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International Trends and Usage of Glass
Prefilled Syringes Pharmtech Moscow November 2016
Bernd Zeiss, Manager Technical Support
International Trends and Usage of Glass Prefilled Syringes -
Gerresheimer RTF®
1. Gerresheimer as a Company
2. Prefilled Syringe market
3. Market Trends
4. Why to decide for Gerresheimer
5. Syringe and Cartridge Production in Bünde, Germany
6. Products and Quality
7. Development lab
8. Your questions
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A leading partner for the pharma & healthcare industry
Revenues 2015: EUR 1,377.2m
International presence: Europe, Americas, Asia
High quality customer base: Global blue chip customers
Employees: about 10,700
Head office: Duesseldorf, Germany
Listing: Frankfurt Stock Exchange
Gerresheimer 2015
11/29/2016 Gerresheimer - a leading global partner to the pharma and healthcare industry 3
Percentage of revenues by market segment
11/29/2016 Gerresheimer - a leading global partner to the pharma and healthcare industry
Global player with strong regional footprint
4
Established markets Pharmerging markets (IMS definition) Others
Regional footprint: More than 40 sites worldwide
Revenues
2015:
EUR 1,377m
Latin
America
USA
Asia
Europe
Primary Packaging Glass Uwe Röhrhoff
Plastics & Devices Andreas Schütte
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Gerresheimer Organization
Medical Systems
Medical Plastic Devices
Pharmaceutical: inhalation, injection,
pens, auto injectors
Medical Technology: lancing devices,
lancets, infusion sets, laboratory and
molecular diagnostics, point-of-care
testing, urology, surgery, dialysis and
blood therapy
Medical Systems
Syringes/Cartridges
Gx® bulk syringes (glass)
Gx RTF® syringes (glass)
Syringe components and
accessories
Gx® pen cartridges
ClearJect™ COP syringes
Plastic Packaging
Ophthalmic and rhinologic application
systems
Tablet containers, PET bottles
Special closures
Gerresheimer – Plastics & Devices Division:
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The Prefillable Syringe Market
Some key figures
Total PFS market 2016 > 3,0 Bil. pcs
Markets by size:
1.Eu; 2. USA, 3. China
CAGR 5,5 %
Staked in needle syringes are 2/3 of the market
Needle protection systems (injury prevention)
Low particles
Low tungsten
Reduction of silicone oil
Biotech applications (mAbs against cancer, rheumatoid
arthritis…)
Anticoagulants
Vaccines
Pen systems (cartridge based)
Autoinjectors (prefilled syringes)
COP syringes
Market Trends in Prefillable Syringes
11/29/2016 Presentation Medical Systems 8
Addressing current and future needs in biotec, auto-injectors
and home use
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Tight barrel dimensions
- low dosage adaption (bore, shoulder)
- low residual volume
- exact graduation
Tungsten residuals
- low
- specified
- tungsten free
Rubber parts
- low L&E
- low cosmetic defects
- stoppering method
- gliding force profiles
Silicone oil
- low amounts
- baked-on
- distribution
Glue residuals
- Low
- specified
Needle
- shear forces/viscous drugs
- high inner needle diameter
- Needle protection systems
(safety)
High quality syringe
- low cosmetic defects
Biotech: Higly viscous drugs
Thin wall needles for better delivery
Sensitive protein formulations - low tungsten and low
silicone oil required
Low tungsten specification
Alternative pin materials
Gx Baked-on RTF® syringes
Ophthalmology: Low volume for injection into the eye (intravitreal)
Exact dose mark
Very low particle load (USP requirement)
Gx Baked-on RTF® syringes
Addressing current and future needs in biotec, auto-injectors
and home use
11/29/2016 Presentation Medical Systems 10
Standard Thin wall
Tungsten pin Needle cross section
186
100
24
7
3 months
T0
Gx Baked-on RTF®
Gx RTF® Spray
Particles (free silicone oil)
Home Use with Auto-Injectors
Needs in Biotech, Opthalmology, Home Use II
11/29/2016 Presentation Medical Systems 11
Production site Development and production of primary packaging made
of glass and plastics
Foundation 1947 (Bünder Glas)
Highly automated production running 7 days/24 hours
Production area: 25,700 sqm (277,000 sqft), of that
Clean room class C (acc. GMP): 700 sqm (7,550 sqft)
Clean room class D (acc. GMP): 3,100 sqm (33,400 sqft)
