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Prefilled Syringes64

Issue No #64  February 10th, 2016


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Inside the magazine

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
Hekuma
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
Zeon Corporation
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
Chimera Consulting
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
Advanex
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.
INNOVATIVE ADVANCED DRUG DELIVERY PRODUCTS AND SERVICES THAT SATISFY FUNDAMENTAL NEEDS
PREFILLED SYRINGES
SHL Medical
INNOVATIVE ADVANCED DRUG DELIVERY PRODUCTS AND SERVICES THAT SATISFY FUNDAMENTAL NEEDS
SHL Group first explores the importance of fundamental design principles in injector design, as exemplified by the Molly® auto injector.
NOVEL APPROACHES & TECHNOLOGIES TO INCREASE PATIENT CONFIDENCE & DECREASE ANXIETY
PREFILLED SYRINGES
Joe Reynolds
Noble
NOVEL APPROACHES & TECHNOLOGIES TO INCREASE PATIENT CONFIDENCE & DECREASE ANXIETY
Joe Reynolds outlines some of the fundamental principles and benefits of training devices in the context of prefilled syringes, and highlights some specific training device technologies including novel needle simulators and angle aids.
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