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INDUSTRIALISATION

MEETING QUALITY DEMANDS THROUGH INTEGRATED PRODUCTS & SERVICES
INDUSTRIALISATION
Lars Keinicke Hansen
Stevanato Group
MEETING QUALITY DEMANDS THROUGH INTEGRATED PRODUCTS & SERVICES
Lars Keinicke Hansen; Chiara Mussoi and Odra Pinato describe how the streamlining of processes and harmonisation of products and services can better serve pharmaceutical companies. A case study highlights how a unique combination of expertise in automation and glass primary packaging benefited pharma giant Merck Serono in a recent project.
INTEGRATING DESIGN AND INDUSTRIALISATION TO OPTIMISE COST, QUALITY & TIME
INDUSTRIALISATION
Pete Evans
SMC Ltd
INTEGRATING DESIGN AND INDUSTRIALISATION TO OPTIMISE COST, QUALITY & TIME
Pete Evans and Meredith Canty explore how integrating design and industrialisation teams can optimise the cost, quality and time of developing a novel drug delivery system.
MEETING DEMAND BY BRINGING MANUFACTURING IN-HOUSE
INDUSTRIALISATION
Bentsi Algazi
Eitan Medical
MEETING DEMAND BY BRINGING MANUFACTURING IN-HOUSE
Bentsi Algazi and Anna Kalika-Rodin discuss the process of developing and implementing in-house production facilities at Sorrel Medical, including cleanroom facilities. The authors discuss the regulatory requirements involved, practical considerations of the design and construction, and the benefits the establishment of in-house facilities confers to Sorrel and its pharmaceutical partners.
APPLICATIONS OF DEEP LEARNING IN MEDICAL DEVICE MANUFACTURING
INDUSTRIALISATION
Frederick Gertz
SHL Medical
APPLICATIONS OF DEEP LEARNING IN MEDICAL DEVICE MANUFACTURING
Frederick Gertz and Gilbert Fluetsch look at how deep learning can be leveraged in a medical device manufacturing environment.
THE FUTURE OF SMART FILL-AND-FINISH
INDUSTRIALISATION
Diana Löber
SCHOTT Pharma
THE FUTURE OF SMART FILL-AND-FINISH
Diana Löber discusses new developments in digitised pharmaceutical manufacturing and the role SCHOTT’s Smart Containers can play in traceability along the entire value chain.
FORMULATION FLEXIBILITY WITH NEW ERA HPMC CAPSULES
GI/ORAL
Sanjay Powale
ACG
FORMULATION FLEXIBILITY WITH NEW ERA HPMC CAPSULES
Sanjay Powale, Anita Solanki and Dorene Almeida discuss the benefits of HPMC capsules in overcoming challenges faced by traditional gelatin capsules.
INTERVIEW WITH STEVEN KAUFMAN, STEVANATO & URI BARUCH, CDP
INTERVIEW
Steven Kaufman
Stevanato Group
INTERVIEW WITH STEVEN KAUFMAN, STEVANATO & URI BARUCH, CDP
Steven Kaufman and Uri Baruch discuss the recently announced collaboration between their two companies to accelerate the development of a new variable-dose, cartridge-based pen injector platform for diabetes.
WHICH IS THE BETTER TOXICITY TESTING STRATEGY FOR COMBINATION DEVICES?
EXPERT VIEW
Mark Turner
WHICH IS THE BETTER TOXICITY TESTING STRATEGY FOR COMBINATION DEVICES?
Mark Turner explores the issue of toxicity testing for combination devices and asks which is the better testing strategy – ISO 10993 or extractables and leachables?
APPLICATION OF CFD IN THE DEVELOPMENT OF A WEARABLE BOLUS INJECTOR
WEARABLES
Marcus Hall
APPLICATION OF CFD IN THE DEVELOPMENT OF A WEARABLE BOLUS INJECTOR
Marcus Hall, Björn Ullbrand and Claus Schmidt Møller describe the use of computational fluid dynamics (CFD) as the primary design and analysis tool in the development of a wearable bolus injector.
OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE
PREFILLED SYRINGES
Shota Arakawa
Mitsubishi Gas Chemical
OXYCAPT MULTILAYER PLASTIC VIAL AND SYRINGE
Shota Arakawa and Tomohiro Suzuki, discuss the benefits of the OXYCAPT™ multilayer plastic vial and syringe for the rapidly growing field of biologics and regenerative medicines.
CHOOSING THE RIGHT LABEL MATERIAL FOR PREFILLED SYRINGES
EXPERT VIEW
Jos van Noort
CHOOSING THE RIGHT LABEL MATERIAL FOR PREFILLED SYRINGES
Jos van Noort outlines some of the key factors that must be taken into consideration when selecting a label for prefillable syringes.
PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform
PREFILLED SYRINGES
Wolfgang Moersch
ZwickRoell
PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform
ZwickRoell offers a wide variety of standardised test fixtures for parenteral devices including, described here: testing prefilled syringes to ISO 11040-4, -6 & -8; testing of Luer/Luer lock connections; serial, parallel and fully automatic syringe testing; and traceable, tamper-proof test results.
FINDING THE RIGHT PACKAGING FOR BIOLOGIC DRUGS
PREFILLED SYRINGES
Christian Helbig
SCHOTT Pharma
FINDING THE RIGHT PACKAGING FOR BIOLOGIC DRUGS
Christian Helbig introduces a new 2.25 mL version of SCHOTT’s syriQ BioPure® prefillable syringes designed specifically for the biologics market and, developed in partnership with WL Gore, the world’s first silicone-free glass syringe system.
THE TRUSTED TABLET: A NEW LEVEL OF SUPPLY CHAIN SECURITY FROM MASS DIGITALISATION OF MEDICINES
CONNECTIVITY
Kelly Boyer
Colorcon
THE TRUSTED TABLET: A NEW LEVEL OF SUPPLY CHAIN SECURITY FROM MASS DIGITALISATION OF MEDICINES
Kelly Boyer, Trent Lund and Barry McDough describe a means of mass digitalising medicines to address the problem of illegal and unauthorised production of pharmaceutical products in a meaningful way.
A FLEXIBLE, MODULAR PLATFORM TO DISRUPT THE BLOCKBUSTER MANUFACTURING MODEL
EARLY INSIGHT
Nick Rollings
A FLEXIBLE, MODULAR PLATFORM TO DISRUPT THE BLOCKBUSTER MANUFACTURING MODEL
Nick Rollings, Colin Barker and Richard Vellacott discuss the drug delivery scenario in the advanced therapy (AT) era, examining how the current slow-moving blockbuster treatment model is making way for a fast-moving, patient-focused era of personalised medicine
MANUFACTURING DPIS: CASE STUDY OF IMA ADAPTA<sup>®</sup> WITH BOEHRINGER INGELHEIM SPIRIVA<sup>®</sup>
INDUSTRIALISATION
Rainer Bauer
IMA Group
MANUFACTURING DPIS: CASE STUDY OF IMA ADAPTA® WITH BOEHRINGER INGELHEIM SPIRIVA®
Pietro Piera  and Rainer Bauer investigate the optimal process parameters for low-dose dry powder inhalers achieved by dosator technology, presenting a case study in which IMA’s capsule filler, Adapta®, is used to fill Boehringer Ingelheim’s Spiriva® (tiotropium) dry powder inhaler.
HOW TO GAIN A FULL UNDERSTANDING OF POWDER FLOW PROPERTIES, AND THE BENEFITS OF DOING SO
RESPIRATORY
Dr Geoffroy Lumay
Granutools
HOW TO GAIN A FULL UNDERSTANDING OF POWDER FLOW PROPERTIES, AND THE BENEFITS OF DOING SO
Geoffroy Lumay, Naveen Mani Tripathi and Filip Francqui show how the association of three recently developed flow measurement techniques can be used to gain valuable insights into powder properties and characteristics.
LED-GENERATED UV FOR ADHESIVE CURING IN MEDICAL DEVICES
PREFILLED SYRINGES
Roland Lindner
sortimat
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
3P Innovation
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. 
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
ZwickRoell
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.
SHARING IS CARING: POLYMER SUPPLIERS AS MEDICAL DEVICE DEVELOPMENT PARTNERS
EXPERT VIEW
Manuel Scherer
SHARING IS CARING: POLYMER SUPPLIERS AS MEDICAL DEVICE DEVELOPMENT PARTNERS
Manuel Scherer looks at whether the advent of wearable injectors calls for a more collaborative approach between polymer suppliers and medical device developers.
PRIMARY PACKAGING FOR WEARABLE INJECTION DEVICES
EXPERT VIEW
Dominique Bauert
PRIMARY PACKAGING FOR WEARABLE INJECTION DEVICES
Dominique Bauert and Anil Kumar Busimi provide an overview of existing wearable injector solutions and new requirements, with a focus on the role of the primary packaging inside the devices.
SCALABLE ASSEMBLY SOLUTIONS – FULLY INTEGRATED, TRULY GLOBAL
WEARABLES
Rolf Rihs
Mikron Automation
SCALABLE ASSEMBLY SOLUTIONS – FULLY INTEGRATED, TRULY GLOBAL
Rolf Rihs and Jean-François Bauer look at how Mikron has specialised in flexible, modular assembly solutions that are easy to evolve during the different stages of a product lifecycle: from development through to fully automated, maximum-performance production.
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