Ophthalmic, Nasal and Parenteral Applications - Gerresheimer

High-Quality 

Pharmaceutical Plastic 

Packaging and Systems 

for Ophthalmic, Nasal and 

Parenteral Applications 

www.gerresheimer.com

Gerresheimer Plastic Packaging 

Europe 

Gerresheimer Vaerloese | Denmark 

Gerresheimer Haarby | Denmark 

Gerresheimer Boleslawiec | Poland 

Gerresheimer Valencia | Spain 

Gerresheimer Zaragoza | Spain 

Asia 

Gerresheimer New Delhi | India 

Gerresheimer Kundli | India 

South America 

Gerresheimer São Paulo, Butanta | Brazil 

Gerresheimer São Paulo, Cotia | Brazil 

Gerresheimer São Paulo, Embu | Brazil 

Gerresheimer Buenos Aires | Argentina 

About Gerresheimer 

Gerresheimer is an internationally leading manufacturer of highquality 

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 delivery 

systems such as syringe systems, insulin pens and inhalers for 

safe medication dosage and application. Together with our partners, 

we develop solutions which set standards and have role model 

status in their respective market sectors. 

Our 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, convincing 

innovations and targeted investments to systematically consolidate 

our strong market position.

Gerresheimer Plastic Packaging Solutions 

Intelligent products for diverse pharmaceutical applications 

PET / Liquid & Solid 

Solid 

Ophthalmic, Nasal and Parenteral Applications 

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 become 

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 

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. 

· Solution providing 

· Good Manufacturing Practice (GMP) 

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

· Automated in-line controls 

· Vision-based inspection system 

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

Strong regulatory approach 

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. 

· High level of documentation and registration 

· Standard product database 

· FDA and world-wide registration of all products 

· US and Canada Drug Master File 

· Product registrations in Russia, China and the Ukraine 

· Food approval 

Strong quality culture 

A 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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Innovative and trendsetting 

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. 

· 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 

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

MultiShell ® vials. 

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 difference 

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 medications. 

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 unusual 

forces are applied, and predestines MultiShell ® vials as packaging 

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 multifunctional, 

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 

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Ophthalmic, nasal and parenteral applications 

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. 

· 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 

· 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 

ophthalmic 

1 

2 

Dropper bottles – 

System A 

3 

Accessories 

4 


System B 

5 

Accessories 

6 


System Q 

7 

Accessories 

8 


System CL 

9 

Accessories A1ST 

10 

Dropper bottles – System PR and CT 

11 

CLC bottles 

nasal 

12 

Spray bottles with nebuliser – System NEB 

13 

Spray and pump systems: Snap-on bottles 

parenteral 

14 

MultiShell ® vials (standard, RTS and RTU) 

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Pharmaceutical Plastic Packaging 

Packaging for ophthalmic applications 

1 

2 


System A (LDPE) 

3 

4 

5 

6 

7 

8 

9 

Specifications 

10 

11 

ref ml ml mm 

mm 

mm 

12 

13 

14 

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 

· Material: LDPE 

· Available in other materials, sizes and designs 

· Radiation or ETO sterilisation on request 

· Accessories: see page 12 and 13 

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System A (HDPE) 

