PREFILLED SYRINGES - ONdrugDelivery Syringes Sep 2011...COMPANY PROFILE – Teamtechnik 18 ... Graham Reynolds, Vice-President, Marketing Innovation, ... be integrated onto existing

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  • www.ondrugdelivery.com

    PREFILLED SYRINGES:WITH THE PATIENT & SAFETY AT

    ITS CORE, THE MARKET RE-ALIGNS

    OUTSTANDING ISSUE SPONSOR

    Injectables

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    CONTENTS

    The 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 publication.

    Safety-Engineered Needle Technologies from tip-top Gaining Recognition Amongst Syringe ManufacturersBarry Liversidge, Managing Directortip-top.com 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. 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 MindPatrick 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: 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 field.

    EDITORIAL CALENDAR 2011: October: Oral Drug Delivery November: Pulmonary & Nasal Drug Delivery (OINDP) December: Delivering Biotherapeutics

    SUBSCRIPTIONS: To arrange your FREE subscription (pdf or print) to ONdrugDelivery, contact:Guy Furness, PublisherT: +44 (0) 1273 78 24 24E: guy.furness@ondrugdelivery.com

    SPONSORSHIP/ADVERTISING:To feature your company in ONdrugDelivery, contact:Guy Furness, PublisherT: +44 (0) 1273 78 24 24E: guy.furness@ondrugdelivery.com

    MAILING ADDRESS:Frederick Furness Publishing48, Albany Villas, Hove, East Sussex, BN3 2RWUnited Kingdom

    PRODUCTION/DESIGN:Mark Frost www.frostmark.co.uk

    Prefilled Syringes: With The Patient & Safety At Its Core, The Market Re-Aligns is published by Frederick Furness Publishing.

    Copyright 2011 Frederick Furness Publishing. All rights reserved

    www.ondrugdelivery.com Copyright 2011 Frederick Furness Publishing

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  • www.ondrugdelivery.com 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.

    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 protection.

    It 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.

    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 Director

    T: +44 1206 564 994F: +44 1206 578 953E: barry.liversidge@tip-top.com

    tip-top.com Limited2, Moss RoadStanwayColchesterEssexCO3 0LEUnited Kingdom

    www.tip-top.com

    In 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-tops minim and mini-Max safety needle systems offer a simple, safe, and cost effective way to provide passive needlestick protection for prefilled syringes.

    SAFETY-ENGINEERED NEEDLE TECHNOLOGIES FROM TIP-TOP GAINING RECOGNITION AMONGST SYRINGE MANUFACTURERS

    Historically, 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-TOPS

    MINI-MAX SYSTEM WILL INTEGRATE

    PASSIVE NEEDLESTICK PROTECTION

    ONTO READY-TO-FILL SYRINGES

    WITHOUT HAVING TO REDESIGN THE

    PRIMARY DRUG CONTAINER.

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  • Copyright 2011 Frederick Furness Publishing www.ondrugdelivery.com 5

    nies have generated a huge demand for a universal

    multi-sourced product, and this demand has

    been satisfied by these five syringe producers.

    Today 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 ready-to-use..!

    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 manufacturers syringe, the

    pharmaceutical industrys demand for a multi-

    sourced universal product, is easily satisfied.

    Since their launch at the 2010 PDA Universe

    of Prefilled Syringes and Injection Devices con-

    ference in Las Vegas, NV, US, tip-tops 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; and

    in particular syringe manufacturers and pharma-

    ceutical companies recognise how tip-tops mini-

    Max system could integrate passive needlestick

    protection onto ready-to-fill syringes without

    having to redesign the primary drug container.

    The 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 risk

    INTEGRATED 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 waste.

    Small, compact and yet robust, this safety needle provides protection before, during and after injection.

    minimPASSIVE SAFETY NEEDLE FOR LUER CONNECTION TO ANY SYRINGE

    Figure 1: mini-Max is fitted by the syringe manufacturer onto standard syringes. 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.

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  • www.ondrugdelivery.com Copyright 2011 Frederick Furness Publishing6

    component manufactures and syringe produc-

    ers; so that passive needlestick protection can

    be integrated onto existing prefilled syringes,

    without major changes to Drug Master Files.

    Furthermore, the mini-Max system is fit-

    ted by the syringe manufact