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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES

PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES
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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES

Product catalog summary
Overview
Nipro PharmaPackaging is a prominent provider of primary packaging and medical devices for the pharmaceutical industry, ensuring a stable supply of high-quality glass tubing through its vertically integrated operations and multiple state-of-the-art plants worldwide.
Product Portfolio
  • Glass Tubing: Offers borosilicate and soda lime glass tubing, compliant with regulatory standards and customizable for specific packaging needs.
  • Pre-fillable Glass Syringes: Designed for optimal drug-container compatibility, suitable for auto-injection devices with customizable specifications.
  • Glass Vials: Feature precise parameters and VIALEX™ technology for enhanced durability.
  • Glass Ampoules: Economical and reliable, designed for easy opening and fill-finish operations.
  • Glass Cartridges: Used in diabetes pens and dental systems, customizable and high-quality.
  • Reconstitution Devices: Facilitate safer drug reconstitution, reducing contamination risks.
  • Hypodermic Needles: Designed for minimal vessel damage and easy integration into automated processes.
  • Nasal Sprays: Exadose™ nasal sprays offer uniform performance, part of the D2F™ prefilled syringes portfolio.
Quality and Support
Nipro adheres to strict quality systems (ISO 15378, ISO 9001, ISO 45001, ISO 14001, ISO 50001) and provides comprehensive customer support, including regulatory assistance, technical support, and laboratory services.
Customization and Quality Levels
Offers three distinct quality levels for primary packaging, allowing customization to meet specific drug product requirements, supported by an experienced team.
Global Manufacturing Network
Operates numerous plants in North America, Europe, and Asia, ensuring local supply and consistent product quality.
Laboratory Analysis Services
Advanced laboratories in the USA and Germany offer a wide range of analyses, including glass fracture analysis and extractables studies, staffed by skilled personnel for standard and customized analyses.
Technical Customer Support
Provides comprehensive technical support for complex primary packaging, with experienced engineers managing projects and quality inquiries.
Regulatory Affairs Support
The Global Regulatory Affairs team assists with drug product registration, providing necessary documentation and handling regulatory queries.
Company Overview
Nipro PharmaPackaging, part of Nipro Corporation Japan, specializes in advanced pharmaceutical packaging products, with 15 manufacturing plants and multiple sales offices worldwide, serving the Pharmaceutical, Medical Device, and Pharma Packaging industries.
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Catalog excerpts

PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-1

PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-2

Strategic Business Partner F O R P R I M A R Y PA C K A G I N G A N D M E D I C A L D E V I C E S Nipro PharmaPackaging is an established market leader in the development and manufacture of primary packaging and medical devices in the pharmaceutical industry. Vertically integrated As a vertically integrated company, we draw our own premium glass tubing in multiple state-of-the-art plants worldwide. The integration of this step in-house ensures a stable supply of raw materials with a consistent high quality to our glass converting plants. Extensive Experience For over 60 years, we’ve been developing...

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-3

Global Manufacturing Network Your products are manufactured within our broad manufacturing network. We operate numerous state-ofthe-art plants in North America, Europe, and Asia enabling local supply and the possibility to source the same high-quality products from multiple sites. Comprehensive Customer Support Products and technologies constantly increase in complexity. Our comprehensive and competent support organization comprising regulatory assistance, technical support, and laboratory services will address all your inquiries quickly and efficiently. Commitment to Quality When medication...

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-4

The process of defining the right quality of your primary packaging to meet your drug product requirements is a complex process. Multiple parameters need to be considered to ensure the right match. Parameters influencing the required primary container quality Drug Complex biotech drugs require highly sophisticated packaging solutions when it comes to drug-container compatibility. (silicone amount, tungsten levels, particles, ...) Attributes that are essential when the container is combined with a device. (mechanical glass durability, dimensional aspects, ...) Any data required to confirm compliance...

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-5

With decades of experience in manufacturing high-quality glass tubing for the pharmaceutical industry, Nipro has acquired the expertise to advice you on the glass tubing that is best suited for your primary container. Fast and reliable converting-line performance Very strict cosmetic parameters Highly precise dimensional attributes Customize your glass tubing parameters to meet specific primary packaging quality and service requirements that differ from the current quality levels Meeting highest regulatory and quality requirements Customization is fully supported by an experienced and dedicated...

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Pre-fillable Glass Syringes F O R P H A R M A C E U T I C A L A P P L I C AT I O N S The careful selection of raw materials and precisely-controlled manufacturing processes yield D2F ™ pre-fillable glass syringes that are made exactly for their intended applications, offering the right quality for prevailing drug products as well as challenging Biotech drugs. Optimized processability for reduced TCO Excellent drug-container compatibility Designed for reliable and safer manual administration Smooth integration into autoinjection devices Customize your syringe specifications to meet specific primary...

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Syringe Size & Type Volume (ml) Staked needle Free length (inch | mm) Wall type V-bevel V-bevel V-bevel V-bevel V-bevel V-bevel Regular Regular Thin Regular Thin Ultra-thin Luer lock Staked Needles Components Needle shield Plunger stoppers Safety devices Soft needle shield Hard needle shield LInC V-OVS® Easy-turn tip cap Ribbed tip cap Standard Coated Safe’N’Sound® Novaguard® Ypsomed® Rubber components are supplied by the prevailing manufacturers of the pharmac

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-8

D2F Sterile Packaging Direct To Fill Our fully automated packaging process takes place in an ISO 7 / ISO 8 cleanroom with 100% monitoring under laminar air flow. EtO sensitive indicator on label 100% in-line camera inspection Cleaned with ionized air 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...

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-9

Nipro vials are characterized by precise dimensional and pristine cosmetic parameters. The carefully-controlled specifications enable a smooth integration on fill-finish lines. Our glass vials are made from high-quality glass tubing offering secure storage of drug products. Nipro’s proprietary VIALEX™ technology offers exceptional glass surface durability for highly sensitive drugs. Fast and reliable filling-line performance Outstanding drug-container compatibility Compliant with prevailing quality standards Optimized filling-line performance Customize your vial specifications to meet unique...

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Crimp neck Volume (ml) Surface Ammonium sulfate treatment VIALEX ™ Screw neck Volume (ml) Ammonium sulfate treatment VIALEX ™

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PRODUCT PORTFOLIO GLASS TUBING, PRIMARY PACKAGING, AND MEDICAL DEVICES-11

Unit / Bi-dose Volume (ml) Specialty vials We offer a broad range of special and customized vials such as high recovery vials, V-bottom vials, and double chamber vials.

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Economical and well-proven, glass ampoules are a frequently selected primary packaging type by the pharmaceutical industry. Nipro offers a wide range of high-quality ampoules. Benefits Precisely Formed for Fill-Finish Operations Nipro ampoules are carefully monitored during the manufacturing process. The 100% in-line visual camera inspection ensures precise dimensional forming of the ampoules according to agreed quality specifications. The ampoules support quick and easy fill-finish operations. Stable Break Force Facilitates Easy Opening The force necessary to open an ampoule is an essential...

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Form B Outer Ø – Body (mm) Form B Form Form Form B Form B B B Code rings Printing Surface treatment Breaking system Double Tip Double Double Double Double TipTipTipTip Fine Tip Fine Fine Tip Fine Tip Fine TipTip Form D Form Form Form D Form DDD Form C Form Form Form C Form C C C Form B | Form C | Form D | Fine Tip Ceramic (max. 2 colors) With or w/o Teflon (natural fiber brush) Color Break Ring, Open Point Cut, Scoring Ring

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.