Packaging Technology

DEFINITION: 

Packing: Packing consists of enclosing an individual item, or several items, in a container, usually for shipment or delivery. This operation is mostly done by hand and machine. Pharmaceutical

Packaging: Pharmaceutical packaging means the combination of components necessary to contain, preserve, protect & deliver a safe, efficacious drug product, such that at any time point before expiration date of the drug product, a safe & efficacious dosage form is available.

Types of Packaging Systems: 

1.  Primary package system: Made up of those package components & subcomponents that come into direct contact with the product, or those that may have a direct effect on the product shelf life. 
2. Secondary or tertiary package system: Includes cartons, corrugated shippers & pallets

Packaging must meet the following Requirements: [ideal requirements] 

1.  Protect the preparation from environmental conditions. 
2. Non-reactive with the product and so does not alter the identity of the product 
3.  Does not impart tastes or odors to the product 
4.  Nontoxic 
5.  FDA approved 
6. Protect the dosage form from damage or breakage 
7. Meet tamper-resistance requirements, wherever applicable. 
8. Adaptable to commonly employed high-speed packaging equipments.

Criteria for the Selection of package type and package material: 

1. Stability 
2.  Compatibility with the contents 
3. Strength of container and the degree of protection required 
4.  Moisture-proofness 
5.  Resistance to corrosion by Acids or Alkalis 
6.  Resistance to grease 
7. Protection against salt 
8.  Resistance to microorganisms 
9.  Resistance to insects and rodents 
10. Resistance to differences in temperature 
11. Protection against light, fire and pilferage
12.  Odor retention and transmission 
13.  Aesthetic effect 
14. Cost 
15. Machine suitability of packaging and the filling method.

Possible Interactions between primary packaging materials and the included pharmaceutical product:

1. The release of chemicals from components of the packaging materials 
2. The release of visible and/or sub visible particles 
3.  The absorption or adsorption of pharmaceutical components by the packaging materials 
4.  Chemical reactions between pharmaceutical product & the packaging materials 
5. The degradation of packaging components in contact with the pharmaceutical products
6.  The influence of the manufacturing process (e.g. sterilization) on the container.

Packaging materials & closures: 

•  Glass 
• Plastic 
• Metals 
•  Paper and Board 
•  Rubber 
•  Cotton 
• Adhesives and Inks 
• Closures

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
6. 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

• Mainly made up of

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.

TYPES OF GLASS

 

Type I – Borosilicate Glass 

Type II – Treated Soda-Lime Glass

 Type III – Regular Soda-Lime Glass 

Type NP – General Purpose Soda-Lime Glass

Coming Soon...........