Gerresheimer - a leading global partner to the pharma and ... · PDF fileGerresheimer - a...

Gerresheimer - a leading global partner to

the pharma and healthcare industry Pharmtech Moscow November 2015

Bernd Zeiss, Manager Technical Support

International Trends and Usage of Glass Prefilled Syringes -

Gerresheimer RTF®

AGENDA

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

11/30/2015 Presentation Medical Systems 2

Gerresheimer 2014

11/30/2015 3 Presentation Medical Systems

A leading partner for the pharma & healthcare industry

Revenues 2014: EUR 1,290.0 m

International presence: Europe, Americas, Asia

High quality customer base: Global blue chip customers

Employees: about 11,000

Head office: Düsseldorf, Germany

Listing: Frankfurt Stock Exchange

Percentage of revenues by market segment

11/30/2015 Presentation Medical Systems

Global Player with strong regional footprint

4

Revenues

2014:

EUR 1,290m

Latin

America

USA

Asia

Europe

Established markets Pharmerging markets (IMS definition) Others

Regional footprint: More than 40 sites worldwide as of November 30, 2014

Life Science

Research Rainer Beaujean

Primary Packaging Glass Uwe Röhrhoff

Plastics & Devices Andreas Schütte


Our organization with 3 divisions

Management Board

Uwe Röhrhoff (CEO) Andreas Schütte Rainer Beaujean (CFO)


Primary Packaging Glass Division Life Science Research Division Plastics & Devices Division

Strategy & Planning

Communication & Marketing

Human Resources

Legal & Compliance

Business Excellence & Continuous

Improvement

Finance

Controlling

Investor Relations & Creditor Relations

Information Technology

Internal Audit

Mergers & Acquisitions

Key Account Management

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:


The Prefillable Syringe Market

Some key figures

Total PFS market 2015 ~ 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

COP syringes

Biotech applications

Anticoagulants

Vaccines

Cartridges

Pen systems

Autoinjectors

Market Trends in Prefillable Syringes


Addressing current and future needs in biotec, auto-injectors

and home use

10 11/30/2015

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

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 800

Quality Management according to

ISO 9001: 2008

EN ISO 13485: 2012

EN ISO 15378: 2011

DMF Type III

Gerresheimer Bünde GmbH: Facts and figures

12 11/30/2015 Presentation Medical Systems


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

15

Glass barrel production and

Needle assembly

Our manufacturing process – a clear commitment to high quality


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


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

16

Transition to the finger flange

low reject rates at filling line

high precision - fit into auto-injectors

Cone

Production

17

Our manufacturing process – a clear commitment to high quality


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

Products Parenteral packaging for the

pharmaceutical industry


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

21

Baked-on siliconization of syringe barrels


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


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)


Elastomer insert

Contact surface to drug product

Components and accessories - Overview


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


short, 1.5 – 2.25 ml, 3.0 ml)

Colors

Materials (polypropylene,

polystyrene, polycarbonate)

Backstops in different


short - 3,0 ml)

Colors



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

Our services Development

Syringes


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

Gerresheimer Syringe Functionality Study


Syringe type

• Syringe type: 1 ml long / 1 ml short, all with staked-in needle

Siliconization

• Siliconization: Spray (pure oil) / baked-on RTF® (emulsion)

Filling

• Filling: Empty and filled [WFI]

Stioppering

• Stoppering: Vacuum and vent tube setting

Plunger

• Plunger article from 2 manufacturers: diff. rubber formulations, designs, coated (and siliconized)/non-coated

Time

• Time: T0, after 3, 6, 12, 24, 36 months, acc. aging at 3 months, 6 months

Effect on

break-loose

and gliding

force?

High quality cartridges

Our products


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


Glas 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.

RTF 4 – latest production equipment

GX3 camera systems – high end controls

Standard and Baked-on siliconization - baked on RTF®

TELC® -Tamper Evident Luerlock Closure

TERNS® -Thermoplastic Elastomer Rigid Needle Shield

Integration into devices like auto-injectors

Why Gerresheimer RTF® syringes?

11/30/2015 To change footer select "INSERT" > "HEADER AND FOOTER" 33

Спасибо Any questions?

контакт

Name Bernd Zeiss, Manager

Technical Support

Gerresheimer

Phone +49 5223 164 309

E-mail [email protected]


Name Bernd Janas

Sales Director

Gerresheimer

Phone +49 5223 164 230


Name Михаил Синицын

Address Россия, Москва, 125212

Ленинградское шоссе, д.25 корп.1

Phone + 7 (495) 287 89 90


Website www.emb-pharma.ru

mailto:[email protected]



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