PURE. PRECISE. PERFECT
CONTENT 01 About Nipro Glass 1.1 1.2 1.3 1.4 History Vertical Integration Partnership Our Goal 02 Our Products 2.1 2.2 2.3 2.4 2.5 2.6 Tubing Vials Ampoules Cartridges Syringes Sterile Products 03 Technical Information
01. ABOUT NIPRO GLASS
60 Years of history in pharmaceutical market
In July 1954, Nippon Glass Shoji Co. was established in Shimogyo-Ku of Kyoto city and initiated sales of glass tubes for use in the production of ampoules and pharmaceutical vials. With a proud 60 year history of pharmaceutical market service, Nipro Glass provides unparalleled industry knowledge and expertise to its customers. Almost 60 years after its establishment, Nipro embarked on a journey to become a major world class glass producer/supplier, setting out to make a strong presence in the glass packaging industry. 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. Furthermore, our focus on investments and responsive account management allows Nipro Glass to better partner with our customers to help meet and exceed their business goals. Further expansion continued with a 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).
Grace au Hollogne Nipro Glass (Europe) Nipro Glass (Russia) Aumale Authon du Perche Lucenay des Aix Münnerstadt Münnerstadt Nipro Glass (China) Anyang Jilin Chengdu Otsu Badlapur Khopoli Nipro Glass (India) Meerut Agartala Panvel Chiplun Nipro Corporation (Japan) 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 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 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 In-House Technology 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 progressive education. Within the Nipro Group, Continuous Improvement aims at maximizing opportunities and making optimal use of existing and competitiveness. Nipro s Japanese quality standards combined with our in-line camera inspection system and 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. Fully automated machines In-line camera inspection Highest precision during forming process 100% vision inspection More than 30 years of experience in building forming machines allows us to better respond to your needs and to design a forming machine that meets your expectations. Our expert teams listen to your needs and use their skills, versatility and expertise to meet your production and account management needs. Best practice sharing is encouraged and utilized across our sites, all our sites are ISO 15378 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, 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 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. the current United States, European and Japanese Pharmacopeia (USP, EP and JP). 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 - Can also be manufactured with Cerium for gamma sterilization - Manufactured in Millville (USA) NA54 Type I Amber Borocilicate Glass - Amber colored glass which offers UV resistant properties - Well suited for injectable application - Manufactured in Aumale (FR) G38 Type III Half Neutral Borosilicate Glass - 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 are able to build the perfect vial for your needs 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. 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 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. Quality In-process control by statistical sampling Physical and chemical analysis according to US, EU and JP Pharmacopoeias Class 100 000 packaging rooms 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
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 packaging equipment, injection systems like dental anesthetics, as well as other applications. Type I Clear glass Customized ceramic printing Drug Master File Type III Sizes from 1.8ml to 3.0ml, larger sizes on request Our high quality lines use visual inspection systems for 100% dimensional control and cosmetic defects. Final packaging is performed under controlled environmental conditions.
SYRINGES WIDE RANGE OF PREFILLABLE GLASS SYRINGE SYSTEMS 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 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 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 info@niproglass.com www.niproglass.com United States of America NIPRO GLASS AMERICAS 1200 North 10th Street Millville, NJ 08332 T: +1 (0)856 825 1400 info@niproglassamericas.com www.niproglass.com
PURE. PRECISE. PERFECT