1 

2 

3 

4 

5 

6 

7 

8 

9 


10 

ref ml ml mm 

mm 

mm 

11 

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 

12 

13 

14 

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

· Material: HDPE 



· Accessories: see page 12 and 13 

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1 

2 


System A: Accessories 

3 

4 

5 

Dropper 

Nozzle 

6 

7 

8 

9 

10 

11 

12 

Tamper-evident 

screw cap 


wing screw cap 

Child-resistant 

tamper-evident 

screw cap 

13 

14 

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1 

2 

3 

4 

5 

6 

7 

8 

9 


10 

ref Drops/ml +/- 20% 

ref 

11 

Dropper 

14110 21 

14166 23 

Tamper-evident screw cap 

15190 

15197 

12 

14182 24 

14213 22 

15233 

15255 

13 

14214 28 

Tamper-evident screw cap for nozzle 

15207 

14216 24 

14219 14 

Tamper-evident wing screw cap 

Child-resistant tamper-evident screw cap 

15250 

91176 

14 

Nozzle 

14180 – 

14222 – 

· Material: dropper LDPE, nozzle LDPE 


· Droppers and nozzles fit bottle sizes on page 10 and 11 

· Material: tamper-evident 

screw cap HDPE, tamper-evident wing 

screw cap HDPE, child-resistant 

tamper-evident screw cap HDPE 


· Caps fit bottle sizes on page 10 and 11 

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1 

2 


System B 

3 

4 

5 

6 

7 

8 

9 


10 

11 

ref ml ml mm 

mm 

mm 

12 

38005 5 7,1 19 44 16 x 2 

38010 10 14,2 25 53 16 x 2 

13 

14 




· Accessories: see page 15 

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System B: Accessories 

1 

2 

3 


screw cap 

Dropper 

4 

5 

6 

7 

8 

9 


10 


screw cap 

Dropper 

ref Drops/ml +/- 20% 

15015 – 

15016 – 

14004 21 

14002 18 

11 

12 

13 

· Material: dropper LDPE, tamper-evident screw cap HDPE 


· Droppers and caps fit bottle sizes on page 14 

14 

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1 

2 


System Q 

3 

4 

5 

6 

7 

8 

9 


10 

11 

ref ml ml mm 

mm 

mm 

12 

13 

14 

200 5 9 22 44 Q 

201 10 13 22 56 Q 

726 15 16 23 65 Q 



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System Q: Accessories 

1 

2 

3 

Dropper 


screw cap 

4 

5 

6 

7 

8 

9 


10 

ref 

mm 

11 

· Material: dropper LDPE, cap PP 

· Dropper and cap fit bottle sizes 

on page 16 

Dropper 

Tamper-evident screw cap 

10054 Q 

10055 Q 

12 

13 

14 

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1 

2 


System CL 

3 

4 

5 

6 

7 

8 

9 


10 

11 

ref ml ml mm 

mm 

mm 

12 

13 

14 

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 



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System CL: 

Accessories A1ST 

1 

2 

3 

Dropper 

Cap 

4 

5 

6 

7 

8 

9 


10 

ref 

mm 

11 

· Material: dropper LDPE, cap PP 

· Dropper and cap fit bottle sizes 

on page 18 

Dropper 

Cap 

10008 A1ST 

10005 A1ST 

12 

13 

14 

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1 

2 


System PR and CT 

3 

4 

5 

6 

7 

8 

9 


10 

11 

ref ml ml mm 

mm 

mm 

12 

13 

069* 30 35 31 73 PR 

247 15 19 23 73 PR 

249 30 35 28 89 PR 

* Available in LDPE 

14 

· Material: bottle HDPE, dropper LDPE, cap HDPE 

· Supplied with droppers and tamper-evident bicolour caps 

· Reference to spray / pump supplier on request 

accessories 

ref 

Dropper 

10040 

Tamper-evident bicolour cap 

01432 

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CLC bottles 

1 

2 

3 

4 

5 

6 

7 

8 

9 


10 

ref ml ml mm 

mm 

mm 

11 

058 120 140 41 133 ST2 

12 

13 

· Material: bottle HDPE, dropper LDPE, cap HDPE 

· Supplied with droppers and caps 

accessories 

14 

ref 

Dropper 

Cap 

10039 

10034 

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Packaging for nasal applications 

Spray bottles 

with nebuliser – 

System NEB 

Front view Side view Nebuliser Tamperevident 

biocolour 

cap 

1 

2 

3 

4 

5 

6 

7 

8 

9 


10 

ref ml ml mm 

mm 

mm 

11 

138 20 23 31 x 22 68 NEB 

139 30 40 39 x 26 77 NEB 

12 

accessories 

· Material: bottle LDPE, nebuliser LDPE, cap HDPE 

· Supplied with two different nebulisers and tamper-evident 

bicolour caps 14 

ref 

13 

Nebuliser 

Tamper-evident bicolour cap 

10009 

10050 

10051 

10006 

10047 

10049 

01356 

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Packaging for nasal applications 

