Newer trends in parenteral packaging and their advantages over conventional packaging.

1. Submitted by
Abhishek Sunil Dhoot (160603003)
First Year MPharm (Pharmaceutics)
Under the guidance of
Dr. Anup Naha
NEWER TRENDS IN PARENTARALS
PACKAGING
Department of Pharmaceutics
EVALUATORY SEMINAR ON
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2. › Introduction
› Various Packaging materials
– Glass
– Rubber
– Plastic
› Various Container systems
– Ampoules
– Vials
– Cartridges
– Bottles and Bags
– Blow/fill/seal Process
CONTENTS :
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3. • Sterile product packaging systems consist of glass,
rubber, and plastic materials that are in intimate
contact with the formulation.
• There are six basic primary packaging or container
systems:
› 1. Ampoules – glass
› 2. Vials – glass and plastic
› 3. Syringes – glass and plastic
› 4. Cartridges – glass
› 5. Bottles – glass and plastic
› 6. Bags – plastic
• Rubber is used in Closures for vials and bottles,
plunger and seal in syringes etc.
Introduction:
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4. › A Glass is primarily composed of the element
silicon.
› Classification of glass:
– Type I, a borosilicate glass.
– Type II, a soda-lime with a chemical surface
treatment.
– Type III, a soda-lime glass.
– Type IV NP, a soda-lime glass not suitable for
containers for Parenterals
Glass:
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5. 5

6. › In the injectable drug product business, rubber is
used for many applications –
• Closures for vials and bottles
• Seals and plungers for syringes and cartridges,
• Gaskets in manufacturing equipment
› Advances in rubber closure technologies have
introduced closures with special polymer coating
or laminate
Rubber:
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7. › Advancement with the Flurotec® coating is a stopper called
LyoTec™.
› The top surface of the LyoTec™ stopper is treated with Flurotec®.
This prevents the stopper from sticking to the top pressure plates
of the freeze dryer shelves and either coming completely off of the
vial or having the stopper plus the vial stick to the shelf above
› The Flurotec® is a barrier laminate protecting the drug product
from the rubber formulation.
Flurotec treated surface
LAMINATED AREA
SEALED AREA
sealed area
L Laminated area
Advancement with the Flurotec® coating
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8. › Plastics are widely used for parenteral drug
containers and administration devices.
› Thermoplastics are polymers that soften upon
heating and solidify upon cooling with these
processes being reversible.
› Most parenteral packaging are thermoplastics
Plastic:
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9. › Glass sealed ampoules were the most popular
primary packaging system for small volume
injectable products.
› Glass ampoules are Type I tubing glass in sizes
ranging from 1–50 ML
› Major Disadvantage with the ampoules is the
problem of glass particles entering the
solution when the ampoule is broken to
remove the drug product.
Ampoules :
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10. › SafeBreaK™ is a safety ampoule breaker and it
avoids dangerous glass filing required during
breaking the ampoule.
› No gauze pads necessary to protect hands.
› SafeBreaK™ prevents cross contamination
Safety ampoule breaker:
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11. › The most common packaging for liquid and
freeze-dried injectables is the glass vial.
› Plastic is also used
› Plastic vials are made of cyclic olefin copolymer
(COC).
› The appearance of a plastic vial looks identical to
a glass vial.
Vials:
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12. › Syringes are very popular delivery systems
they are used either as empty sterile
container systems where solutions are
withdrawn from vials into the empty syringe
prior to injection.
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13. › In cartridges the drug product is filled into a glass
tube.
› Cartridges are inserted into delivery pens.
› Cartridge/pen delivery systems are used primarily
for multiple dose proteins such as insulin and
growth hormone
Cartridges:
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14. › Bottles and bags typically refer to containers
larger than 100 ML.
› Large volume injectable solutions or emulsions
are contained in bottles or bags rather than vials
› Bottles can be glass or plastic
› Polyvinyl chloride (PVC) was the polymer material
of choice for many years for bags
Bottles and bags:
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15. BLOW/FILL/SEAL Process:
› Aseptic blow-fill-seal (BFS) technology is
the process by which plastic containers are
formed, filled with sterile filtered product
and sealed in an uninterrupted sequence
of operations within the controlled sterile
environment of a single machine.
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› Sterility is very important in parenteral
formulation and Packaging system plays very
crucial role in it . Its keeps the drug safe and
sterile from contamination and protects from
environmental conditions.
Conclusion

17. › Sacha G A, Clemmer W, Abram K. Practical
fundamentals of glass, rubber, and plastic sterile
packaging systems. Pharmaceutical Development
and Technology . 2010 February; 15(1): 6–34
› Zadbuke N, Shahi S, Gulecha B, Padalkar A, and
Thube M. Recent trends and future of
pharmaceutical packaging technology. J Pharm
Bioallied Sci. 2013 Apr-Jun; 5(2): 98–110 Available
from www.ncbi.nlm.nih.gov
› Blow fill seal process. Catalant; 2012 August 29.
Available from
www.youtube.com/watch?v=bw6vMQ7jDHE
References:
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18. THANK
YOU!
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