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COMPANY SHOWCASE: HASELMEIER
PREFILLED SYRINGES
Volker Wirth
Haselmeier
COMPANY SHOWCASE: HASELMEIER
Haselmeier discusses its business philosophy and expands upon its range of injection pen devices.
INJECTING HUMAN FACTORS/USABILITY ENGINEERING INTO INJECTION DEVICE DESIGN
EXPERT VIEW
Dr Marc Egeth
INJECTING HUMAN FACTORS/USABILITY ENGINEERING INTO INJECTION DEVICE DESIGN
Fourth in a series of articles covering quality system requirements for medical devices used to deliver drugs and biologics and combination/borderline products, Marc Egeth, Patricia McGahern and Sarah Johnstone discuss use errors associated with marketed and in-development injection systems.
PRODUCT SHOWCASE: PREMIUMCOAT™
INJECTION
Anne Bailly
Aptar Pharma
PRODUCT SHOWCASE: PREMIUMCOAT™
Anne Bailey discusses Aptar Stelmi's PremiumCoat™, a novel range of coated elastomeric stoppers for biopharmaceuticals.
APPLYING DEVICE DESIGN CONTROL CORE PROCESSES
EXPERT VIEW
Lilli Zakarija
APPLYING DEVICE DESIGN CONTROL CORE PROCESSES
Lilli Zakarija examines the selection of off-the-shelf drug delivery devices by pharmaceutical and biologics companies.
BREAKING THE 1 ML BARRIER
PREFILLED SYRINGES
Christian Herget
BD (Becton Dickinson & Company)
BREAKING THE 1 ML BARRIER
Christian Herget and Vincent Herin, explores the evolution of innovative syringe-based combination products for the administration of biopharmaceutical drugs.
A CARTRIDGE-BASED DRUGDELIVERYSYSTEM FOR PUMP SYSTEMS
INJECTION
Hans Peter Manser
A CARTRIDGE-BASED DRUGDELIVERYSYSTEM FOR PUMP SYSTEMS
Ludwig Weibel describes small, easy-to-use cartridge-based drug delivery systems and discusses how Weibel's system incorporates all the parts needed for a specific drug application into one product.
THE DRIVE UNIT OF THE PATCH PUMP
WEARABLES
Dr Gerhard Mayer
THE DRIVE UNIT OF THE PATCH PUMP
Gerhard Mayer and Sandra de Haan describe how, together with their pharmaceutical partner scPharmaceuticals (Lexington, MA, US) and Buehler Motor, developed the drive mechanism for a new, soon-to-be launched patch pump.
ASSESSING THE IMPACT ON DRUG DOSE DELIVERY OF A TWO-STEP AUTOINJECTOR
PREFILLED SYRINGES
Isabelle Delcroix
Nemera
ASSESSING THE IMPACT ON DRUG DOSE DELIVERY OF A TWO-STEP AUTOINJECTOR
Isabelle Delcroix introduces a two-step autoinjector platform, Safelia, which incorporates innovative and patented design features that enable it to deliver a both fluid and viscous formulations from standard glass prefilled syringes.
COMPANY SHOWCASE: CREDENCE MEDSYSTEMS
PREFILLED SYRINGES
John Merhige
Credence MedSystems
COMPANY SHOWCASE: CREDENCE MEDSYSTEMS
John Merhige overviews the offerings of Credence Medsystems, the Companion Product Family, and the company's Innovation Without Change philosophy.
PACKAGING FOR INJECTABLE DRUG DELIVERY DEVICES
PREFILLED SYRINGES
Seán Egan
PACKAGING FOR INJECTABLE DRUG DELIVERY DEVICES
Seán Egan and Angela Shotton describe how Nelipak’s transit tray solutions are comfortably keeping pace with current and future trends in the pharma and biopharma industry.
CREATING A DEVICE-COMPARABLE TRAINER TO ADDRESS INDUSTRY CHALLENGES
PREFILLED SYRINGES
Mike Siemer
Noble
CREATING A DEVICE-COMPARABLE TRAINER TO ADDRESS INDUSTRY CHALLENGES
Mike Siemer reports on the development of training devices that replicate the design and operation of the autoinjectors so patients can better understand how to use them.
ENHANCING THE PERFORMANCE OF DRY POWDER INHALERS: BREATH ACTUATED MECHANISMS
PULMONARY
Alan Tweedie
ENHANCING THE PERFORMANCE OF DRY POWDER INHALERS: BREATH ACTUATED MECHANISMS
David Lewis and Alan Tweedie explain how BAMs work and present experimental data demonstrating their ability to control dose delivery.
PRODUCT SHOWCASE: DF30 WITH COCe: ULTRA-CLEAN, ROBUST & VERSATILE
RESPIRATORY
Aptar Pharma
PRODUCT SHOWCASE: DF30 WITH COCe: ULTRA-CLEAN, ROBUST & VERSATILE
Aptar Pharma’s new DF30 metering valve version incorporates a cyclic-olefincopolymer (COC) neck gasket to enhance its performance further. It is the result of continuous improvement to today’s worldleading DF30 technology platform.
