What Is The Best Choice of Material For Your Pre-Fillable Syringe

What is the best choice of material for your pre-fillable syringe
Tom Van Ginneken
© SCHOTT AG, What is the best choice of material for your pre-fillable syringe
Agenda
1. PFS Introduction
2. Global PFS Market & Current Issues
3. Advantages and Limitations of Glass and Polymer PFS
4. Case Studies on Selection of Glass or Polymer PFS
5. Summary and Take Away Messages
2
3
Pre-fillable syringe(PFS) is a “Combination Product”
A pre-fillable syringe (PFS) is a device which is used to store & administer

injectable drugs.
Container and injection device in one
3
PFS advantages
 Container and injection device in one

 Easy to use and convenient – for patients (self administration)
and healthcare providers
 Reduce overfill
 Reduce risk of dosage error or contamination
 Increase patient compliance
 Differentiation on the market
 With ready-to-use (RTU) PFS - Flexible and small
manufacturing footprint (fill finish operations)
4
Syringe Market Overview
Global Syringe Market
Disposable syringes Pre-fillable syringes (PFS)

(mostly polypropylene) Drugs are stored in the syringes
Drug is taken out of a container and also administered 95%
5% Polymer PFS Glass PFS
Notes:
COC/COP PFS Polypropylene PFS COC: Cyclic Olefin Copolymer
mostly for diluents COP: Cyclic Olefin Polymer
Japan COP/(PP) Rest of the World COC / (COP)

Source: SCHOTT market analysis
5
Syringe Market Growth
Strong increase in amount of drug Top blockbusters for injectable drugs

approvals with a PFS as packaging differentiate themselves through PFS
6 out of top 20 injectable 9 out of top 20 injectable

24 drugs in 2000 in PFS drugs in 2018
• Epogen • Humira
FDA • Actrapid • Opdivo
• Leuprolelin • Keytruda
EMA
17 •
•
Neoral
Humulin
•
•
Enbrel
Herceptin
• Rocephin • Eylea
• Lovenox • Avastin
• Zoladex • MabThera
• MabThera • Prevnar
9 • Kogenate • Remicade
• Sandostatin • Stelara
6 6 • Humalog • Neulasta
4 3 3 4 3
•
•
Gonal F
Herceptin
•
•
Lantus
Lucentis
1 •
•
NovoSeven
Norditropin
•
•
Victoza
Botox
• Infanrix, Pediarix • Soliris
• Copaxone • Simponi
2000 2005 10 11 12 13 14 15 16 17 18 • Rebif • Trulicity
• Activase • Gardasil
Source: FDA and EMA website Drug names in blue and bold are in PFS configuration
Source: GlobalData
6
PFS Market Segmentation
Vaccine Heparin
30% of the market in 40–45% of the market
Volume Growing Market due in Volume Stable mature
increasing population Market Strong competition
density New Therapeutics with genericers for domestic
Vaccine market
Biologics
Other Applications <10% of the market in
Other category 10-20% of Volume. Fast Growing Market
the market Possible sub- (double digit growth Large field
segment: Ophtalmic, Diluent of therapeutic class (Orphan
Accute Care, … disease, Inflamatory Disease,
Growth Hormone, …)
7
Focus topics for PFS currently in Industry
Patient safety, easy & Processing – no issues Drug stability – avoid

Material choice - Glass
convenient drug in fill & finish drug-container
vs. Polymer
delivery operations interaction
Quality, compliance and cost
8
FAQ – What is better? Glass or Polymer PFS?
The Answer:
“It Depends!”
Glass PFS Polymer PFS
OR
„Glass is still the preferred „Polymer solves all the PFS

