High-Quality Pharmaceutical Plastic Packaging and · PDF fileHigh-Quality Pharmaceutical...

www.gerresheimer.com

High-Quality Pharmaceutical Plastic Packaging and Systemsfor Ophthalmic, Nasal and Parenteral Applications

Gerresheimer is an internationally leading manufacturer of high-quality specialty products made of glass and plastic for the global pharma and healthcare industry. Our comprehensive portfolio of products extends from pharmaceutical vials to complex drug deliv-ery systems such as syringe systems, insulin pens and inhalers for safe medication dosage and application. Together with our part-ners, we develop solutions which set standards and have role mod-el status in their respective market sectors.

Gerresheimer Plastic Packaging

About GerresheimerOur Group realizes revenues of around one billion euros and has about 11,000 employees at 47 locations in Europe, North and South America and Asia. We use first-rate technologies, convinc-ing innovations and targeted investments to systematically con-solidate our strong market position.

Europe

Gerresheimer Vaerloese | Denmark Gerresheimer Haarby | DenmarkGerresheimer Boleslawiec | PolandGerresheimer Valencia | SpainGerresheimer Zaragoza | Spain

Asia

Gerresheimer New Delhi | IndiaGerresheimer Kundli | India

South America

Gerresheimer São Paulo, Butanta | BrazilGerresheimer São Paulo, Cotia | BrazilGerresheimer São Paulo, Embu | BrazilGerresheimer Buenos Aires | Argentina

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Solid

Gerresheimer Plastic Packaging SolutionsIntelligent products for diverse pharmaceutical applications

Ophthalmic, Nasal and Parenteral Applications

PET / Liquid & Solid

Gerresheimer Plastic Packaging specializes in the widely varied spectrum of pharmaceutical plastic packaging within solid, PET and ophthalmic applications, plastic vials and plastic bottles for personal care. Our leading brands Duma®, Dudek™ and Triveni for solid dosage, edp-branded PET bottles for liquid dosage and our ophthalmic products form part of a comprehensive and innovative product range. Our plastic vials branded MultiShell® are specially designed for sensitive parenteral drug formulations.

Our standard range includes a wide choice of different types of containers and closures, PET bottles, eye droppers, nasal sprays, nebulisers as well as numerous customized developments.

Using our ideas and experience to produce intelligent, increasingly safe and user-friendly packaging solutions has enabled us to be-come an innovative partner to the global pharmaceutical industry.

We know, understand and reinforce our customers business.

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Specialist and quality leader in primary plastic packaging

Strong regulatory approach

· Solution providing

· Good Manufacturing Practice (GMP)

· ISO certifications (ISO 9001, ISO 15378, ISO 14001)

· High level of documentation and registration

· Standard product database

· FDA and world-wide registration of all products

Our manufacturing operations use state-of-the-art technology and apply the most rigorous quality and hygiene standards. They cover all production technologies from injection moulding and injection blow moulding to blow moulding processes. The majority of our production operations are carried out in modern classified clean-rooms or in clean conditions. All plants apply the rules of Good Manufacturing Practice (GMP) and are certified in accordance with ISO standards.

We ensure full conformity of our products with the European Pharmacopoeia, the United States Pharmacopeia and the requirements for FDA registration with a Drug Master File as the standard. Knowing the extensive requirements of our customers we focus on providing a high level of documentation with our products.

· Automated in-line controls

· Vision-based inspection system

· Class 7 (10,000) + class 8 (100,000) clean-rooms

· US and Canada Drug Master File

· Product registrations in Russia, China and the Ukraine

· Food approval

Strong quality cultureA strong quality culture supports our efforts to deliver excellent quality. The culture is defined by our shared beliefs, values and behaviour patterns.

· Quality attitude and team work

· Continous improvements

· Systematic problem solving

· Quality by design

· Stable, robust, reliable and validated processes

· Risk-based approach

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Duma® OneLiner®

Do you believe that standardizing packaging and closure solutions for the international pharma markets is a good idea? Our optional liner for the otherwise identical Duma® Twist-Off containers is one such solution – and it’s a worldwide first.

In future you will be able to use the same container and closure type on your filling lines in both the USA and Europe. The only dif-ference is the liner inside the closure. It has the necessary foil seal for the US market, is manufactured in top quality and complies with all the relevant pharmaceutical regulations. That’s what we call efficiency.

· Hygienic seal· TE function· Stability / shelf life extension· Reseal after opening

MultiShell® plastic vials

Gerresheimer`s MultiShell® vials unite the best properties of plastic and glass in a new high performance packaging for liquid medica-tions.

