PREFILLED SYRINGES - ONdrugDelivery Magazine

1 SYRINGES :WITH THE PATIENT & safety AT ITS CORE, THE MARKET RE-ALIGNSOUTSTANDING ISSUE SPONSORI njectables0534_GF_Pre filled SYRINGES September 10534_GF_Pre filled SYRINGES September 104/10/2011 22:0504/10/2011 22:052 CONTENTSThe views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher makes no claim that it is free of error. Nor does the publisher accept liability for the consequences of any decision or action taken (or not taken) as a result of any information contained in this Needle Technologies from tip-top Gaining Recognition Amongst Syringe ManufacturersBarry Liversidge, Managing Limited 4-6 Transforming a Clinical safety Device into a Viable Self-Injection OptionAlexander Jaksch, Vice-President, Business Development & MarketingSafety SYRINGES , Inc 8-10 Differentiation Without DisruptionAlan Shortall, Chief Executive OfficerUnilife Corporation 13-16 COMPANY PROFILE Teamtechnik 18-19 Developing Containers and Devices to Meet Emerging and Evolving Parenteral NeedsDr Justin M.

2 Wright, Director, Pharmaceutical Development BD Medical - Pharmaceutical Systems 22-24 Integrated Drug Containment and Delivery Solutions to Meet Evolving Patient and Market NeedsGraham Reynolds, Vice-President, Marketing & Innovation, Pharmaceutical Delivery SystemsWest Pharmaceutical Services, Inc 28-30 COMPANY PROFILE - Bespak Injectables 32-33 Coated Plungers: Peace of Grueninger, Global Marketing & Business Development ManagerDatwyler 34-36 Improving Particulate & Microbial Cleanliness of Elastomeric ClosuresStelmi 38-40 Advanced Technology for a New Generation of Sterile Needle-Free Plastic PREFILLED SyringesDanielle Labreche, Director, Business Development & InnovationLaboratoire Aguettant 44-46 Matching a Range of Injectors with both Patients and Pharma Partners NeedsIan Thompson, Vice-President Business Development, Delivery SystemsYpsomed Delivery Systems 48-50 PREFILLED SYRINGES .

3 With The Patient & safety At Its Core, The Market Re-Aligns This edition is one in the ONdrugDelivery series of pub-lications from Frederick Furness Publishing. Each issue focuses on a specific topic within the field of drug deliv-ery, and is supported by industry leaders in that CALENDAR 2011: October: Oral Drug Delivery November: Pulmonary & Nasal Drug Delivery (OINDP) December: Delivering BiotherapeuticsSUBSCRIPTIONS: To arrange your FREE subscription (pdf or print) to ONdrugDelivery , contact:Guy Furness, PublisherT: +44 (0) 1273 78 24 24E: feature your company in ONdrugDelivery , contact:Guy Furness, PublisherT: +44 (0) 1273 78 24 24E: ADDRESS:Frederick Furness Publishing48, Albany Villas, Hove, East Sussex, BN3 2 RWUnited KingdomPRODUCTION/DESIGN:Mark Frost PREFILLED SYRINGES .

4 With The Patient & safety At Its Core, The Market Re-Aligns is published by Frederick Furness 2011 Frederick Furness Publishing. All rights reserved Copyright 2011 Frederick Furness Publishing0534_GF_Pre filled SYRINGES September 20534_GF_Pre filled SYRINGES September 204/10/2011 22:0504/10/2011 22:050534_GF_Pre filled SYRINGES September 30534_GF_Pre filled SYRINGES September 304/10/2011 22:0504/10/2011 22:05 Copyright 2011 Frederick Furness Publishing4 Today worldwide, there are five principal man-ufactures of standard glass SYRINGES BD, Gerresheimer, Schott, Nuova Ompi and MGlas and, to all intents and purposes, these compa-nies make almost identical prefillable syringe products to very similar specifications.

5 However, none of these syringe producers markets a prefillable syringe with inbuilt inte-grated needlestick protection; which means that pharmaceutical companies buying from these syringe makers, must then secondary-package their injectable drug products, with clip-on accessories to provide some form of needlestick protection because this is the only way to comply with requirements for syringe-based injectable drugs to be marketed with safety -engineered sharps is important to consider why there are five independent manufactures producing almost identical pre-fillable syringe products; espe-cially as the expression product differentiation seems to domi-nate the drug delivery industry.