Machinery: > 55 production lines, of that
40 glass forming lines for syringe barrels, insulin cartridges and customized solutions
13 needle mounting lines
4 RTF lines
Employees: about 640
Quality Management according to
ISO 9001: 2008
EN ISO 13485: 2012
EN ISO 15378: 2011
DMF Type III
Gerresheimer Bünde GmbH: Facts and figures
13 11/29/2016 Presentation Medical Systems
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History
2014 2009 2002 1947 1972 1987
Foundation of
Bünder Glas
Production of
tablet tubes,
ampoules and
dental
cartridges
Bünder Glas becomes
part of Gerresheimer
RTF® syringe
production
Bulk prefillable
syringe production
3 RTF® lines
operation
Additional RTF®
line
Production of glass syringes
1Glass barrel production, 2 needle assembly, 3 RTF processing, 4 sterilization
Production
16
Glass barrel production and
Needle assembly
Our manufacturing process – a clear commitment to high quality
11/29/2016 Presentation Medical Systems
Glass
cutting
Barrel
forming
Printing
Cannula
Assembly
100 % in-process control (camera station
for dimensions and cosmetic camera
system)
Quality control
Needle assembly, clean room class D
(acc. GMP)
G3 Vision Technology for 360° product
inspection and strict process control
11/29/2016 Presentation Medical Systems
100 % vision inspection by in-house developed unique camera
systems for dimensional and cosmetics aspects
Vision inspection of the complete syringe barrel surface
Cosmetic controls include differentiation between cracks and
scratches, particles and air lines
tight dimensions
Body Shoulder Finger flange
17
Transition to the finger flange
low reject rates at filling line
high precision - fit into auto-injectors
Cone
Production
18
Our manufacturing process – a clear commitment to high quality
11/29/2016 Presentation Medical Systems
Washing (WFI)
Closure
setting
Nesting/coding
Packaging
RTF processing
Clean room ISO class 7 acc. to class B
under laminar flow
100 % in-process control
Quality control
Siliconization
11/29/2016 Presentation Medical Systems 19
Low cosmetic defects, enhanced cleanliness
constant syringe functionality
optimal processability on filling lines
Products Parenteral packaging for the
pharmaceutical industry
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Pen cartridges
Glass syringes:
bulk
Glass syringes:
ready-to-fill
Gx® bulk
Gx RTF®
Gx® pen cartridges
Our products: Syringes and pen cartridges
Washed, siliconized, pre-
assembled and sterilized
(ethylene oxide)
Cartridges for insulin (glass
type I)
Customized solutions
Fields of application:
Vaccines
Heparins
Biotec drugs
Other applications
Pen cartridges: Insulin
No RTF-treatment
0.5 ml
1.0 ml long
1.0 ml standard
1.5 ml
2.25 ml
3.0 ml
0.5 ml
1.0 ml long
1.0 ml standard
1.5 ml
2.25 ml
Luer lock Luer cone Staked-in needle
Gx RTF® syringes (ready-to-fill): Syringe formats
1.0 ml long
1.0 ml standard
1.5 ml
2.25 ml
3.0 ml
Customized syringe formats on request
22
Baked-on siliconization of syringe barrels
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Benefits over standard
siliconization
Minimize the risk of interaction between
silicone oil particles and drug formulation
Drastically reduced amount of subvisible
silicone oil particles (less than 10%)
Masking and inactivating the glass
surface
Long-lasting, chemical inert, evenly
distributed lubricity coating
Very even break loose and gliding force
profile
Provides optimal functionality and
enhanced performance regarding
silicone oil particle emittance over drug
product shelf life
Patented in Europe and USA
Counting of particles > 10 µm
in prefilled syringes filled with
WFI*
Directly after filling (T0), only
7 % of particles are
generated compared to
standard spray siliconization
After 3 months of storage
(T1) particle generation
remains low in baked-on
RTF® syringes (24 % of
reference)
Components and accessories - Overview
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Closures Needle shields
Flexible Needle Shields (FNS)
Rigid Needle Shields (RNS)
Proprietary Thermoplastic
Elastomer Rigid Needle Shield
(Gx TERNS®)
Luer cone closure: Six Rip Tip
Cap
Luer lock closure:
Tip Cap
Gx TELC® (Tamper Evident Luer
lock Closure)
Cannulas
Cannulas in steel-quality according
to AISI 304 in different
Length (½“, ⅝”)
