Prefilled Syringes & Injection Devices101

Issue No #101 Oct 2019 October 2nd, 2019

Inside the magazine

SUCCESS FACTORS FOR THE YPSOMATE FAMILY OF AUTOINJECTORS

Orfeo Niedermann

SUCCESS FACTORS FOR THE YPSOMATE FAMILY OF AUTOINJECTORS

Orfeo Niedermann looks at the key factors behind the growth and continued success of the YpsoMate family of two-step autoinjectors. He also introduces YpsoMate Design, which enables freeform outer shell design around the proven YpsoMate mechanism and manufacturing lines.

THE INTERFACE BETWEEN PREFILLED SYRINGE AND AUTOINJECTOR – A DEVELOPMENT FRAMEWORK

Dr Jeffrey Philippson

THE INTERFACE BETWEEN PREFILLED SYRINGE AND AUTOINJECTOR – A DEVELOPMENT FRAMEWORK

Jeffrey Philippson and Tom Kemp outline the challenges for autoinjector developers at the interface between the device and the prefilled syringe – and describe a framework to formalise analysis of the interface.

SIMPLIFYING THE PROCESS OF DEVELOPING PREFILLED SYRINGES

West Pharmaceutical Services

SIMPLIFYING THE PROCESS OF DEVELOPING PREFILLED SYRINGES

Tibor Hlobik describes how the use of cyclic olefin polymer delivery systems is gaining in popularity because of the benefits they have over glass systems for complex drug applications, and explains what this advance in technology can offer drug manufacturers.

30 YEARS IN THE MAKING – AN INSIDE PERSPECTIVE ON THE EMERGENCE OF AUTOINJECTORS

Michael McGowan

30 YEARS IN THE MAKING – AN INSIDE PERSPECTIVE ON THE EMERGENCE OF AUTOINJECTORS

Michael McGowan, Director of Market Intelligence at SHL Group, gives a perspective on the emergence of the autoinjector as a key component of the drug delivery industry, in the context of SHL celebrating its 30th anniversary this year – a journey of rapid development that reflects the growing demand for advanced drug delivery systems in the healthcare market.

DEVELOPMENTS IN SELF-INJECTION DEVICES FOR COMBINATION PRODUCTS

Dr Fred Metzmann

DEVELOPMENTS IN SELF-INJECTION DEVICES FOR COMBINATION PRODUCTS

Fred Metzmann reports on the latest state-of-the-art developments in innovative injection devices for combination products in subcutaneous self-application. He outlines Haselmeier's product platform strategy for single-use (D-Flex) and re-usable (i-pen²) injection-pen systems, and related services and looks at the company’s connected digital solutions.

LED-GENERATED UV FOR ADHESIVE CURING IN MEDICAL DEVICES

PREFILLED SYRINGES

LED-GENERATED UV FOR ADHESIVE CURING IN MEDICAL DEVICES

Roland Lindner, Matthias Schulze and Bill Jaworski discuss how the needs around adhesive use in the manufacture of medical devices such as glass syringes have evolved and how ATS sortimat has developed a new process to meet industry demands.

F2V: A STERILE, CUSTOMISABLE LIQUID FILL-FINISH PLATFORM FOR THE TOTAL LIFECYCLE

INDUSTRIALISATION

Simon Strothers

F2V: A STERILE, CUSTOMISABLE LIQUID FILL-FINISH PLATFORM FOR THE TOTAL LIFECYCLE

Simon Strothers presents an integrated fill-finish platform, F2V, designed to represent a commercial filling system as a bench-top solution. The article also includes a recent case study where the F2V was used by Consort Medical to help develop and industrialise a flagship delivery device.

PATIENTS, MANUFACTURERS & PRACTITIONERS CAN LEAD ADOPTION OF CONNECTED COMBINATION PRODUCTS

Napoleon Monroe

PATIENTS, MANUFACTURERS & PRACTITIONERS CAN LEAD ADOPTION OF CONNECTED COMBINATION PRODUCTS

Napoleon Monroe asks why connectivity has failed to advance rapidly, and argues that many stakeholders can benefit if the adoption of connectivity for drug delivery can be accelerated. While this article will centre on pharmaceutical combination products, the essential points also relate more broadly to pharmaceuticals and medical devices.

ASSESSING USABILITY EARLY FOR OPTIMAL INJECTION PEN DESIGN

ASSESSING USABILITY EARLY FOR OPTIMAL INJECTION PEN DESIGN

David Fink and Stefan Gaul use the example of Haselmeier’s D-Flex system to explain why it is important to undertake a full use-related risk analysis for injection pen products to assess their usability and identify any risks, highlighting the importance of considering usability right from the start.

