The document discusses prefilled syringes. It describes prefilled syringes as single-dose packets of injectable drugs that have a pre-attached needle. It discusses the purpose of prefills for primary packaging and drug delivery. It also outlines the types of prefill systems using glass or plastic, describes common materials used, and the filling and sterilization processes. The document provides advantages like convenience and accuracy as well as some disadvantages. It also discusses factors driving the growth of prefilled syringes.

1. PREFILLED SYRINGES
Under the Guidance of
Abdul Mohd. Bari
Associate professor
BY
SRIKANTH BANDI,
H.T.NO :11H61S0303,
DEPARTMENT :PHARMACEUTICS,
SCHOOL OF PHARMACY,
6/14/2012 ANURAGSCHOOL OF PHARMACY
GROUP OF INSTITUTIONS 1

2. CONTENTS:
What are prefilled syringes?
Pupose of prefills
Types of PFS systems
Materials used for the preparation of PFS
Filling process in PFS
Sterilization of prefilled syringes
Steps to use prefilled syringes
Advantages & Disadvantages
Factors Responsible for Growth of Prefilled Syringes
Marketed Products
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conclusion

3. What are prefilled
syringes?
 A prefilled syringe is a single-dose packet of parental
drug to which a needle has been fixed by the
manufacturer.
 Prefillable syringes have become an increasingly
important option in the packaging and delivery of
injectable drug products.
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4. PuRpose of prefills
The prefilled syringe provides two major purposes to
the administration of a drug.
 The first is primary packaging. The purpose of the
primary package is to assure that there is no adverse
effect on the identity, strength, quality, purity or
potency of the drug over its shelf life.
 Second, a prefillable syringe is a delivery system
designed to administer the appropriate amount of the
medicament to the patient.
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5. Types of PSF systems
There are two major types of prefillable syringe
systems available:
 Glass-based systems
 Plastic-based systems
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6. Glass-based systems
 Traditionally, a prefillable syringe barrel has been
made from glass tubing.
 These glass tubes are transformed by heat into the
barrel that is used to hold the drug product.
 Syringe manufacturers typically form and process
the glass and purchase the complementing
elastomeric components (e.g., plungers, tip caps,
needle shields) that complete the primary package
from an elastomeric closure manufacturer.
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7. The benefits of glass systems include:
 Health care practitioners’ long history of
familiarity with the product
 The majority of prefilled syringes in the marketplace,
are glass with elastomeric components
 There are multiple proven suppliers
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8. Drawbacks:
 Breakage
 Dimensional variation
 Potential surface reactivity
 Particulate contamination
 Adhesive or other potential leachables
 Inconsistent application of silicone oil (added for
functionality)
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9. Glass prefilled syringes
are of two types
Oil siliconised syringes:
In this type of prefilled syringe system there is
direct contact of rubber to glass surface leads overtime
to higher break out forces and leads to chances of
contamination.
Baked on silicone syringes:
In this baked on silicone syringes provide
consistent coating of the glass barrel Wales.
Break out forces stay low during storage
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10. 6/14/2012 SCHOOL OF PHARMACY 10

11. pH shift in glass syringes
 The shift in pH occurs because of use of type I glass
used in prefilled syringes manufacturing is a
borosilicate glass.
 Around the beginning of cooling phase at 580 c,
sodium oxide is forms and remains in glass.
 During storage, sodium ions are released into the
water for injection and increase the concentration of
hydroxide ions, thus increasing alkalinity.
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 This causes change in pH in syringes.
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12. pH shift in glass syringes:
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13. PLASTIC-BASED SYSTEMS
Plastic-based syringe systems are gaining
acceptance because of their benefits compared
to glass systems.
The Japanese market, which is well known for its high
quality, has transitioned over 50% of its syringes to
plastic because of its superior performance.
The most widely used prefillable plastic syringe
systems are manufactured from cyclopoly olefin
(COP) resin.
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14. Benefits of plastic-based systems include:
Break resistance
Design flexibility
Decreased surface reactivity
Less absorption/adsorption of the drug
Compatible with high or low pH
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15. Plastics materials used for prefilled
syringes are mainly of two types.
Cyclo olefin polymer (cop)
Cyclo olefin co polymer (coc)
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16. Cyclo olefin polymer (cop) major properties:
Low water absorbency
High transparency
Low specific gravity
High heat resistance
Low impurities
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17. Cyclo olefin co polymer (coc) major properties:
clear amorphous copolymers based on cyclic and
linear olefins.
These materials form a family of engineering resins
that exhibit a unique combination of properties,
including high transparency, low density, excellent
moisture barrier capabilities, and resistance to
aqueous and polar organic media.
Topas® COC is being used for pre-filled syringes,
needleless injectors and other drug delivery systems.
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18. Materials used for the preparation
of PFS:
components composition
Barrel Glass/plastic
Piston Elastomer
Tip cap Elastomer
Plunger Plastic
Lubricant Silicone oil
Needle Stainless steel
Needle Elastomer
Needle shield cover Plastic
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Finger grip extender
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Plastic 18

