This document provides an overview of prefilled syringes, including what they are, their purpose, types, materials, filling and sterilization processes, advantages and disadvantages, and some examples of marketed products. Prefill syringes are single-dose packages containing a parental drug and fixed needle provided by the manufacturer. They serve the purposes of primary packaging and a delivery system to administer the correct dose to patients. The two main types are glass-based and plastic-based systems, with plastic gaining acceptance for benefits like break resistance and decreased reactivity. Proper filling and sterilization processes are important to ensure safety and efficacy.

1. PREFILLED
SYRINGES

2. ✓ What are prefilled syringes?
✓ Purpose 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
CONTENTS…..
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3. ✓ 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.
PREFILLED SYRINGES
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4. ✓ 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.
PURPOSE
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5. ✓ There are two major types of prefillable syringe systems
available:
✓ Glass-based systems
TYPES
✓ Plastic-based systems
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6. ① Glass Barrel/Plastic Barrel : Several sizes are available.
② Luer Lock
③ Finger Grip
④ Plunger
⑤ Piston
⑥Tip Cap
COMPONENTS
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7. ✓ 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.
GLASS BASED SYSTEM
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8. ✓ 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.
BENEFITS OF GLASS SYSTEM
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9. ✓ Breakage
✓ Dimensional variation
✓ Potential surface reactivity
✓ Particulate contamination
✓ Adhesive or other potential leachables
✓ Inconsistent application of silicone oil (added for
functionality)
DRAWBACKS
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10. ✓ 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.
TYPES OF GLASS SYSTEM
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11. TYPES OF GLASS SYSTEM
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12. ✓ The shift in pH occurs because of use of type I glass
(borosilicate glass) used in prefilled syringes manufacturing.
✓ Around the beginning of cooling phase at 5800c, 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.
✓ This causes change in pH in syringes.
PH SHIFT IN GLASS SYRINGES
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13. PH SHIFT IN GLASS SYRINGES
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14. ✓ 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.
PLASTIC SYSTEM
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15. ✓ Break resistance
✓ Design flexibility
✓ Decreased surface reactivity
✓ Less absorption/adsorption of the drug
✓ Compatible with high or low pH
BENEFITS OF PLASTIC SYSTEM
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16. ✓ Cyclo olefin polymer (COP)
✓ Cyclo olefin co polymer (COC)
TYPES OF PLASTIC SYSTEM
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17. ✓ Major properties:
✓ Low water absorbency
✓ High transparency
✓ Low specific gravity
✓ High heat resistance
✓ Low impurities
COC PLASTIC SYSTEM
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18. ✓ 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
COP PLASTIC SYSTEM
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19. ✓ 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.
FILLING PROCESS IN
PREFILLED SYRINGES
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20. FILLING PROCESS IN
PREFILLED SYRINGES
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21. ✓ 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.
STERILIZATION OF PREFILLED
SYRINGES
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22. ✓ 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.
STEPS TO USE PREFILLED
SYRINGES
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23. ✓ 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
✓ Enhance product differentiation
ADVANTAGES
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24. ✓ Market related:
✓ Reduced therapy and injection costs
✓ Increased market preference
✓ 20% API savings vs. vial filling
ADVANTAGES
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25. ADVANTAGES OF PFS
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26. ✓ These are complex medical devices
✓ Needle stick injuries
✓ Additional protection required
DISADVANTAGES
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27. ✓ KINFERON®: recombinant interferon product
✓ Strengths: 3, 5, 6 MIU/ml
✓ Indications: Acute & chronic
✓ hepatitis(type-B&C)leukemia,
✓ Malignant melanoma,
✓ Renal cell carcinoma,
✓ Ovary carinoma etc.,
✓ Route: IM, SC, intralesional
MARKETED PRODUCTS
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28. ✓ AVONEX® :
✓ (Interferon beta-1a)
✓ Strenght:30mcg
✓ Category: anti-viral
✓ Route: IM
MARKETED PRODUCTS
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29. LIST OF DRUG THAT ARE USED
VIA PREFILLED SYRINGES
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30. QUESTIONS???