Prefilled Syringes & Injection Devices129

Issue No #129 Feb 2022 February 21st, 2022

Issue 129 - Feb 2022

Inside the magazine

A VIEW ON THE USE OF APROTIC SOLVENTS IN PARENTERAL DRUG FORMULATIONS

A VIEW ON THE USE OF APROTIC SOLVENTS IN PARENTERAL DRUG FORMULATIONS

Michael Neely presents a review and discussion of the status of aprotic solvents as a solubilising vehicle for parenteral drug formulations in the context of the industry’s increasing interest in biologic drugs.

HOW MODEL BASED DEFINITION REVOLUTIONISES THE PRODUCTION OF MEDICAL DEVICES

INDUSTRIALISATION

HOW MODEL BASED DEFINITION REVOLUTIONISES THE PRODUCTION OF MEDICAL DEVICES

Rob Doorakkers looks at the advantages of the IGS GeboJagema’s Model Based Definition process and its ability to improve the quality of medical device production.

COMPUTATIONAL MODELLING OF INJECTION-RELATED TISSUE RESPONSES IN DRUG DELIVERY

Asmita Khanolkar

COMPUTATIONAL MODELLING OF INJECTION-RELATED TISSUE RESPONSES IN DRUG DELIVERY

Olivia Jefferies, Elizabeth Margerison and Asmita Khanolkar introduce Oval’s work on using ultrasound scanning and finite element analysis to construct a model of how tissue compresses under use of an autoinjector across patient demographics, and how this may provide insights into improved autoinjector design for more accurate injection depths, improving patient outcomes.

DRUG DELIVERY DEVICE TRENDS FOR 2022

DRUG DELIVERY DEVICE TRENDS FOR 2022

Tom Oakley looks at some of the current trends in the drug delivery industry and projects some of the key factors that will influence drug delivery decision making in 2022.

SO FAR SO GOOD: MAINTAINING THE MOMENTUM OF PROGRESS FOR SUSTAINABLE POLICIES

SO FAR SO GOOD: MAINTAINING THE MOMENTUM OF PROGRESS FOR SUSTAINABLE POLICIES

Michael Earl discusses the highlights of a review undertaken by Owen Mumford into how the pharmaceutical industry is faring on environmental, social and governance standards, noting that while the industry is performing above average overall, there remain some key areas for improvement.

VOICE-ACTIVATED USER INTERFACES IN DRUG DELIVERY DEVICES CAN ENHANCE COMPLIANCE AND OUTCOMES

Salvatore Forte

VOICE-ACTIVATED USER INTERFACES IN DRUG DELIVERY DEVICES CAN ENHANCE COMPLIANCE AND OUTCOMES

Salvatore Forte looks at the evolution of voice-activated interfaces in medical devices, particularly autoinjectors, and the advantages for patient compliance and quality of care.

MDR COMPLIANCE: PLANNING FOR POST-MARKET CLINICAL FOLLOW-UP

Dr Celeste Maksim

MDR COMPLIANCE: PLANNING FOR POST-MARKET CLINICAL FOLLOW-UP

Celeste Maksim discusses best practices for drug delivery device manufacturers when conducting post-market clinical follow-up activities, as mandated by the EU Medical Device Regulation.

TAKING INTEGRATED NEEDLE SAFETY SYSTEMS FOR PREFILLED SYRINGES TO THE NEXT LEVEL

PREFILLED SYRINGES

Michelle Deutsch

TAKING INTEGRATED NEEDLE SAFETY SYSTEMS FOR PREFILLED SYRINGES TO THE NEXT LEVEL

Michelle Deutsch and John Merhige discuss the needle safety requirements of prefilled syringes and consider how SCHOTT TOPPAC^® and syriQ^® PFS with Credence Companion^® technology combine to meet these challenges, while ensuring the device meets sustainability demands.

NEW BD SCF™ PREMIUMCOAT<sup>®</sup> 1MLL PLUNGER STOPPER: GLIDING TOWARDS DE-RISKED COMBINATION PRODUCT DEVELOPMENT

PREFILLED SYRINGES

BD (Becton Dickinson & Company)

NEW BD SCF™ PREMIUMCOAT^® 1MLL PLUNGER STOPPER: GLIDING TOWARDS DE-RISKED COMBINATION PRODUCT DEVELOPMENT

Victoria Meyer introduces the BD SCF™ PremiumCoat^® 1mlL Plunger Stopper and explains how the product’s role is critical in determining combination products’ exposure to extractables and leachables.

EVOLVING ANALYTICAL METHODS: ADVANCES IN MOLECULE CHARACTERISATION

EVOLVING ANALYTICAL METHODS: ADVANCES IN MOLECULE CHARACTERISATION

Eliza Lee discusses some of the modern analytical techniques available for the characterisation of modern biologics, and how CDMOs equipped with these techniques are able to support pharmaceutical development.

FROM VIAL TO PREFILLED SYRINGE: MIGRATING A DRUG PRODUCT PRESENTATION

PREFILLED SYRINGES

Dr Martin Gonzalez

Pfizer CentreOne

FROM VIAL TO PREFILLED SYRINGE: MIGRATING A DRUG PRODUCT PRESENTATION

Martin Gonzalez discusses some of the most relevant engineering activities that are necessary to transfer a product successfully from a vial into a prefilled syringe presentation.

PHOTO-STABILITY TESTS OF EPINEPHRINE

PREFILLED SYRINGES

Mitsubishi Gas Chemical

PHOTO-STABILITY TESTS OF EPINEPHRINE

Yoshiko Sakuma and Tomohiro Suzuki provide an overview of OXYCAPT multilayer vial and syringe, with a particular emphasis on the advantages of OXYCAPT as a container for adrenaline, as demonstrated by recent studies conducted by MGC.

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