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20. Filling process in
PREFILLED SYRINGES:
 Newer technique developed by HCM's (Hyaluron Contract
manufacturing) patented method of syringe filling involves
vacuum filling coupled with online vacuum stoppering, Known
as bubble-free filling.
 It eliminates the air bubble inside the syringe, (known as "head
space"), that results from traditionally filling methods.
 Furthermore, totally removing the gas bubble improves the
stability of oxygen sensitive compounds.
 In bubble-free filling, a vacuum (or, more accurately,
differential pressure) is used to place the stopper.
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21. Sterilization of prefilled
syringes
 Sterilization of prefilled syringe is mainly done by autoclaving
or by ionizing radiation.
 Autoclave is not suitable of glass prefilled syringes and normal
plastics, as there occurs a pH shift in glass syringes during
autoclave sterilization process.
 Mainly used method of sterilization is ionizing radiations.
 Gamma sterilization has proved to be an efficient means of
sterilizing prefilled syringes.
 Ionizing radiation has the advantage of sterilization the syringe
plungers while they remain in their packaging.
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22. Steps to use prefilled
syringes
Step 1: Verify the label on prefilled syringe as it may be serious if
wrongly injected.
Step 2: Take out the syringe cap and needle cap without touching
the needle tip to prevent the contamination of the syringe.
Step 3: Insert the needle. Manually inserting a needle into skin can
be the most challenging element of self injection.
Step 4: Once injection is completed, the patient must dispose the
used syringe.
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23. Advantages &
Disadvantages
The first prefilled syringes were made of polypropylene.
The advantages of prefilled syringes are :
Patient related:
 Ease of convenience & use for health care
professionals and patients compared to a traditional
vial packaging system
 Reduced risk of dosage error and contamination
 Greater efficiency
 Improved sterility assurance
6/14/2012  Enhanced product differentiation
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24. Market related:
Reduced therapy and injection
costs
Increased market preference
20% API savings vs. vial filling
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25. A
D
V
A
N
T
A
G
E
S
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26. Disadvantages:
These are complex medical devices
Needle stick injuries
Additional protection required
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27. Factors Responsible for
Growth of Prefilled
Syringes
• Ease of administration,
• more convenient for healthcare professionals and patients,
• easier for home use,
• easier in emerging situations,
• reduction of medication errors,
• better dose accuracy,
• increase assurance of sterility,
• Better use of controlled drugs such as narcotics,
• lower injection cost by less preparation,
• easy storage and disposal,
6/14/2012 • product differentiation.
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28. Marketed products:
1)KINFERON®
(recombinant interferon product)
Strengths:3,5,6MIU/ml
Indications: Acute & chronic
hepatitis(type-B&C)leukemia,
Malignant melanoma,
Renal cell carcinoma,
Ovary carinoma etc.,
Route: IM,SC,intralesional.
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29. 2) AVONEX® :
(Interferon beta-1a)
Strenght:30mcg
Category:anti viral
Route: IM
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30. List of drug that are used
via prefilled syringes
Ardeparin Hospiral lidocaine 1%w/v
Choriogonadotropin ɑ Lidocaine Hcl 2%
Dalteparin Nadroparin
Enoxaparin sodium Reviparin
Diclofenac sodium Sodium hyaluronate 1%w/v
vasopressin Tinozaparin
erythromycin amiodarone
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31. Market growth:
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32. E
Q
U
I Fully
P Automatic
M Pre-Filled
E Syringe
N Filling
T mechine
s: Model:
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32

33. E
Q
U
I
P
M
E
N
T
s:
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34. Conclusion:
As there are many advantages of prefilled
syringes like convenience, affordability,
accuracy, sterility, safety, marketing advantages,
manufacturing advantages, and marketing
advantages,prefilled syringes will eventually
replace the conventional type.
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35. Bibliography:
www.pharmatechnologyindex.com
www.visongain.com
www.jpionline.org
www.biopharminternational.com
www.avonex.com
www.ondrugdelivery.com
www.bd.com
www.ec21.com
www.harikrushnatechnopride.tradeindia.com
www.pharmtech.com
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www.baxterbiopharmasolutions.com
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