnetic radiation with a wavelength of 10400nm, with types including UV-A (315-400nm), UV-B (280-315nm), and UV-C (100-280nm), with UV-C typically used for sterilization.

Thermal Sterilization

• Thermal sterilization is the oldest and most widely available method worldwide, with two main principles: dry heat and moist heat.
• Dry heat sterilization increases the temperature of an object through heat transfer from a heat source.

Sterilization Process

• Sterilization is a technique used to treat products or processes, categorized into three types: radiation (gamma, electron beam, x-ray, and UV), thermal (dry and moist heat), and chemical (ethylene oxide, ozone, chlorine dioxide, and hydrogen peroxide).
• Radiation targets microbial DNA and is useful for heat-sensitive products.

Radiation Types

• There are two types of radiation: ionizing and non-ionizing.
• Ionizing radiation uses shorter wavelengths with high-intensity radiation, destroying microorganisms (gamma and x-ray, which are reactive to human DNA, resulting in damaged cells).
• Non-ionizing radiation uses longer wavelengths and lower energy, not penetrating substances, and is used for sterilization of surfaces (UV and electron beam).

Gamma Ray Sterilization

• Gamma rays are usually used for single-use pharmaceutical products, characterized by ease of use and compatibility with diverse packaging materials.

Pharmaceutical Packaging

• The combination of components necessary to contain, preserve, protect, and deliver a safe and efficacious drug product is considered pharmaceutical packaging.
• Criteria for selecting packaging type and material include stability, compatibility with contents, strength, moisture resistance, corrosion resistance, and aesthetic appeal.

Packaging Materials

• Glass has superior protection qualities, is economical, and has excellent barrier properties, but is fragile and heavy.
• Type I glass (borosilicate glass) is highly resistant and chemically inert.
• Type II glass (treated soda-lime glass) is surface-treated with sulfur to make it chemically resistant.

Cotton in Packaging

• Cotton is used as wadding to prevent collision of individual units or absorb moisture, or as a desiccant to absorb moisture from the environment.

Adhesives and Inks in Packaging

• Labels play a crucial role in pharmaceuticals, providing essential information.
• Adhesives protect against counterfeit and distribution hazards.

Closures in Packaging

• The purpose of closures is to protect the drug container after filling, ensuring easy and safe administration of the drug.
• Basic designs of closures include screw-on (threaded or lug) and moisture-resistant closures.

Chemical Sterilization

• Ethylene oxide is used as a fumigant and has applications in consumer goods production (antifreeze, adhesives, and detergents).
• Ozone is used for sterilization and requires a special equipment (ozone generator).
• Chlorine dioxide is used as a disinfectant for water and water-based substances.
• Hydrogen peroxide is a strong and fast-acting sterilant with the advantages of ease of application, non-toxicity, odorlessness, and environmental friendliness.