MultiShell® vials have a unique triple-layer structure consisting of a layer of polyamide sandwiched between two Cyclic Olefin Polymer layers. They have unique barrier properties which enhance the drug stability over shelf life. The extraordinary puncture-resistance of the multilayer structure prevents the liquid leaking, even when un-usual forces are applied, and predestines MultiShell® vials as pack-aging of cytotoxic drug solutions.

Gerresheimer has established commercial production line and offer now 2, 5, 10, 15, 50 and 100 ml vials. The installation of a multi-functional, automated packaging line will enable the packaging of different vial finish from standard to ready-to-use.

· Unique barrier performance· Superior break resistance· Low adsorption· No metal ions· Inert against high and low pH· Available in standard, RTS and RTU

Dedication to technological advancement and product development enable Gerresheimer to set benchmarks in packaging design. We offer our pharmaceutical customers the very latest developments in packaging systems.

Gerresheimer Plastic Packaging’s most recent innovations are the OneLiner® and our parenteral MultiShell® vials.

Innovative and trendsetting

· Longer shelf-life requirements for sensitive pharmaceutical

formulations

· Higher compliance standards

· Child-resistant and senior-friendly closure systems

· Total solution provider

· Barrier packaging

· Unique, customized solutions for niche market segments

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Ophthalmic, nasal and parenteral applications

· Dropper and CLC bottles

· Nasal sprays with nebuliser

· Nasal sprays with pump

· Bottles in LDPE & HDPE

· Bottles in PP

· Droppers in LDPE

· Caps in HDPE & PP

· Large range of bottles & droppers

Our products for ophthalmic and nasal applications include bottles and droppers in LDPE, CLC bottles and nasal sprays with either nebulisers or pumps.

Other materials, sizes and designs are available, as are closures with child-resistant or senior-friendly features.

The innovative design of the high-performance MultiShell® vials is based on a combination of the plastic material COP (Cyclic Olefin Polymer) and a polyamide layer which provides high barrier properties.

· Other materials, sizes and designs

available

· Tamper-evident

· Child-resistant & senior-friendly closures

· MultiShell® vials (standard, RTS and RTU)

· FDA registered, DMF type III,

DMF no. 22946, DMF no. 16117

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Content

Dropper bottles –

System B

Dropper bottles –

System Q

Dropper bottles –

System CL

Dropper bottles – System PR and CT

Spray bottles with nebuliser – System NEB

MultiShell® vials (standard, RTS and RTU)

Spray and pump systems: Snap-on bottles

Accessories

Accessories

7

5

Accessories A1ST9

4

6

8

10

12

14

13

CLC bottles11

3Dropper bottles –

System A

Accessories1

2

OPhthALMic

NASAL

PArENtErAL

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Pharmaceutical Plastic Packaging

Packaging for ophthalmic applications

3

4

6

2

5

7

1

8

9

Dropper bottles –System A (LDPE)

ref ml ml mmmm mm

SPEcificAtiONS

35034 2 3 17 34,5 11 x 2

35036 5 7,5 21 42 14 x 2

35035 10 12,5 24 52 14 x 2

35048 10 12 24 52 14 x 2

35037 15 18,5 25 63 14 x 2

35030 25 28 31 65 14 x 2

35038 30 35 31 75 14 x 2

35080 50 60 39 81 14 x 2

32266 60 68 39 88 14 x 2

32293 115 124 45 107 14 x 2

32295 135 140 45 121 14 x 2

32271 280 314,5 60 148 14 x 2

10

11

12

· Material: LDPE· Available in other materials, sizes and designs

· Radiation or ETO sterilisation on request· Accessories: see page 12 and 13

13

14

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1

3

4

6

2

5

7

8

9

Dropper bottles –System A (HDPE)

10

11

12

· Material: HDPE· Available in other materials, sizes and designs

* Material: PP – Limited availability (further information upon request)

ref ml ml mmmm mm

SPEcificAtiONS

35073* 5 7,5 21 42 14 x 2

35047* 5 7,5 21 42 14 x 2

35046 5 7,5 21 42 14 x 2

35003 10 12,5 24 52 14 x 2

35037 15 18,5 25 63 14 x 2

35041 30 35 25 63 14 x 2

32333 60 62 39 81 14 x 2

32334 65 68 39 88 14 x 2

32331 115 124 45 107 14 x 2

32327 250 301 58 147,5 14 x 2

33067 360 382 58 181 14 x 2

· Radiation or ETO sterilisation on request· Accessories: see page 12 and 13

13

14

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3

4

6

2

5

7

1

8

9

10

11

12

Dropper bottles – System A: Accessories

13

14

Dropper

tamper-evident screw cap

tamper-evident wing screw cap

child-resistanttamper-evident screw cap

Nozzle

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1

3

4

6

2

5

7

8

9

ref

15190

15197

15233

15255

15207

15250

91176

Tamper-evident screw cap

Tamper-evident screw cap for nozzle

Tamper-evident wing screw cap

Child-resistant tamper-evident screw cap

10

11

12

· Material: tamper-evident screw cap HDPE, tamper-evident wing screw cap HDPE, child-resistant tamper-evident screw cap HDPE· Available in other materials, sizes and designs· Caps fit bottle sizes on page 10 and 11

