High-Quality Pharmaceutical Plastic Packaging and Systems

Transcription

1 High-Quality Pharmaceutical Plastic Packaging and Systems for Ophthalmic, Nasal and Parenteral Applications

2 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 a leading global partner to the pharma and healthcare industry. With our specialty glass and plastic products, we contribute to health and well-being. We have worldwide operations and our,000 employees manufacture our products in local markets, close to our customers. With over 0 plants in Europe, North America, South America and Asia, we generate revenues of more than EUR. billion. Our comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

3 Gerresheimer Plastic Packaging Solutions Intelligent products for diverse pharmaceutical applications PET / Liquid & Solid Solid Dosages Ophthalmic, Nasal and Parenteral Applications Gerresheimer Plastic Packaging specializes in the widely varied spectrum of pharmaceutical plastic packaging within solid, liquid 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. 0/

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5 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 00, ISO, ISO 00) Automated in-line controls Vision-based inspection system Class (0,000) + class (00,000) 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 Continuous improvements Systematic problem solving Quality by design Stable, robust, reliable and validated processes Risk-based approach 0/

6 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 coercial production line and offer now,, 0,, 0 and 00 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 0/

7 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., DMF no. 0/

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9 Content ophthalmic System A Accessories System B Accessories System D Accessories System E Accessories 0 System CL Accessories AST System PR and CT CLC bottles nasal Spray bottles with nebuliser System NEB Spray and pump systems: Snap-on bottles parenteral MultiShell vials (standard, RTS and RTU) 0/

10 Packaging for ophthalmic applications System A (LDPE) 0 ref ml ml 0, x 0, x 0 0, x 0 0 x 0, x 00 x 0 0 x x x 0 x 0 x 0, 0 x 0 0 x Material: LDPE Available in other materials, sizes and designs Radiation or ETO sterilisation on request Accessories: see page and Gerresheimer offers logistic and organisational activities with ordering and sending products for sterilisation. Gerresheimer s customers have full responsibility regarding sterilisation, validation and sterility assurance. 0/ 0

11 Packaging for ophthalmic applications System A (HDPE) 0 ref ml ml 0*, x 0*, x 0, x 00 0, x 0, x 0 0 x 0 x x 0 x 0 0, x 0 0 x * Material: PP Limited availability (further information upon request) Material: HDPE Available in other materials, sizes and designs Radiation or ETO sterilisation on request Accessories: see page and Gerresheimer offers logistic and organisational activities with ordering and sending products for sterilisation. Gerresheimer s customers have full responsibility regarding sterilisation, validation and sterility assurance. 0/

12 Packaging for ophthalmic applications System A: Accessories Dropper Nozzle 0 Tamper-evident screw cap Tamper-evident wing screw cap Child-resistant tamper-evident screw cap 0/

13 Packaging for ophthalmic applications 0 ref Drops/ml +/- 0% ref Dropper 0 Tamper-evident screw cap 0 Tamper-evident screw cap for nozzle Tamper-evident wing screw cap 0 0 Child-resistant tamper-evident screw cap Nozzle 0 Material: dropper LDPE, nozzle LDPE Available in other materials, sizes and designs Droppers and nozzles fit bottle sizes on page 0 and 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 0 and 0/

14 Packaging for ophthalmic applications System B 0 ref ml ml 00, x 00 0, x Material: LDPE Available in other materials, sizes and designs Radiation or ETO sterilisation on request Accessories: see page Gerresheimer offers logistic and organisational activities with ordering and sending products for sterilisation. Gerresheimer s customers have full responsibility regarding sterilisation, validation and sterility assurance. 0/

15 Packaging for ophthalmic applications System B: Accessories Tamper-evident screw cap Dropper 0 Tamper-evident screw cap Dropper ref Drops/ml +/- 0% Material: dropper LDPE, tamper-evident screw cap HDPE Available in other materials, sizes and designs Droppers and caps fit bottle sizes on page 0/

16 Packaging for ophthalmic applications System D 0 ref ml ml 0 0,, x Material: LDPE Available in other materials, sizes and designs Radiation or ETO sterilisation on request Accesssories: see page Gerresheimer offers logistic and organisational activities with ordering and sending products for sterilisation. Gerresheimer s customers have full responsibility regarding sterilisation, validation and sterility assurance. 0/

17 Packaging for ophthalmic applications System D : Accessories Tamper-evident screw cap Dropper 0 Tamper-evident screw cap Dropper ref Drops/ml +/- 0% 00 0 Material: dropper LDPE, tamper-evident screw cap HDPE Available in other materials, sizes and designs Droppers and caps fit bottle sizes on page 0/

