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INJECTION

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.
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.
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.
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.
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.
PACKAGING FOR INJECTABLE DRUG DELIVERY DEVICES
PREFILLED SYRINGES
Seán Egan
Nelipak Healthcare Packaging
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.
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.
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.
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 CRITICALITY OF ADHESIVE SELECTION FOR OPTIMAL TRANSDERMAL DRUG DELIVERY SYSTEMS
TRANSDERMAL
Megan Greth
THE CRITICALITY OF ADHESIVE SELECTION FOR OPTIMAL TRANSDERMAL DRUG DELIVERY SYSTEMS
Megan Greth and Gozde Karabiyik discuss why selecting the right adhesive for body-worn drug delivery systems – be they transdermal patches or wearable injection devices or pumps – is critical for a successful outcome.
INSIGHTS FROM THE YPSOMATE SMART CASE STUDY
PREFILLED SYRINGES
Dr Andreas Schneider
Ypsomed
INSIGHTS FROM THE YPSOMATE SMART CASE STUDY
Andreas Schneider provides insights into recent development activities at Ypsomed in the area of smart self-injection systems.
THE POWER OF DRUG-DEVICE COMPANY COLLABORATION
PREFILLED SYRINGES
Bill Welch
Phillips Medisize
THE POWER OF DRUG-DEVICE COMPANY COLLABORATION
During the Pharmapack Europe Conference (Paris, France) – at 4pm on Wednesday, February 10th, 2016 – Bill Welch, Chief Technology Officer, Phillips-Medisize Corporation, will give a lecture entitled “Integrated Development and Scale-Up of Combination Products”. Here, he provides us with a preview of his forthcoming Pharmapack talk.
AN INNOVATIVE SOLUTION TO ADDRESS SILICONE-RELATED CONCERNS
PREFILLED SYRINGES
Christian Herget
BD (Becton Dickinson & Company)
AN INNOVATIVE SOLUTION TO ADDRESS SILICONE-RELATED CONCERNS
Christian Herget explores the potential impacts of silicone coatings on prefilled syringe-based injectable biopharmaceutical combination products and recent advances at BD to reduce these impacts.
HIGH-END PREFILLABLE SYRINGES FOR INNOVATIVE BIOPHARMACEUTICALS
PREFILLED SYRINGES
Klaus Wanner
BBS Automation
HIGH-END PREFILLABLE SYRINGES FOR INNOVATIVE BIOPHARMACEUTICALS
HEKUMA provides detailed insights into how specific process challenges arose and describes a resulting manufacturing line that excels in precision, technical reliability and cleanliness of the manufacturing environment to produce a syringe featuring highest product performance attributes.
INTRODUCING A NOVEL CLASS OF ENGINEERED POLYMER
PREFILLED SYRINGES
Satoru Adachi
INTRODUCING A NOVEL CLASS OF ENGINEERED POLYMER
Satoru Adachi and Mark Nevitt highlight some of the concerns of using conventional glass for parenteral drug storage in prefilled syringes, and provide an update on ZEONEX® cycloolefin polymer (COP).
ASSESSING THE IMPACT ON DRUG DOSE DELIVERY OF PASSIVE SAFETY DEVICES
PREFILLED SYRINGES
Adrien Tisserand
Nemera
ASSESSING THE IMPACT ON DRUG DOSE DELIVERY OF PASSIVE SAFETY DEVICES
Adrien Tisserand reports findings from a comparative study on drug dose delivery of the company’s passive needle-safety platform, Safe’n’Sound®.
QUALITY & SYSTEMS USABILITY REQUIREMENTS
PREFILLED SYRINGES
Dr Michael Gross
QUALITY & SYSTEMS USABILITY REQUIREMENTS
Michael Gross and Adam Shames discuss US FDA quality system requirements for combination products, especially Design Controls, which includes the requirement to validate the design of the medical device constituent part of a combination/borderline product.
POLYMERS, GLASS AND PARTICULATES: CHOOSING THE BEST CONTAINMENT FOR CUTTING-EDGE BIOLOGICS
PREFILLED SYRINGES
Kevin Cancelliere
West Pharmaceutical Services
POLYMERS, GLASS AND PARTICULATES: CHOOSING THE BEST CONTAINMENT FOR CUTTING-EDGE BIOLOGICS
Kevin Cancelliere provides a run-down of the benefits that cyclic-olefin polymers syringes can bring compared with glass.
REDUCING PARTICULATES FROM METAL PRODUCTS IN MEDICAL DEVICES
PREFILLED SYRINGES
Graham Perkins
REDUCING PARTICULATES FROM METAL PRODUCTS IN MEDICAL DEVICES
Graham Perkins explains how, for medical device component manufactures, developing new methods to reduce particulates is becoming increasingly important.
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