ref Drops/ml +/- 20%

SPEcificAtiONS

14110 21

14166 23

14182 24

14213 22

14214 28

14216 24

14219 14

14180 –

14222 –

Dropper

Nozzle

· Material: dropper LDPE, nozzle LDPE· Available in other materials, sizes and designs· Droppers and nozzles fit bottle sizes on page 10 and 11

13

14

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3

4

6

2

5

7

1

8

9

10

11

12

13

14

Dropper bottles –System B

SPEcificAtiONS

· Material: LDPE· Available in other materials, sizes and designs· Radiation or ETO sterilisation on request· Accessories: see page 15

ref ml ml mmmm mm

38005 5 7,1 19 44 16 x 2

38010 10 14,2 25 53 16 x 2

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1

3

4

6

2

5

7

8

9

10

11

12

13

14

SPEcificAtiONS

ref Drops/ml +/- 20%

15015 –

15016 –

14004 21

14002 18

Tamper-evident

screw cap

Dropper

Dropper bottles –System B: Accessories

· Material: dropper LDPE, tamper-evident screw cap HDPE· Available in other materials, sizes and designs· Droppers and caps fit bottle sizes on page 14

Droppertamper-evidentscrew cap

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3

4

6

2

5

7

1

8

9

10

11

12

13

Dropper bottles – System Q

SPEcificAtiONS

· Material: LDPE· Accessories: see page 17

14

ref ml ml mmmm mm

200 5 9 22 44 Q

201 10 13 22 56 Q

726 15 16 23 65 Q

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1

3

4

6

2

5

7

8

9

10

11

12

13

14

Dropper bottles – System Q: Accessories

SPEcificAtiONS

ref

10054 Q

10055 Q

Dropper

Tamper-evident screw cap

mm

· Material: dropper LDPE, cap PP· Dropper and cap fit bottle sizes on page 16

Dropper tamper-evidentscrew cap

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3

4

6

2

5

7

1

8

9

10

11

12

13

Dropper bottles – System CL

SPEcificAtiONS

141 5 10 25 42 A1ST

142 10 14 25 50 A1ST

143 15 20 25 66 A1ST

528 25 31 31 66 A1ST

144 45 53 31 96 A1ST

195 60 65 35 96 A1ST

059 120 140 42 133 A1ST

· Material: 5 – 45ml bottle LDPE, 60 – 120ml bottle HDPE· Radiation or ETO sterilisation on request · Accessories: see page 19

14

ref ml ml mmmm mm

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1

3

4

6

2

5

7

8

9

10

11

12

13

14

Dropper bottles – System CL: Accessories A1ST

SPEcificAtiONS

ref

10008 A1ST

10005 A1ST

Dropper

Cap

mm

· Material: dropper LDPE, cap PP· Dropper and cap fit bottle sizes on page 18

Dropper cap

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3

4

6

2

5

7

1

8

9

10

11

12

13

Dropper bottles – System PR and CT

SPEcificAtiONS

069* 30 35 31 73 PR

247 15 19 23 73 PR

249 30 35 28 89 PR

· Material: bottle HDPE, dropper LDPE, cap HDPE· Supplied with droppers and tamper-evident bicolour caps· Reference to spray / pump supplier on request

* Available in LDPE

14

ref ml ml mmmm mm

AccESSOriES

ref

10040

01432

Dropper

Tamper-evident bicolour cap

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1

3

4

6

2

5

7

8

9

10

11

12

13

SPEcificAtiONS

14

CLC bottles

058 120 140 41 133 ST2

· Material: bottle HDPE, dropper LDPE, cap HDPE· Supplied with droppers and caps

ref ml ml mmmm mm

AccESSOriES

ref

10039

10034

Dropper

Cap

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Packaging for nasal applications

