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Product Portfolio PRODUCT PORTFOLIO GLASS TUBING, PHARMACEUTICAL PACKAGING, LABORATORY SERVICES, ACCESSORIES FOR KIT-PACKAGING PHARMAPACKAGING FUELED BY INNOVATION, QUALITY, AND PARTNERSHIP Nipro PharmaPackaging is a leading global manufacturer of glass primary packaging in the pharmaceutical industry. For more than 60 years, we have developed and manufactured an innovative portfolio of Japanese quality products, including pre-fillable syringes, vials, cartridges, and ampoules. Our state of the art manufacturing plants and premium quality products comply to the highest quality standards (ISO 15378, ISO 9001, ISO 14001) of the industry. Through our personnel, products, and services, we provide packaging solutions that contribute to optimizing drug safety and efficacy, ultimately ensuring safer and healthier administrations. Vertically integrated You will benefit from the know-how and synergies of a vertically integrated company. As a glass tubing manufacturer, continued supply of consistent high quality glass tubing is a given. Upon defining your primary packaging, state of the art converting lines, equipped with the latest inspection technologies, yield precise dimensional and cosmetic results – Be it pre-fillable syringes, cartridges, vials, or ampoules. For exceptional packaging challenges, our highly trained laboratory service team will collaborate with you to analyze the situation and find convincing solutions. You can choose from a wide range of accessories, which can be by-packed with your primary container to improve the end-user experience. 2 Benefits of cooperating with a vertically integrated partner Glass Tubing Primary Packaging Advising you on glass tubing Offering you primary packaging that suits you best that matches your drug product requirements Laboratory Services Accessories for Kit-packaging Optimizing your packaging Enabling you to differentiate your characteristics drug product The optimal packaging solution for your drug product 3 Glass Tubing EXPERTISE REFLECTED IN GLASS To satisfy all the specifications of your final packaging, we begin with glass tubing. Nipro offers you professional advice on which glass tubing will serve as the optimal raw material for your primary packaging by meeting your dimensional and cosmetic requirements. Ensuring continuous supply of glass tubing, while keeping a consistent high quality, is essential for the production of premium containers. Our global network, with a capacity of more than 90,000 metric tons, is one of the largest in the glass tubing industry. Our sites are ISO 9001, ISO 15378, and OHSAS 18001 certified. Our premium glass tubing complies to the European Pharmacopoeia, Japanese Pharmacopeia, and United States Pharmacopoeia. Our commitment to Japanese quality is reflected by using the latest manufacturing equipment, combined with an extensive array of dimensional and cosmetic inspection systems. To provide the same high quality and professional service at every manufacturing site, all facilities are aligned in terms of production, quality assurance, and supply chain. With decades of experience in supplying a broad range of high quality clear and amber glass tubing to leading players of the pharmaceutical industry, Nipro has acquired the expertise to advise you on the glass tubing that is best suited for your primary container and ultimately for your drug product. NSV51* W33 WG06* G38 Clear Clear Clear Amber Boroslicate Borosilicate Soda Lime Borosilicate Type I Type I Type III Type III Exp.: 51 Exp.: 33 Exp.: 93 Exp.: 76 * Optional with cerium Advising you on glass tubing that suits you best 4 Quality Levels FOR PHARMACEUTICAL PACKAGING In an increasingly competitive market environment, pharmaceutical companies are facing substantial challenges when confronted with the choice of the right drug delivery system. On one side, a growing number of complex biotech drugs require highly sophisticated systems, while generic drugs primarily focus on cost effectiveness and fast time to market. Safeguarding patients, as the principle objective, results in even stricter standards amid rising end-user expectation in terms of safe and easy to use systems. As a result, primary packaging, an inherent part of drug delivery systems, must meet the challenging requirements of pharmaceutical companies, regulatory standards, and end-users alike. The process of defining the right quality for your primary packaging, in order to meet your drug product requirements, is a complex process. To facilitate the process, you can choose from three distinct quality levels that address varying drug product requirements. They form the perfect base to capture and fine- tune your quality and service requirements. Quality fine-tuned to your drug product requirements! Level of Customization & Product Complexity 5 Pre-fillable Syringes PRIMARY PACKAGING