BY PACKAGING


Glass Containers

Advantages:

  1. Superior protective qualities
  2. Economical
  3. Readily available in a wide variety of sizes & shapes
  4. Essentially chemically inert, impermeable, strong and rigid
  5. Has FDA clearance
  6. Does not deteriorate with age
  7. Provides an excellent barrier against every element except light with a proper closure system. Colored glass, especially amber, can give protection against light.

Disadvantages:

  1. Fragility
  2. Heavy Weight.

Composition of glass

  1. Sand – pure silica
  2. Soda-ash – sodium carbonate
  3. Limestone – calcium carbonate
  4. Cullet – broken glass that is mixed with the batch & acts as a fusion agent for the entire mixture.

The most common cations found in pharmaceutical glassware are silicone, aluminum, boron, sodium, potassium, calcium, magnesium, zinc & barium. The only anion of consequence is oxygen.

Type I: Borosilicate Glass

  • Highly resistant glass
  • A substantial part of the alkali & earth cations are replaced by boron and/or aluminum & zinc.
  • It is more chemically inert than the soda-lime glass (which contains either none or an insignificant amount of these cations).
  • It is used to contain strong acids & alkalies as well as all types of solvents.
  • The addition of approx 6% boron to form type I glass reduces the leaching action.

Type II: Treated Soda-Lime Glass

  • When glassware is stored for several months, especially in a damp atmosphere or with extreme temperature variations, the wetting of the surface by condensed moisture (condensation) results in salts being dissolved out of the glass. This is called “blooming” or “weathering” & it gives the appearance of fine crystals on the glass.
  • Type II containers are made of commercial soda-lime glass that has been de-alkalized or treated to remove surface alkali.
  • The  de-alkalizing  process  is  known  as  “sulfur  treatment”  and  virtually  prevents “weathering” of empty bottles.
  • Some manufactures expose the glass to an atmosphere containing water vapor & acidic gases. This results in a reaction between gases & surface alkali, which makes it resistant to attack by water.
  • The alkali removed from the glass appears on the surface as a sulfate bloom, which is removed when the containers are washed before filling.

Type III – Regular Soda-Lime Glass

  • Containers are untreated & made up of commercial soda-lime glass of average or better-than-average chemical resistance.

Type NP – General Purpose Soda-Lime Glass

  • Containers made up of soda-lime glass are supplied for non-parenteral products, those intended for oral or topical use.

 

PACKAGE TYPE

TYPE OF FORMULATION CAN BE PACKED

MINIMUM QUALITY OF GLASS THAT CAN BE USED

Ampoule

Aqueous Injectables Of Any pH

Type I

Aqueous Injectables Of pH Less Than 7

Type II

Non-Aqueous Injectables

Type III

Vial

Aqueous Injectables Of Any pH

Type I

Aqueous Injectables Of pH Less Than 7

Type II

Non-Aqueous Injectables

Type III

Dry Powders For Parenteral Use (Need To Be Reconstituted Before Use)

Type IV

Bottles and Jars 

Tablets, Capsules, Oral Solids & Other Solids For Reconstitution

Type IV

Oral Liquids (Solutions, Suspensions, Emulsions)

Type IV

Nasal & Ear Drops

Type IV

Certain Types Of External Semisolids (Rubeficients, Local Irritants)

Type IV

Blood & Related Products

Type I