PURE. PRECISE. PERFECT CONTENT 01 About Nipro Glass 1.1 History 1.2 Vertical Integration 1.3 Partnership 1.4 Our Goal 02 Our Products 2.1 Tubing 2.2 Vials 2.3 Ampoules 2.4 Cartridges 2.5 Syringes 2.6 Sterile Products 03 Technical Information 01. ABOUT NIPRO GLASS 60 Years of history in pharmaceutical market In July 1954, With a proud 60 year history of Nippon Glass Shoji Co. was established in pharmaceutical market service, Shimogyo-Ku of Kyoto city and initiated sales Nipro Glass provides unparalleled of glass tubes for use in the production of industry knowledge and expertise ampoules and pharmaceutical vials. to its customers. Almost 60 years after its establishment, Furthermore, our focus on invest- Nipro embarked on a journey to become a ments and responsive account major world class glass producer/supplier, management allows Nipro Glass to setting out to make a strong presence in the better partner with our customers glass packaging industry. to help meet and exceed their business goals. In 2011, Nipro acquired Amcor Glass, with factories located in France, Belgium and the United States of America, now respectively Nipro Glass France, Nipro Glass Belgium and Nipro Glass Americas. Further expansion continued with a *UHHQ¿HOG&RQYHUWLQJRSHUDWLRQLQ5XVVLDDQG a re-organized Tube Drawing facility in India. In 2012, Nipro acquired MGlass AG and MG Sterile Products AG, now Nipro Glass Germany and Nipro Sterile Glass Germany. Nipro Glass (Americas) Millville Chase City Westport Sales team factories Tubing and converting Converting Sterile product VERTICAL INTEGRATION With worldwide glass manufacturing and converting facilities located in Europe (France, Germany, Belgium), the US (Millville, Chase City, Westport), India, Indonesia, Japan, China and Russia, Nipro Glass is a vertically integrated global supplier of pharmaceutical tubular glass packaging, positioned to meet global demand and to provide continuity of supply to our customers. Our glass product range extends from tubing, vials, ampoules, cartridges to sterile syringes and vials under the trade mark D2F® (Direct-To-Fill). Nipro Glass (Europe) Nipro Glass (Russia) Grace au Hollogne Aumale Authon du Perche Lucenay des Aix Münnerstadt Nipro Glass (China) Münnerstadt Anyang Jilin Chengdu Meerut Khopoli Nipro Corporation (Japan) Agartala Badlapur Nipro Glass (India) Otsu Panvel Chiplun Nipro Glass (Indonesia) Karawan PARTNERSHIP In each business area of Nipro Corporation, we are focused on building a long-term partnership with each customer. From the silica sand used to make the glass, to the FXVWRPHU¶V¿OOLQJOLQHVHDFKVWHSRIWKHYDOXHFKDLQLVHVVHQWLDOLQGHOLYHULQJRQRXU promise of serving and enhancing patient care. Every Nipro employee understands this credo and is held accountable to deliver on this promise. World-class processes and controls ensure that our customers’ expectations are met. Our commitment is to work with our customers and to contribute to the greater mission. OUR GOAL IS ZERO-DEFECT QUALITY LEVELS 7RIDFLOLWDWHRSWLPDOHI¿FLHQF\LQ\RXU¿OOLQJOLQHVDQGPDLQWDLQSURGXFWLQWHJULW\ our glass products are designed and manufactured to the highest quality standards. World-class processes and controls ensure quality. We make billions of vials and ampoules on a daily basis knowing that each one can make a difference. Continuous Improvement Program The Nipro Quality Management System began with establishing a quality mindset. Our management team and our employees are committed to quality and we provide our employees with continuous training through In-House Technology • Fully automated machines • In-line camera inspection • Highest precision during forming process • 100% vision inspection progressive education. Within the Nipro Group, Continuous Improvement aims at maximizing More than 30 years of experience in building opportunities and making optimal use of existing forming machines allows us to better respond UHVRXUFHVWRHQKDQFHWKH&RPSDQ\¶VHI¿FLHQF\ to your needs and to design a forming machine and competitiveness. that meets your expectations. Our expert teams listen to your needs and use their skills, Nipro‘s Japanese quality standards combined versatility and expertise to meet your production with our in-line camera inspection system and and account management needs. 