Nipro offers pre-fillable syringes in eNable, eNhance, and eNgage quality. Your fast, efficient solution for The optimal choice for highly Customize your syringe prevailing drug products sensitive drugs (Large molecules, specifications to meet particular (Small molecules, anticoagulants, vaccines, biotechs, cosmetics, drug product requirements that WFI, diluents) ophthalmics) surpass the eNhance quality level. • Optimized processability for • Excellent drug-container reduced TCO compatibility • Full data package for fast • Smooth integration into auto- acceptance of goods injection devices • Designed for reliable and safer • Optimized processability for manual administration minimal drug loss Syringe Size & Type Volume (ml) Outer Ø (mm) Inner Ø (mm) Staked needle Luer Luer lock 0.5 6.85 4.65 • • • 1.0 std. 8.15 6.35 • • • 1.0 long 10.85 8.65 • • • 2.25 10.85 8.65 • • • 3.0 10.85 8.65 • • Staked Needle Outer Ø (G | mm) Inner Ø (mm) Free length (inch | mm) Bevel Wall type 25 | 0.50 0.30 ⅝ | 16.0 V-bevel Regular 27 | 0.40 0.20 ½ | 12.7 V-bevel Regular 27 | 0.40 0.26 ½ | 12.7 V-bevel Thin 29 | 0.33 0.13 ½ | 12.7 V-bevel Regular 29 | 0.33 0.19 ½ | 12.7 V-bevel Thin 30 | 0.30 0.12 ½ | 12.7 V-bevel Ultra-thin 6 Syringe Components CLOSURE Staked needle Luer lock Luer SNS RNS LInC™ V-OVS® Easy-turn Ribbed Tip cap Tip cap Plunger stopper Plunger rod Safety devices Standard Transparent Safe’N’Sound Coated Color Novaguard - - Ypsomed Rubber components are supplied by the prevailing manufacturers of the pharmaceutical industry Specialty syringes Dual Chamber Syringe Dual chamber syringes combine the storage of a powdered/liquid drug and a diluent into one primary packaging. By simply exerting pressure on the plunger, the liquid of the lower chamber is forced into the chamber that houses the drug product. Afterwards, the content of both chambers can be mixed and easily administered. Syringe with Integrated Nasal Spray We offer compact-sized, multidose intranasal sprays for more convenient and accurate administrations. 7 Direct-To-Fill STERILE PACKAGING SOLUTIONS Our fully automated packaging process takes place in an ISO 7 / ISO 8 cleanroom with 100% monitoring under laminar air flow. Nest & tub are cleaned with ionized air Washed syringes are loaded into nest & tub Covered with insert(s) and sealed with lid (Tyvek®) Sealed tub is entered into breather bag(s) and welded closed 100% camera inspection confirms each tub is correctly filled & sealed Tubs are transferred into outer boxes Outer boxes are placed on pallets and secured for safe transportation External sterilization is performed & EtO exposure is confirmed by the indicator on the label Key Technologies ETO No glass-to-glass EtO sensitive 100% in-line Cleaned with contact indicator on label camera inspection ionized air 8 Glass Vials PRIMARY PACKAGING Nipro, with more than 60 years of experience, offers a wide range of vials in three distinct quality levels (eNable, eNhance, and eNgage) that answer to your specific drug requirements. .vials that answer to the prevailing ..vials that are the optimal choice …vials that are customized to requirements of drug products, for highly sensitive drugs, such as meet extraordinary drug product such as small molecules. biotechs and large molecules. requirements. These vials feature optimized They offer excellent drug-container processability for reduced TCO compatibility, exceptional surface and are provided with a full data durability (Vialex™), and optimized package for fast acceptance of processability for minimized drug goods delivered. waste. Vial Range d2 Crimp neck Volume (ml) d1 (mm) d2 (mm) h (mm) s (mm) 2R 16 13 35 1 4R 16 13 45 1 6R 22 20 40 1 8R 22 20 45 1 10R 24 20 40 1 h 15R 24 20 60 1 s 20R 30 20 55 1.2 25R 30 20 64 1.2 30R 40 20 75 1.2 50R 40 20 73 1.5 75 47 28 75 1.7 75 47 20 75 1.5 d1 75 47 32 75 1.95 75 40 20 100 1.5 Blowback: EU / US / None 100R 47 20 95 1.5 Surface: Ammonium sulfate 100 47 28 95 1.5 treatment / VIALEX™ 100 47 23 95 1.95 Printing: Ceramic 9 d2 Screw neck Volume (ml) d1 (mm) d2 (mm) h (mm) s (mm) 5 18 14 45 1.2 7.5 22 18 40 1.2 10 24 18 45 1.2 15 24 18 60 1.2 20 30 22 55 1.2 25 30 22 65 1.2 h 30 30 22 75 1.2 s 50 40 22 / 28 / 32 73 1.5 60 40 22 / 28 / 32 80 1.5 70 40 22 / 28 / 32 90 1.5 75 40 22 / 28 / 32 95 1.5 75 47 22 / 28 / 32 80 1.7 80 47 22 / 28 / 32 85 1.7 90 47 22 / 28 / 32 90 1.7 Blowback: EU / US / None | Surface: Ammonium sulfate treatment / VIALEX™ d1 Printing: Ceramic d2 Unit / Bi-dose Volume (ml) d1 (mm) d2 (mm) h (mm) s (mm) 0.35 6.6 8.75 19.5 0.8 0.5 6.6 8.75 28 0.8 h s d1 Specialty vials We offer a broad range of special and customized vials: High recovery High pressure V-bottom 10 Direct-To-Fill STERILE PACKAGING SOLUTIONS Our fully automated packaging process takes place in an ISO 7 / ISO 8 cleanroom with 100% monitoring under laminar air flow.
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