LATEST UPDATE ON OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE

PREFILLED SYRINGES

Tomohiro Suzuki

Mitsubishi Gas Chemical

LATEST UPDATE ON OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE

Tomohiro Suzuki gives an update on the development of the OXYCAPT™ multilayer plastic vial and syringe – highlighting the results of recent tests comparing it with existing glass syringes.

Z.BLIZZARD AUTOMATION SYSTEM FOR PFS: IMPROVING THE LIVES OF PATIENTS

INDUSTRIALISATION

Berthold Schopferer

Z.BLIZZARD AUTOMATION SYSTEM FOR PFS: IMPROVING THE LIVES OF PATIENTS

With the ultimate objective of improving patients’ lives, Berthold Schopferer provides an overview of the company’s customer-specific automated manufacturing and assembly equipment offering for prefillable polymer syringes.

PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform

INDUSTRIALISATION

Wolfgang Moersch

PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform

ZwickRoell provides an overview of its parenteral device testing platform including roboTest, and associated software testXpert III and autoEdition3.

FUNCTION-BASED PRIMARY PACKAGING DESIGN FOR INJECTING VISCOUS NON-NEWTONIAN FORMULATIONS

FUNCTION-BASED PRIMARY PACKAGING DESIGN FOR INJECTING VISCOUS NON-NEWTONIAN FORMULATIONS

Marta Vilaplana; Alex Vasiev and Susie White explore the challenges of delivering high-viscosity, non-Newtonian fluids emphasising the importance of robust tools to characterise specific device and formulation parameters in light of increasing regulatory scrutiny.

8 MM NEEDLE – IMPROVING SUBCUTANEOUS CHRONIC DRUG DELIVERY

PREFILLED SYRINGES

BD (Becton Dickinson & Company)

8 MM NEEDLE – IMPROVING SUBCUTANEOUS CHRONIC DRUG DELIVERY

Aurelie Pager describes how reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker, and highlights BD’s development programme for an innovative shorter needle with ultra-thin walls for prefilled syringes.

CO-PACKAGED COMPONENTS IMPROVE PATIENT EXPERIENCE AND ENSURE CONSISTENT DRUG DELIVERY

CO-PACKAGED COMPONENTS IMPROVE PATIENT EXPERIENCE AND ENSURE CONSISTENT DRUG DELIVERY

Chris Franzese and Amy Rinaldi explore the challenges and benefits of co-packaging for manufacturers, healthcare workers and patients.

HOW CONNECTIVITY ADDS VALUE TO INJECTABLE DRUG DELIVERY DEVICES

Dr Iain Simpson

Phillips-Medisize

HOW CONNECTIVITY ADDS VALUE TO INJECTABLE DRUG DELIVERY DEVICES

In the context of the growing shift in emphasis from improving adherence to the better outcomes that can arise from doing so, Iain Simpson discusses why connectivity is becoming increasingly important in injectable drug delivery, and how it can benefit patients, providers and pharmaceutical manufacturers.

ADDING VALUE TO PREFILLED SYRINGES: SAFETY AND CONNECTIVITY

Chantal Wierckx

ADDING VALUE TO PREFILLED SYRINGES: SAFETY AND CONNECTIVITY

Chantal Wierckx and Arnaud Guillet provide an update on Newguard™, Biocorp’s integrated safety device for prefilled syringes, and explore the possible advantages connectivity can bring in the context of traceability for anti-counterfeiting, in clinical trials and in vaccination campaigns.

DEVELOPING DEMONSTRATORS TO INCREASE PATIENT CONFIDENCE AND REDUCE ANXIETY

PREFILLED SYRINGES

DEVELOPING DEMONSTRATORS TO INCREASE PATIENT CONFIDENCE AND REDUCE ANXIETY

Joe Reynolds discusses the value of demonstrators for making patients comfortable and effective with their prefilled syringe, leading to a significant improvement in treatment adherence and patient quality of life.

Gerresheimer Expands Gx RTF<sup>®</sup> ClearJect<sup>®</sup> Product Line

PREFILLED SYRINGES

Mr Maximilian Vogl

Gerresheimer Expands Gx RTF^® ClearJect^® Product Line

Maximilian Vogl describes how Gerresheimer is expanding its range of prefillable polymer syringes to include a new product: the Gx RTF^® ClearJect^® polymer syringe, 2.25 mL.

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