360° visual inspection and clean rooms class 8 not only allows us to deliver a superior product to our customers, but also provides means to capture and quantify our internal capabilities, so that we can continuously improve our processes. Best practice sharing is encouraged and utilized across our sites, all our sites are ,62FHUWL¿HG • • • • ISO 15378 ,62 ISO 14001 OHSAS 18001 02. OUR PRODUCTS TUBING HIGH QUALITY GLASS TUBING FOR PHARMACEUTICAL PACKAGING With state-of-the-art Danner and Vello drawing processes, our range of glass is particularly suited for vials, cartridges, injectable or drinking ampoules, GLVSRVDEOHPHGLFDOSURGXFWVDQGSUH¿OOHGV\ULQJHV Properties include excellent mechanical strength and thermal properties with maximum workability in customer transformation processes. Quality control spans all of our processes from the batch house, where raw materials are received and mixed; to the melting and forming processes; to WXEH¿QLVKLQJSDFNLQJDQGZDUHKRXVHVWRULQJ Manufacturing lines are equipped with in-line vision inspection systems that inspect every glass tube. Moreover, manual inspection comes as a back-up, in order to ensure that all quality parameters are met, both dimensional and cosmetic. W33 Type I Clear Borosilicate Glass - Low expansion neutral formulation High chemical durability Enhanced resistance to thermal shock Manufactured in Millville (USA) NSV51 Type I Clear Borosilicate Glass - Neutral formulation - Can also be manufactured with Cerium for gamma sterilization - Manufactured in Aumale (FR) and Millville (USA) WG6 Type III Clear Soda Lime Glass $OORXUJODVVW\SHVPHHWWKHVWDQGDUGVVSHFL¿HGE\ the current United States, European and Japanese Pharmacopeia (USP, EP and JP). - Can also be manufactured with Cerium for gamma sterilization - Manufactured in Millville (USA) NA54 Type I Amber Borocilicate Glass G38 Type III Half Neutral Borosilicate Glass - Amber colored glass which offers UV resistant properties - Well suited for injectable application - Manufactured in Aumale (FR) - Half-neutral yellow colored glass - UV resistant - Very stable to heat treatment and mechanical strength - Manufactured in Aumale (FR) VIALS GLASS VIALS FOR PHARMACEUTICAL USE Nipro Glass offers a standard product line of vials from 2ml to 50ml in different designs. These models have passed the test of time and are produced with consistency at our vial converting sites. According to industry standard or to your individual VSHFL¿FDWLRQVZHRIIHU&XVWRP'HVLJQYLDOV:H are able to build the perfect vial for your needs DFFRUGLQJWR\RXUVSHFL¿FGLPHQVLRQDORUFRVPHWLF requirement. • • • • • Type I Clear glass Type I Amber glass Better shape consistency Stronger thermal shock resistance Reduced contact with forming tools give a superior cosmetic appearance Pharmaceutical vials • Injection/ Infusion Vials • Screw Neck Vials • Large volume vials Special vials • • • • • • • Unit dose vial Bi-dose vial ProDose vial V-bottom vial High recovery vial Double chamber vial Clean vial Features Several features can be added to your Standard or Custom Design vial. • • • • 6SHFL¿FGLPHQVLRQDOWROHUDQFHV 100% vision and manual inspection Blowback (Type I or II) Various level of packaging (Cell Pack available) AMPOULES PRIMARY PACKAGING GLASS AMPOULES Glass ampoules are the ideal packaging material IRUÀXLGSUHSDUDWLRQV2XUDPSRXOHVDUH tamper-proof, transparent, durable, impermeable to gas and resistant to any interaction between container and content. Total product safety is