Spray and pump systems: 

Snap-on bottles 

1 

2 

3 

4 

5 

6 

7 

8 

9 


10 

ref 

ml ml mm 

mm 

mm 

11 

35022 10 16,1 24 53 20 

35023 15 18 24 58 20 

35014 20 23 29 53 20 

· Material: bottle HDPE 


· Reference to spray / pump supplier on request 

12 

13 

14 

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Packaging for parenteral applications 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

Product characeristics 

· Unique barrier properties 

· Superior break resistance 

· Inert against high and low pH 

· no metal ions 

· Low absorption 

Product offering 

· MultiShell ® standard 

· MultiShell ® ready-to-sterilise 

(includes certified Bioburden, Endotoxin and particle level) 

· MultiShell ® ready-to-use 

(includes validated gamma sterilisation) 

13 

14 

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Packaging for parenteral applications 

MultiShell ® vials 

(standard, RTS and RTU) 

1 

2 

3 

4 


5 

6 

ref ml ml mm 

mm 

mm mm mm g 

7 

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 

8 

9 

10 

product packaging and finish description 

Specification MultiShell ® 

Standard 

MultiShell ® 

RTS 

MultiShell ® 

RTU 

11 

Production environment ISO 7 

Packaging processing 

Fully automated 

12 

Packaging environment ISO 7 

Packaging materials in Produced in ISO 7 

direct contact with vials 

13 

Dimensions 

Defects 

Accord. to standard specification 


14 

Cleanliness 


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 

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Europe 

South America 

Asia 

Gerresheimer Bolesławiec S.A. 

ul. Boleslawa Chrobrego 15 

59-700 Bolesławiec – Poland 

Tel. +48 75 735 04 00 

Gerresheimer Valencia, S.L.U. 

Avda. Conchin Ferrer 1 

46292 Masalavés – Valencia – Spain 

Tel. +34 976 817 408 

Gerresheimer Plásticos São Paulo Ltda 

Rodovia Raposo Tavares 25.599 – Km 25,6 

06708-000 Cotia – São Paulo – Brazil 

Tel. +55 11 4613 1000 

Fax +55 11 4613 1009 

Gerresheimer Plásticos São Paulo Ldta 

Rua Mario Regalo Pereira 160 / 170 

05550-060 Butantã – São Paulo – Brazil 

Triveni Polymers Pvt. Ltd. 

Plant Kundli 

G.T. Road, Piao Maniyari 

Kundli-131028 Distt. Sonepat 

Haryana, India 

Gerresheimer Zaragoza, S.A. 

P.I. Valdemuel – Camino del Sabinar, s/n 

50290 Epila – Zaragoza – Spain 

Tel. +34 976 817 408 

Gerresheimer Vaerloese A/S 

Walgerholm 2 – 8 – 3500 Vaerloese 

Denmark 

Strandgade 87 – 5683 Haarby 

Denmark 

Tel. +45 4477 7888 

Gerresheimer 

Tampas Herméticas Ltda 

Rua da Congregação 56 

06816-902 Embu – São Paulo – Brazil 

Tel. +55 11 2133 1212 

Fax +55 11 2133 1299 

Gerresheimer Buenos Aires S.A. 

Mercedes 2153 

C1417AUA Buenos Aires – Argentina 

Tel. +54 11 4639 0771 

Fax +54 11 4639 1041 

Sales office New Delhi 

2-B, IInd Floor, DCM Building 

Barakhamba Road, Connaught Place 

New Delhi-110001, India 

More Information 

info-plasticpackaging@gerresheimer.com 

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

www.gerresheimer.com

Ophthalmic, Nasal and Parenteral Applications - Gerresheimer

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