18 Packaging for ophthalmic applications System E 0 ref ml ml 0*, 0, x 00 0,, 0, x Accessories fitting to ref 0 can be found under Dropper bottles - System A: Accessories on page - Material: LDPE Available in other materials, sizes and designs Radiation or ETO sterilisation on request Accesssories: see page Gerresheimer offers logistic and organisational activities with ordering and sending products for sterilisation. Gerresheimer s customers have full responsibility regarding sterilisation, validation and sterility assurance. 0/

19 Packaging for ophthalmic applications System E : Accessories Tamper-evident screw cap Dropper 0 Tamper-evident screw cap Dropper ref 0 0 Material: dropper LDPE, tamper-evident screw cap HDPE Available in other materials, sizes and designs Droppers and caps fit bottle sizes on page 0/

20 Packaging for ophthalmic applications System CL 0 ref ml ml 0 AST 0 0 AST 0 AST AST AST 0 AST AST Material: ml bottle LDPE, 0 0ml bottle HDPE Radiation or ETO sterilisation on request Accessories: see page Gerresheimer offers logistic and organisational activities with ordering and sending products for sterilisation. Gerresheimer s customers have full responsibility regarding sterilisation, validation and sterility assurance. 0/ 0

21 Packaging for ophthalmic applications System CL: Accessories AST Dropper Cap 0 ref Material: dropper LDPE, cap PP Dropper and cap fit bottle sizes on page 0 Dropper Cap 000 AST 000 AST 0/

22 Packaging for ophthalmic applications System PR and CT 0 ref ml ml 0* 0 PR PR 0 PR * Available in LDPE 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 000 Tamper-evident bicolour cap 0 0/

23 Packaging for ophthalmic applications CLC bottles 0 ref ml ml ST Material: bottle HDPE, dropper LDPE, cap HDPE Supplied with droppers and caps accessories ref Dropper Cap /

24 Packaging for nasal applications Spray bottles with nebuliser System NEB Front view Side view Nebuliser Tamperevident biocolour cap 0 ref ml ml 0 x NEB 0 0 x NEB Material: bottle LDPE, nebuliser LDPE, cap HDPE Supplied with two different nebulisers and tamper-evident bicolour caps accessories ref Nebuliser Tamper-evident bicolour cap 0 0/

25 Packaging for nasal applications Spray and pump systems: Snap-on bottles 0 ref ml ml 0 0, Material: bottle HDPE Available in other materials, sizes and designs Reference to spray / pump supplier on request 0/

26 Packaging for parenteral applications 0 Product characteristics Product offering Unique barrier properties Superior break resistance Inert against high and low ph No metal ions Low absorption MultiShell standard MultiShell ready-to-sterilise (includes certified Bioburden, Endotoxin and Particle Level) MultiShell ready-to-use (includes validated Gaa Sterilisation) 0/

27 Packaging for parenteral applications MultiShell vials (standard, RTS and RTU) ref ml ml g R EN ISO -,,, R EN ISO -, 0, 0,, 0R EN ISO - 0,, 0,, R EN ISO - 0, 0,, 0H EN ISO - 0,, 0, 00H EN ISO - 00,,,, 0,, product packaging and finish description 0 Specification MultiShell Standard MultiShell RTS MultiShell RTU Production environment ISO Packaging processing Fully automated Packaging environment ISO Packaging materials in Produced in ISO 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 Gaa radiation Validated sterilisation dose Sterilisation Certified per batch / parametric release Endotoxin test post sterilisation Certified per batch 0/

28 Europe South America Asia Gerresheimer Bolesławiec S.A. ul. Boleslawa Chrobrego -00 Bolesławiec Poland Tel Gerresheimer Valencia, S.L.U. Avda. Conchin Ferrer Masalavés Valencia Spain Tel. + 0 Gerresheimer Plásticos São Paulo Ltda Rodovia Raposo Tavares. Km, Cotia São Paulo Brazil Tel Fax + 00 Gerresheimer Plásticos São Paulo Ldta Rua Mario Regalo Pereira 0 / Butantã São Paulo Brazil Triveni Polymers Pvt. Ltd. Plant Kundli G.T. Road, Piao Maniyari Kundli-0 Distt. Sonepat Haryana, India Gerresheimer Zaragoza, S.A. P.I. Valdemuel Camino del Sabinar, s/n 00 Epila Zaragoza Spain Tel. + 0 Gerresheimer Vaerloese A/S Walgerholm 00 Vaerloese Denmark Strandgade Haarby Denmark Tel. + Gerresheimer Plásticos São Paulo Ltda Rua da Congregação 0-0 Embu São Paulo Brazil Tel. + Fax + Gerresheimer Buenos Aires S.A. Mercedes CAUA Buenos Aires Argentina Tel. + 0 Fax + 0 Sales office New Delhi -B, IInd Floor, DCM Building Barakhamba Road, Connaught Place New Delhi-000, India More Information info-plasticpackaging@gerresheimer.com Pharmaceutical Plastic Packaging and Systems for South America is to be found in a separate catalogue.