Selection Criteria
Material Compatibility: Containers and closures must not interact chemically with the formulation.
Sterility: They should be capable of maintaining sterility throughout the product's shelf life.
Physical and Chemical Properties: Resistance to breakage, moisture, light, and temperature fluctuations.
Ease of Administration: Containers should allow easy withdrawal of the product or direct administration.
Regulatory Compliance: Containers and closures must comply with pharmacopeial and regulatory guidelines.
Types of Containers
Glass Containers:
Used for ampoules, vials, and bottles.
Made of Type I (borosilicate glass), Type II, or Type III glass.
Advantages:
Chemically inert and impermeable.
Resistant to thermal shock (Type I).
Disadvantages:
Fragile and prone to breakage.
Plastic Containers:
Used for infusion fluids (e.g., flexible plastic bags).
Made of materials like polypropylene or polyethylene.
Advantages:
Lightweight, shatterproof, and flexible.
Disadvantages:
Potential for leaching of plasticizers.
Types of Closures
Rubber Stoppers:
Used in vials.
Composed of butyl, silicone, or natural rubber.
Should be inert and elastic for proper sealing.
Flip-Off Caps and Aluminum Seals:
Provide tamper-evidence for vials.
Sealing Membranes:
Used in flexible plastic bags.