6 Nevertheless it is a fact, that the vast majority of parenteral drugs are packaged almost identically because over many years the pre- filled syringe has become a uni-versally preferred way to supply a ready-to-use injectable drug, and therefore pharmaceutical compa-Barry LiversidgeManaging DirectorT: +44 1206 564 994F: +44 1206 578 953E: Limited2, Moss RoadStanwayColchesterEssexCO3 0 LEUnited this article, Barry Liversidge, Managing Director at tip-top, provides an update on how discussions with pharmaceutical companies and syringe manufacturers have confirmed that tip-top s minim and mini-Max safety needle systems offer a simple, safe, and cost effective way to provide passive needlestick protection for PREFILLED SYRINGES .

7 safety -ENGINEERED NEEDLE TECHNOLOGIES FROM TIP-TOP GAINING RECOGNITION AMONGST SYRINGE MANUFACTURERSH istorically, oranges were a popular choice for training injection techniques, because the outer peel and inner pulp simulates the feel of performing an injection. SYRINGE MANUFACTURERS AND PHARMACEUTICAL COMPANIES RECOGNISE HOW TIP-TOP S MINI-MAX SYSTEM WILL INTEGRATE PASSIVE NEEDLESTICK PROTECTION ONTO READY-TO-FILL SYRINGES WITHOUT HAVING TO REDESIGN THE PRIMARY DRUG CONTAINER. 0534_GF_Pre filled SYRINGES September 40534_GF_Pre filled SYRINGES September 404/10/2011 22:0504/10/2011 22:05 Copyright 2011 Frederick Furness Publishing have generated a huge demand for a universal multi-sourced product, and this demand has been satisfied by these five syringe however, the proliferation of needle-stick legislation throughout the world, threatens the utility of the PREFILLED syringe because, whilst the ready-to-use convenience of the pre- filled syringe defines its utility, if the syringe is not provided with safety -engineered needlestick protection, then it is not !

8 The mini-Max system can enable existing manufactures to provide prefillable SYRINGES with integrated passive needlestick protection, without having to redesign the primary drug container. And because the mini-Max system can be fitted to any manufacturer s syringe, the pharmaceutical industry s demand for a multi-sourced universal product , is easily their launch at the 2010 PDA Universe of PREFILLED SYRINGES and Injection Devices con-ference in Las Vegas, NV, US, tip-top s innova-tive needlestick prevention technologies have been well received by both device manufac-tures and pharma companies. The minim and mini-Max devices, have attracted considerable interest from the major stakeholders in all quar-ters of the injectable drug delivery industry.

9 And in particular syringe manufacturers and pharma-ceutical companies recognise how tip-top s mini-Max system could integrate passive needlestick protection onto ready-to-fill SYRINGES without having to redesign the primary drug mini-Max system is designed to main-tain the fusion that exists between elastomeric super-compact and lightweight robust design guards against needle-stick injury before during and after use securely packaged with tamper evident closure, ideal for inclusion into parenteral drug offering minimum size minimum cost minimum riskINTEGRATED NEEDLESTICK PROTECTION from this next-generation safety needle which has no metal spring and uses only a few plastic components to lower costs and reduce sharps , compact and yet robust, this safety needle provides protection before, during and after PASSIVE safety NEEDLE FOR LUER CONNECTION TO ANY SYRINGEF igure 1: mini-Max is fitted by the syringe manufacturer onto standard SYRINGES .

10 There are no compatibility issues with existing ready-to-fill infrastructures. IT IS IMPORTANT TO CONSIDER WHY THERE ARE FIVE INDEPENDENT MANUFACTURES PRODUCING ALMOST IDENTICAL PREFILLABLE SYRINGE PRODUCTS. 0534_GF_Pre filled SYRINGES September 50534_GF_Pre filled SYRINGES September 504/10/2011 22:0504/10/2011 22:05 Copyright 2011 Frederick Furness Publishing6component manufactures and syringe produc-ers; so that passive needlestick protection can be integrated onto existing PREFILLED SYRINGES , without major changes to Drug Master , the mini-Max system is fit-ted by the syringe manufacturer onto standard SYRINGES before the SYRINGES are nested into the popular ready-to-fill Tray & Tub format.