Chapter 1 PPT 3
Chapter 1 PPT 3
Chapter 1 PPT 3
I) Glass
II) Metals
III) Rubbers
IV) Plastics
V) Fibrous material
ADVANTAGES
• They are hygienic and suitable for sterilization
• They are relatively non reactive ( depending on the grade
chosen)
• They can be used on high speed packaging lines
• They can be easily labeled.
• They are transparent.
• They are available in various shapes and sizes.
• They can withstand the variation in temperature and
pressure during sterilization.
• They are economical and easily available.
• They can protect the photosensitive medicaments from light
during their storage.
• They are neutral after proper treatment.
• They are impermeable to atmospheric gases and moisture.
• They have good protection power.
• They do not deteriorate with age.
• They can be sealed hermetically or by removable closures.
DISADVANTAGES
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation.
• They may crack when subjected to sudden changes of
temperature.
• Some containers can impart alkalinity and insoluble flakes to
the formulations.
Flaking
• During flaking the alkali is extracted from the surface of the
glass containers and a silica rich layer is formed which
sometimes gets detached from the surface and can be seen
in the contents in the form of
shining flakes.
Weathering
Weathering is a common problem with glass
containers in which sometimes moisture
condensed on the surface of glass
container, can extract some weakly
bonded alkali, leaving behind a white
deposit of alkali carbonate.
TYPES OF GLASS:
• Type I ( Neutral or Borosilicate Glass)
• Type II ( Treated Soda-lime glass)
• Type III ( Soda-lime glass)
• NP—soda glass (non parenteral usage)
• Colored glass
• Neutral glass
MINIMUM
TYPE OF
QUALITY OF
PACKAGE TYPE FORMULATION
GLASS THAT CAN
CAN BE PACKED
BE USED
Aqueous Injectables Of Any Type I
pH
Aqueous Injectables Of pH
Type II
Less Than 7
Vial
High density poly ethylene (HDPE) is less permeable to gases and more
resistant to oils, chemicals and solvents.
It is widely used in bottles for solid dosage forms.
POLYVINYLCHLORIDE (PVC):-
Used as rigid packaging material and main component of intravenous
bags.
POLY PROPYLENE:-
It has good resistance to cracking when flexed. Suitable for use in
closures , tablet containers and intravenous bottles.
POLYSTYRENE:-
. It is also used for jars for ointments and creams with low water content.
FIBROUS MATERIALS
The fibrous materials are the important part of pharmaceutical
packaging.
Fibrous materials include: Papers, Labels, Cartons, Bags, Outers,
Trays For Shrink Wraps, Layer Boards On Pallets, etc.
The Applications as well as Advantages of Cartons include:
Increases display area
Provides better stacking for display of stock items
Assembles leaflets
Provides physical protection especially to items like metal
collapsible tubes.
Fiberboard outers either as solid or corrugated board also find
substantial application for bulk shipments.
Regenerated cellulose film, trade names Cellophane &
Rayophane, is used for either individual cartons or to assemble
a no. of cartons.
CLOSURES
Closures are the devices by means of which containers can be
opened and closed. Proper closing of the container is necessary
because
– It prevents loss of material by spilling or volatilization.
– It avoids contamination of the product from dirt,
microorganisms or insects.
– It prevents deterioration of the product from the effect of the
environment such as moisture , oxygen or carbon dioxide.
Categories of Rubbers:
Butyl rubber
Nitrile rubber
Chloroprene rubbers
Silicon rubbers
SYMBOLS USED ON PACKAGES
AND LABELS
Many types of symbols for package labeling are nationally
and internationally standardized. For product certifications,
trademarks, proof of purchase, etc. identification code .
Fragile This way up Keep away from sunlight Keep away from water
Unit Dose packaging
• Blister Packing: In blister packing the unit dosage
forms are enclosed in between transparent blisters and
suitable backing material usually aluminum foil.
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References:-
One of the most difficult aspects of package validation is determining how many
samples to test. The goal is not to over test because of cost considerations while still
running sufficient tests to provide statistically valid sampling. Statistical methods of
analysis are important in process validation. The following decision tree from Medical
Device and Diagnostic Industry, "Streamlining Package-Seal Validation," October
1992, provides various methods of statistical analysis. The manufacturer is challenged
with determining which statistical method is most applicable to their individual needs.
The resulting validation plan should identify, measure, and evaluate the key processes
and variables that will require assessment to complete a validation or revalidation of
the packaging and the packaging process.