High-Quality Pharmaceutical Plastic Packaging and · PDF fileHigh-Quality Pharmaceutical...
Transcript of 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
05/13 3
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.
05/13 4
05/13 5
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
05/13 6
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
05/13 7
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
05/13 8
05/13 9
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
05/13 10
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
05/13 11
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 12
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 13
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 14
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 15
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 16
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 17
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 18
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 19
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 20
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 21
Pharmaceutical Plastic Packaging
Packaging for ophthalmic applications
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
05/13 22
Pharmaceutical Plastic Packaging
05/13 23
Pharmaceutical Plastic Packaging
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
05/13 24
Pharmaceutical Plastic Packaging
05/13 25
Pharmaceutical Plastic Packaging
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
05/13 26
Pharmaceutical Plastic Packaging
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
05/13 27
Pharmaceutical Plastic Packaging
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
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