material for PFS…“ problems“
The right question should be

What is the customer´s need or the intended use?”
9
Intended use has a major influence in selection of PFS
Route of Factors:
admin- Patient
-istration Competitors
Drug formulation
Drug delivery d
Injection devices
Patient Healthcare Fill and Finish
frequency
- Dexterity of patients reimburse- Market
Drug ment
- Age
delivery
- Sex
devices - BMI Time to
(DDD) - Genetic makeup market
Type of - Geography Fill and Finish
- End user preference
Injection
- Production
- Supply Chain
User
- Quality attributes
Preference Viscosity - Transport and Drug price
Place of storage
Human drug
Factors administrati
on
10
Glass versus Polymer
▪ Known material ▪ Flexibility in design
▪ Barrier properties (H2O; O2) ▪ Siliconization (low / no)
ADVANTAGES
▪ Compatible with multiple fill machine ▪ No Tungsten / No adhesive

vendors ▪ Less breakage
▪ Known regulatory path ▪ Sterilization (Gamma, x-ray, e-beam)
▪ Standardized systems including rubbers ▪ Absence of heavy metal
▪ Multiple suppliers for syringes and raw ▪ Design space for branding
material ▪ Product pH constant over time
▪ Glass like transparency
▪ Breakage
▪
LIMITATIONS
Semi-permeable (oxygen, gases)

▪ More weight
▪ More scratch sensitive
▪ No gamma, e-beam possible
▪ Not suitable for oily substances
▪ Heavy Metal Ion release
▪ Often no multiple supply source
▪ Sodium Leaching
▪ Discoloration by irradiaton
▪ Tungsten Pins
▪ Market acceptance for the material
▪ Adhesive for needle bonding
11
Case Study 1: PFS for Heparin
G/P G/P
Staked needle syringe

Drug stability
for self administration
G G/P
Graduation on barrel Functionality
G G
Safety devices /
Multiple suppliers
integrated safety
G G
Regulatory pathway Filling process
P Polymer PFS offers advantage G Glass PFS offers advantage G/P No clear advantage glass vs. polymer
12
Case Study 2: PFS for Vaccines
G/P G
Luer Lock syringe or
Drug Stability or SN PFS with 25 G
5/8” or 1” needle
G G/P
Dose mark on barrel Functionality
G G
Multiple suppliers
Safety devices
(seasonality for Flu
compatibility
vaccine)
G G
Regulatory pathway Filling process
13
Case Study 3: PFS for dermal fillers
P P
Design Flexibility
(customization)
Integrated Luer lock
- Size
- LL pitch design
- Inner diameter
- Finger flange designs
P P
Consistent gliding
Tight tolerances
force
G/P P
Inert material and
barrier Break resistance
(for drug stability)
G/P G
Ready for filling
Low contamination &
process
particles
14
Case Study 4 : PFS + NLADs
P P
Integrated Luer lock
Design Flexibility
- (No LLA Rotation or
- Luer cone dimensions
pop-off or avoid
(large luer diameter)
spontaneous
- Customized designs
disconnections)
P P
NLAD = Needleless Luer Access Devices (IV connectors)
Tight tolerances Break resistance

To reduce the potential risks to patients, FDA
recommends that healthcare professionals and risk
managers stock crash carts, ambulances, and
P G/P emergency rooms with adenosine and amiodarone
supplied in […] pre-filled plastic syringes, if
possible.[…] The use of needleless pre-filled
Regulatory guidance Drug stability glass syringes in emergency situations should
be avoided, if possible. *
*Source: http://www.fda.gov/Drugs/DrugSafety/ucm254215.htm
15
Case Study 5: PFS for Infusion therapy (syringe pumps)
P P
Large size SCHOTT TOPPAC® infuse:
Integrated Luer lock large volume polymer PFS
10, 20 and 50ml
P P
Consistent gliding
Well-defined geometry
force
and tight tolerances
(No stick-slip effect)
G P
Inert material and Syringe pumps ideal solution
barrier Break resistance
for IV
(for drug stability)
G/P G/P
ISO 7886-2
Low contamination &
ISO 11040
particles
IEC 60601-2-24
G/P P
Ready for filling Compatibility tests:
process PFS + pump +
software
16
Case Study 6: PFS for Biotech drugs
G/P
Drug stability
- Low/ no tungsten
- Low leachables
Source: http://www.shl-group.com/images/announcements/molly-dai-sdi-mix.jpg
- Barrier
G/P P
Use in Autoinjectors
Staked needle syringe - Dimensions
- Breakage
G G/P
Multiple suppliers Functionality
G G
Ready for filling
Regulatory pathway
process
17
FAQ – What is better? Glass or Polymer PFS?
OR
The Answer:
“It Depends!”
18
Understanding customer/user needs is crucial
Drug Regulatory Commercial Life cycle