1

3

4

6

2

5

7

10

11

12

8

9

13

Spray bottles with nebuliser – System NEB

SPEcificAtiONS

138 20 23 31 x 22 68 NEB

139 30 40 39 x 26 77 NEB

· Material: bottle LDPE, nebuliser LDPE, cap HDPE· Supplied with two different nebulisers and tamper-evident bicolour caps 14

ref ml ml mmmm mm

front view Side view Nebuliser tamper-evident

biocolour cap

AccESSOriES

ref

10009

10050

10051

10006

10047

10049

01356

Nebuliser

Tamper-evident bicolour cap

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Packaging for nasal applications

1

3

4

6

2

5

7

8

9

Spray and pump systems:Snap-on bottles

ml ml mmmm mm

SPEcificAtiONS

ref

35022 10 16,1 24 53 20

35023 15 18 24 58 20

35014 20 23 29 53 20

10

11

13

12

14

· Material: bottle HDPE· Available in other materials, sizes and designs· Reference to spray / pump supplier on request

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Packaging for parenteral applications

3

4

6

2

5

7

1

8

9

10

11

13

12

14

Product characeristics Product offering

· MultiShell® standard· MultiShell® ready-to-sterilise (includes certified Bioburden, Endotoxin and particle level)· MultiShell® ready-to-use (includes validated gamma sterilisation)

· Unique barrier properties· Superior break resistance· Inert against high and low pH· no metal ions· Low absorption

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Packaging for parenteral applications

1

3

4

6

2

5

7

8

9

MultiShell® vials (standard, RTS and RTU)

SPEcificAtiONS

10

11

13

12

14

ref ml ml mm mm

2R EN ISO 8362-1 2 3,5 16 35 3,6 13 7 2,7

6R EN ISO 8362-1 5 9,1 22 40 3,6 20 12,6 4,9

10R EN ISO 8362-1 10 12,5 24 45 3,6 20 12,6 6,1

15R EN ISO 8362-1 15 17 24 60 3,6 20 12,6 8,2

50H EN ISO 8362-4 50 67 42,5 73 3,8 20 12,6 16

100H EN ISO 8362-4 100 132,2 51,6 94,5 3,8 20 12,6 26,5

mmmm mm g

PrODuct PAckAGiNG AND fiNiSh DEScriPtiON

Production environment ISO 7

Packaging processing Fully automated

Packaging environment ISO 7

Packaging materials in Produced in ISO 7 direct contact with vials

Dimensions Accord. to standard specification

Defects Accord. to standard specification

Cleanliness Accord. to standard specification

Endotoxin Certified per batch; limit: EU

Particles Certified per batch; limit:

Bioburden Certified per batch; limit: cfu

Gamma radiation Validated sterilisation dose

Sterilisation Certified per batch / parametric release

Endotoxin test post sterilisation Certified per batch

Specification MultiShell®

StandardMultiShell®

rtSMultiShell®

rtu

www.gerresheimer.com

Europe

South America

Asia

More Information

Gerresheimer Plásticos São Paulo LtdaRodovia Raposo Tavares 25.599 – Km 25,606708-000 Cotia – São Paulo – BrazilTel. +55 11 4613 1000Fax +55 11 4613 1009

Gerresheimer Plásticos São Paulo LdtaRua Mario Regalo Pereira 160 / 17005550-060 Butantã – São Paulo – Brazil

triveni Polymers Pvt. Ltd.Plant KundliG.T. Road, Piao ManiyariKundli-131028 Distt. SonepatHaryana, India

Sales office New Delhi2-B, IInd Floor, DCM Building Barakhamba Road, Connaught Place New Delhi-110001, India

Gerresheimer Bolesławiec S.A.ul. Boleslawa Chrobrego 15 59-700 Bolesławiec – PolandTel. +48 75 735 04 00

Gerresheimer Valencia, S.L.u.Avda. Conchin Ferrer 146292 Masalavés – Valencia – SpainTel. +34 976 817 408

Gerresheimer tampas herméticas LtdaRua da Congregação 56 06816-902 Embu – São Paulo – BrazilTel. +55 11 2133 1212Fax +55 11 2133 1299

Gerresheimer Buenos Aires S.A.Mercedes 2153C1417AUA Buenos Aires – ArgentinaTel. +54 11 4639 0771Fax +54 11 4639 1041

[email protected]

Pharmaceutical Plastic Packaging and Systems for South America is to be found in a separate catalogue.

Gerresheimer Zaragoza, S.A.P.I. Valdemuel – Camino del Sabinar, s/n50290 Epila – Zaragoza – SpainTel. +34 976 817 408

Gerresheimer Vaerloese A/SWalgerholm 2 – 8 – 3500 Vaerloese DenmarkStrandgade 87 – 5683 Haarby DenmarkTel. +45 4477 7888

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