Diameters (23G, 25G, 26G, 27G,
29G)
Grindings (3 bevel, 3 bevel XL V®
bevel)
Customized solutions
Elastomer insert
Contact surface to drug product
Components and accessories - Overview
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Gx® plunger rods Plunger stoppers
Plunger stoppers in different
Sizes (0.5 ml, 1.0 ml long, 1.0 ml
short – 3.0 ml)
Materials (pharmaceutical
elastomers, fluorpolymer coatings
as an option)
Qualities: bulk, ready-to-sterilize,
ready-to-use
From different suppliers
Gx ® backstops
Plunger rods in different
Sizes (0.5 ml, 1.0 ml long, 1.0 ml
short, 1.5 – 2.25 ml, 3.0 ml)
Colors
Materials (polypropylene,
polystyrene, polycarbonate)
Backstops in different
Sizes (0.5 ml, 1.0 ml long, 1.0 ml
short - 3,0 ml)
Colors
Customized solutions
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4
Our quality standards
Our products comply with:
Pharm. Eur., USP, JP
ISO requirements for glass
primary packaging materials
Produced on own-engineered state-
of-the-art glass forming and cannula
assembly lines in accordance to
cGMP
Clean room production class B, C, D
(acc. GMP)
Continuous process improvement
G3 camera system in barrel
production
11/29/2016 Presentation Medical Systems 27
Syringe handling
Preparation equipment
Syringe siliconization
Syringe filling
Vent tube setting
Vacuum setting
Testing machine for tensile and
compression testing (Zwick Roell)
Mounting/removal forces: tip
cap, needle shield, backstop
Breakage: finger flange, cone
UV glue testing
Climate Chamber (temperature,
humidity)
Siliconization analysis
Development Laboratory: Syringe functionality
Production in Europe
Well known and established RTF® packaging
brand
Product range to be extended
Metal oxide free (tungsten free)
Gx RTF® Enhanced - metal free prefillable glass syringe
Baked on siliconized barrel to minimize
subvisible particles (silicone oil) & good
functionality
Fluorpolymer coated
plunger stoppers to further
minimize leachables & silicone
Gx TELC ® :Tamper
evident Luer lock
closure
Full range of
accessories like
rod and backstop
29.11.2016 Presentation Medical Systems
Production in Europe
Well known and established RTF® packaging
brand
Customized COP/COC syringe designs on
request
Metal oxide free
NEW: Gx RTF® ClearJect® - metal free prefillable COP syringe
No glass breakage
Siliconized using high viscous silicone
oil to minimize subvisible particles
(silicone oil) & optimal functionality
Standard fluorpolymer coated
plunger stoppers applicable
Glue free
Gx closures possible
Full range of
accessories like
rod and backstop
29.11.2016 Presentation Medical Systems
High quality cartridges
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Pen Cartridges
Gx® Cartridges
Sizes from 1.5 to 3.0 ml, larger sizes up to 10.0 ml
on request
Visual inspection systems for 100 % dimensional
control
Designs according to DIN ISO 13926-1; customized
formats on request
Customized ceramic printing with heavy-metal-free
inks
Packaging options: PP-box, other options on request
Suited to standard filling and packaging equipment
Drug Master File Type III
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Glass and plastics expert
Products:
Standard and customized
Full Service
in Glass and
Plastics
Materials:
Glass and plastics
Services:
From the first idea to the
finished product
Broad syringe portfolio
High quality
Big variety and many accessories / components
High capacities
Long term experience
Syringe customization – strong development dept.
GX3 camera systems – high end controls
RTF 4 – latest production equipment
Standard siliconization and baked on RTF®
TELC® -Tamper Evident Luerlock Closure
TERNS® -Thermoplastic Elastomer Rigid Needle Shield
Integration into devices like auto-injectors
ClearJect® COP syringes
Why Gerresheimer RTF® syringes?
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Спасибо Any questions?
контакт
Name Bernd Zeiss, Manager
Technical Support
Gerresheimer
Phone +49 5223 164 309
E-mail [email protected]
11/29/2016 34 Presentation Medical Systems
Name Jens Fernis
Sales Director
Gerresheimer
Phone +49 5223 164 230
E-mail [email protected]
Name Михаил Синицын
Address Россия, Москва, 125212
Ленинградское шоссе, д.25 корп.1
Phone + 7 (495) 287 89 90
E-mail [email protected]
Website www.emb-pharma.ru
