PREFILLED SYRINGES:WITH THE PATIENT & SAFETY AT
ITS CORE, THE MARKET RE-ALIGNS
OUTSTANDING ISSUE SPONSOR
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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
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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: firstname.lastname@example.org
tip-top.com Limited2, Moss RoadStanwayColchesterEssexCO3 0LEUnited Kingdom
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.
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