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pharmacystudy material

Containers for parenteral:

Glass containers:
• Glass is the preferred material for containers for injectable products.
• It is principally composed of silicon dioxide tetrahedron which is modified using oxides like sodium, potassium, calcium etc.

Types of glass:

  1. Type1: Highly resistant borosilicate glass
  2. Type2: Treated soda lime glass
  3. Type3: Soda lime glass
  4. Type4: General purpose glass
    • Generally type1 glass is used for most of the sterile products.
    • But type 2 and Type 3 glass can also be used when product has non aqueous vehicle.
    • The protection of light sensitive drugs can be done by use of amber colored glass which is achieved by iron oxides.
    • But iron oxides leach out in the product hence amber colored container should not be used in case of product which has iron catalyzed chemical.
    • The glass should have sufficient mechanical strength to withstand high pressure during autoclaving and abuse during processing.

Sterile products made by glass:
Ampules:
• These are single dose containing formulations.
• Generally Type 1 glass is used.

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Vials:
These are used for multi dose parenteral products and provided with closure followed by aluminum seal to ensure the air tight packing.

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Plastic containers:
Advantages:
• Light in weight
• Non breakable
• Has low toxicity
• Low reactivity with products

Disadvantages:
• Tissue toxicity can occur
• Reactivity due to sorption
• Leaching

Plastic is of two types:
Thermoplastic :

  1. Polyethylene
  2. LDPE (Low density polyethylene)
  3. HDPE (High density polyethylene)
  4. Polypropylene
  5. Polyvinyl chloride
  6. Polystyrene
  7. Polyamide (Nylon)
  1. Thermosets:
  2. Melamine
  3. Phenol formaldehyde
  4. Urea formaldehyde
    • The two plastics have more interest in parenteral field that is polypropylene and copolymer polyethylene and polypropylene.
    • Polypropylene is mostly used plastic because it has high tensile strength, high melting point (165°c) and low permeability to gases and water vapors.
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Rubber:
• Rubber closures are mostly used to seal the opening of cartridges, vials, bottles and to provide soft and elastic permit to enter and withdrawn of a needle without loss of integrity of container.
• Principle unit of rubber closure is latex and vulcanizing agent, accelerator, activator, filler etc are added.
• Closures should be non- reactive with the product.
• Physical properties of rubber are elasticity, hardness, porosity.
• Sometimes plastic or lacquer coating is also done to rubber to prevent the sorption, vapor transfer and to provide complete barrier as desired.