COMPANY SHOWCASE: NOBLE
PULMONARY
Noble
COMPANY SHOWCASE: NOBLE
Noble®, the leader in onboarding and device training, is a full-service, patient-centred product development and manufacturing company.
SYSTEMS ENGINEERING FOR COMPLEX PORTABLE DRUG DELIVERY DEVICE DEVELOPMENT
PULMONARY
Bill Welch
Phillips-Medisize
SYSTEMS ENGINEERING FOR COMPLEX PORTABLE DRUG DELIVERY DEVICE DEVELOPMENT
Bill Welch explains how a systems-engineering approach provides an efficient method of developing smaller, smarter and more complex inhaler devices.
COMPANY SHOWCASE: NOVI
PULMONARY
Adam Smith
Copley Scientific
COMPANY SHOWCASE: NOVI
In December 2015 the inhaler automation specialists Novi Systems launched their latest product, a ten-way shake and fire system for pMDIs called DecaVertus. Novi continues to innovate, bringing efficiency, precision and repeatability to inhalation labs around the world.
IT’S JUST AN APP, ISN’T IT?
PULMONARY
Vaishali Kamat
Cambridge Consultants
IT’S JUST AN APP, ISN’T IT?
Vaishali Kamat and Jaquie Finn, outline some key questions that pharma companies should ask before embarking on the development of a connected health solution, and provide insights that could help companies make the most from their investment.
BIOEQUIVALENCE FOR NASAL SPRAYS: IMPORTANCE OF DEVICE PERFORMANCE
NASAL
Pascale Farjas
Nemera
BIOEQUIVALENCE FOR NASAL SPRAYS: IMPORTANCE OF DEVICE PERFORMANCE
Pascale Farjas describes the company’s Device Equivalence Program, which enables Nemera to preselect and propose an appropriate delivery system per identified drug to companies wishing to save time in their nasal spray development pipeline.
OPTIMAL SOLUTION FOR DIFFERENT INSPIRATIONAL RATES
PULMONARY
Dr Gabriela Dujovny
Qualicaps
OPTIMAL SOLUTION FOR DIFFERENT INSPIRATIONAL RATES
There is a wide range of devices available to deliver inhalation therapies, but there is increasing interest in the use of dry powder inhalers due to improved engineering and powder formulations. Gabriela Dujovny looks at the advantages and disadvantages of the DPIs currently available.
ADVANCES IN PULMONARY DELIVERY OF INHALED ANTI-INFECTIVES
PULMONARY
Dr David L Hava
ADVANCES IN PULMONARY DELIVERY OF INHALED ANTI-INFECTIVES
With the growing problems caused by antimicrobial resistance, there is increasing interest in the use of improved strategies for drug delivery. David L. Hava explores the benefits of nebulised inhaled antibiotics delivered via high throughput nebulisers for aqueous formulations or dry powder inhalations for cystic fibrosis patients.
FDA ISSUES FINAL GUIDANCE ON MEDICAL DEVICE HUMAN FACTORS STUDIES
RESPIRATORY
Dr Michael Gross
FDA ISSUES FINAL GUIDANCE ON MEDICAL DEVICE HUMAN FACTORS STUDIES
Michael Gross and Adam Shames discuss US FDA draft recommendations on human factors validation which are part of the design validation requirement of device design controls.
VACCINE DELIVERY USING THE NEMAURA SOLID DOSE INJECTOR
MICRONEEDLES
David Scott
VACCINE DELIVERY USING THE NEMAURA SOLID DOSE INJECTOR
Joanne Broadhead and Karmen Cheung report an investigation into the delivery of two vaccines using Nemaura Pharma’s solid-dose injection technology.
US FDA ISSUES GUIDANCE ON HUMAN FACTORS STUDIES FOR COMBINATION PRODUCTS
INJECTION
Dr Michael Gross
US FDA ISSUES GUIDANCE ON HUMAN FACTORS STUDIES FOR COMBINATION PRODUCTS
Adam Shames and Michael Gross summarise the US FDA’s recently released draft Guidance: “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development”.
THE RAPID EVOLUTION OF THE TRANSDERMAL DRUG DELIVERY INDUSTRY SPAWNS INNOVATION
MICRONEEDLES
Luis Tissone
Trelleborg
THE RAPID EVOLUTION OF THE TRANSDERMAL DRUG DELIVERY INDUSTRY SPAWNS INNOVATION
Luis Tissone outlines technological developments behind microneedle design including the use of advanced liquid silicone rubber (LSR) and two-component injection technology, and explores the advantages this route offers over traditional intramuscular routes.

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Corning Incorporated

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