development approval manufacturing management
Product Process Patient/User

▪ Drug stability ▪ Total Cost of Ownership ▪ Human Factors
▪ Silicone ▪ Visual inspection (Cosmetic ▪ Integration with Device
Defects) (Safety, Auto-Injectors…)
▪ Tungsten
▪ Processability ▪ Gliding force
▪ Adhesive
▪ Security of supply ▪ Dimensions
▪ Rubber
▪ Sterilization ▪ Breakage
▪ Surface prop.
▪ Shape / Design
▪ Permeability
▪ Ease of use
▪ E&L
19
SCHOTT can help choosing the right PFS for you unbiased
towards material
Glass PFS - syriQ® Polymer PFS – SCHOTT TOPPAC®

▪ Product range 0.5 to 3 ml with 4 different closures ▪ Nested syringes in sizes 1 to 50 ml
▪ Made of SCHOTT Fiolax® type 1 tubing – easy switch

from vial to PFS
▪ Made of high tech polymer, cyclic olefin copolymer (COC), Topas®
▪ Packed in nest and tub, ETO sterilized and ready for filling ▪ Packed for ‘ready to use’ and sterilized by Gamma irradiation
▪ Glass syringe barrels also available in bulk ▪ More than 40 products in COC syringes approved and
commercially sold worldwide
20
Take away Message
 Glass is still the preferred material used for PFS but polymer COC
syringes are a great alternative with own benefits
 Many suppliers for both glass and polymer PFS – choosing the
right partner is vital for success
 Current Industry issues for PFS – Drug-container interaction, user
interaction, processing of PFS, quality and regulatory compliance
 Both glass and polymer have advantages and disadvantages -
Understanding customer needs is crucial to offer the right solution
 SCHOTT your global partner for both glass and polymer PFS
solutions with unbiased support
21
For more information contact:
Tom Van Ginneken
Global Product Manager – SCHOTT TOPPAC®
SCHOTT Pharmaceutical Systems
Tom.van-ginneken@schott.com

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What Is The Best Choice of Material For Your Pre-Fillable Syringe

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What is the best choice of material for your pre-fillable syringe

Tom Van Ginneken

2. Global PFS Market & Current Issues

3. Advantages and Limitations of Glass and Polymer PFS

4. Case Studies on Selection of Glass or Polymer PFS

5. Summary and Take Away Messages

Pre-fillable syringe(PFS) is a “Combination Product”

A pre-fillable syringe (PFS) is a device which is used to store & administer

Container and injection device in one

 Container and injection device in one

Disposable syringes Pre-fillable syringes (PFS)

5% Polymer PFS Glass PFS

Japan COP/(PP) Rest of the World COC / (COP)

Strong increase in amount of drug Top blockbusters for injectable drugs

6 out of top 20 injectable 9 out of top 20 injectable

Patient safety, easy & Processing – no issues Drug stability – avoid

Quality, compliance and cost

„Glass is still the preferred „Polymer solves all the PFS

The right question should be

▪ Compatible with multiple fill machine ▪ No Tungsten / No adhesive

Semi-permeable (oxygen, gases)

Staked needle syringe

Graduation on barrel Functionality

Regulatory pathway Filling process

Dose mark on barrel Functionality

Regulatory pathway Filling process

Tight tolerances Break resistance

Multiple suppliers Functionality

Glass PFS Polymer PFS

Drug Regulatory Commercial Life cycle

Product Process Patient/User

Glass PFS - syriQ® Polymer PFS – SCHOTT TOPPAC®

▪ Made of SCHOTT Fiolax® type 1 tubing – easy switch

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