Type, Properties and Application of Blister Packaging for Pharmaceutical Product

Film for blister packaging is requiring compliance with shelf-life standards and protection from gas, moisture, chemicals, and extraneous microbiological and particulate contamination. The ability to precisely control film specifications for blister packaging enables this technique to be used to make specialized products such as child-resistant packaging. The technology for creating child-resistant packaging involves using seals, custom plastic banding, and container closures that must be pressed, twisted, or mechanically manipulated for entry. Foil webs require push-through or puncture to gain entry, and complete plastic tubes are used to totally enclose a package. Medical applications of blister packaging include surgical instruments, medical pouches, implantable devices, diagnostic test kits, and disposables.

Blister Packaging Components and Materials for Pharmaceutical Product (Part IV : Printing inks)

The purpose of printing inks in blister packaging is provide graphics and aesthetic appeal. They can be applied to the lidding material by letterpress, gravure, off-set, flexographic, or silk-screen printing processes.

Printing inks requirements for blister packaginf:
  • resist heat- sealing temperatures as high as 300 8C without showing any discoloration or tackiness (blocking).
  • resist abrasion, bending, and fading
  • safe for use with the intended product
  • should not contain excessive amounts of hydrocarbon lubricants, greases, oils, or release agents.
Cold-formed foil/foil
Best known blister package is made from foil, film, paper, or multimaterial backing that is adhered to a sheet of thermoformed plastic blisters. However, a less common type of blister is the foil/foil lamination used for products that are particularly susceptible to moisture and/or light. Unlike all-plastic blisters, these are not thermoformed but instead are cold-pressed into shape. Products that require the highest degree of protection are packed in an all-foil package. Cold-formable foil is finding favor because it is the only material that provides a 100% barrier to moisture, oxygen, and light. This has helped expand the applications in which blisters can be used, allowing the blister packaging of sensitive products.

Blister Packaging Components and Materials for Pharmaceutical Product (Part III : Heat-seal coatings)

The heat-seal coating influence the appearance and physical integrity of the package. Heat-seal coatings provide a bond between the plastic blister and the printed lidding material. These solvent or water based coatings can be applied to rolls or sheets of printed paperboard using roll coaters, gravure or flexographic methods, knives, silk-screening, or sprays. It is essential that the proper coating weight be applied to the lidding material for optimum heat-sealing results.


Blister Packaging Components and Materials for Pharmaceutical Product (Part II :Lidding Materials)

Lidding materials
The lidding material act as the base or main structural component upon which the final blister package is built. Selection for lidding material should consider the size, shape, weight of the product, and the style of the package to be produced. Lidding materials range in caliper or thickness from 0.36 to 0.76 mm (0.46–0.61 mm is the most popular range). The surface of the lidding material must be compatible with the heat-seal coating process. Clay coatings are added to the lidding material to enhance printing.

Lidding material can be clear plastic, but in pharmaceutical packaging it is either plain or printed 1-mil foil (for push-through blister types) or paper/foil or paper/PET/foil laminations (for child-resistant peel–push types). The lidding material must guarantee a WVTR that is at least as low as that of the forming films, and it must be suitable for the type of opening appropriate to the package (e.g., push-through or peel-off).

Comparison of Lidding Material
Lidding Material Price per Unit Area Weight*
0.8-mil Aluminum, hard, push-through601
0.8-mil Aluminum, hard, heat seal-coated, side-printed, push through611.25
1-mil Aluminum, soft, child resistant761.15
45 g(m-2)/1-mil Paper/aluminum, peel-off1211.55
45 g(m-2)/0.48-mil Paper/PET/aluminum, peel off-push through1422.00

*Where 1 represents the price per unit area of 0.8-mil, hard, push-through aluminum

Types of lidding materials.

There are several type of lidding material :
1. Hard aluminum
2. Soft aluminum
3. Paper/aluminum
4. Paper/PET/aluminum

Blister Packaging Components and Materials for Pharmaceutical Product (Part I : Forming Film)

The four basic components of pharmaceutical blister packages are :
  1. the forming film (80–85% of the blister package)
  2. the lidding material (15–20% of the total weight of the package)
  3. the heat-seal coating
  4. the printing ink

The forming film and the lidding material form an integrated package, they must match precisely.

Forming film
The forming film is the packaging component that receives the product in deep drawn pockets. Thing should be consider in selecting plastic film for the blisters are the type, grade, thickness, height and weight of the product, sharp or pointed edges of the final package, and the impact resistance, aging, migration, and cost of the film. The plastic also must be compatible with the product. Factors influencing package production and speed of assembly must be taken into account, including heat- sealing properties and the ease of cutting and trimming formed blisters.

Plastic forming films such as PVC, polypropylene (PP), and polyester (PET) can be thermoformed, but support materials containing aluminum are cold-formed. The forming film usually is colorless and transparent, but it can be obscured for use in child resistant packages or to protect light-sensitive drugs. The forming web for blister packs nearly always is PVC, sometimes coated or laminated with additional components that enhance the oxygen and water-vapor barrier.

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