guaranteed through these essential properties. Our standard range of ampoules offer you a wide variety of high-quality products. The quality of these products is monitored at every stage of the production process by on-line camera inspection for dimensional and visual criteria. • • • • Type I Clear glass Type I Amber glass Filling capacities from 1ml to 25ml Fine tip, Double tip, Straight-stem, Open funnel and Closed-stem ampoules • Various break systems such as OPC (One Point Cut), CBR (Colour Break Ring) and SCR (Score Ring) • Customized printing • Drug Master File Type III Quality • • • In-process control by statistical sampling Physical and chemical analysis according to US, EU and JP Pharmacopoeias Class 100 000 packaging rooms CARTRIDGES GLASS CARTRIDGES FOR DRUG DELIVERY SYSTEMS Nipro Glass cartridges are produced to meet the highest quality requirement of the pharmaceutical industry. Our standard cartridges range from 1.8ml WRPODUHVXLWDEOHIRUVWDQGDUG¿OOLQJDQG packaging equipment, injection systems like dental anesthetics, as well as other applications. Our high quality lines use visual inspection systems for 100% dimensional control and cosmetic defects. Final packaging is performed under controlled environmental conditions. • • • • Type I Clear glass Customized ceramic printing Drug Master File Type III Sizes from 1.8ml to 3.0ml, larger sizes on request SYRINGES WIDE RANGE OF PREFILLABLE GLASS SYRINGE SYSTEMS :HSURYLGHDZLGHUDQJHRISUH¿OODEOHV\ULQJH systems both as bulk products and in a ready-to-use format. These syringes under our trademark D2F® (Direct-To-Fill) are washed, siliconized and sterilized (ETO).System accessories complete the range and make our syringes deliverable as complete sets according to customer requirements. Components • Closure solutions for Luer-Lock cone, Luer-Slip cone and Bonded Needle • Plunger stoppers and rods in different rubber formulations • Type I Clear glass • Compliance with USP, EP, JP • 6XLWDEOHIRUVWDQGDUG¿OOLQJDQGSDFNDJLQJ equipment • Customized ceramic printing • Sizes from 0.5ml to 10.0ml • Drug Master File Type III Besides Glass Syringes, Nipro also offers a wide range of plastic syringes and needles. Further information on request. STERILE SOLUTIONS D2F® DIRECT-TO-FILL Nipro Sterile Glass products D2F® (Direct-To-Fill) are manufactured by washing, drying, siliconization and closure assembly on fully-automated, state-of-the-art washing and packaging lines. Validated washing and siliconization processes ensure the highest quality standards. Our D2F® syringes and vials are delivered pre-packed in a sterile packaging which is available in all common nest, tub and breather bag or tray, lid/front wall and breather bag. • Pre-packed sterile packaging for immediate ¿OOLQJ • Drug Master File Type III, available with FDA (USA) and HPFB (Canada) • Type I Clear glass • Compliance with USP, EP, JP • D2F® process steps: washing, siliconization, assembly, packaging • 360° visual inspection • Clean room according to pharmaceutical requirements • Fully automated lines including packaging D2F Direct To Fill TEST TUBES COLLECTION TUBES FOR LABORATORY EXPERIMENTS AND CHEMICAL ANALYSES Nipro Glass test tubes are ideal for simple experiments, in particular for chemical analyses. Our test tubes are manufactured from Type I borocilicate glass for a better resistance to heat, corrosive chemicals and a longer life. High quality and performance in laboratorium is ensured by our state-of-the-art production lines. • Type I Clear glass • Available in different sizes NOTES EUROPE NIPRO GLASS EUROPE Weihoek 3H 1930 Zaventem Belgium T: +32 (0)2 725 55 33 [email protected] www.niproglass.com United States of America NIPRO GLASS AMERICAS 1200 North 10th Street Millville, NJ 08332 T: +1 (0)856 825 1400 [email protected] www.niproglass.com PURE. PRECISE. PERFECT
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