Helen Simons and Stephanie Ward describe how the new EU Medical Devices Regulation will impact on “grandfathered” devices that were approved under old regulation and are currently on the market, but do not necessarily comply with current/updated regulatory standards, and explain the potential implications for device manufacturers.
Theresa Bankston looks at the advantages of using an integrated system for drug-device combination products. As well as avoiding problems such as breakage and incompatibility, integrated products can offer solutions at every interface between the drug, container and delivery device and save significant amounts of time and money.
Torsten Maschke has been Chief Executive of the Sealing Solutions division of Datwyler and a member of the group’s Executive Board since October 2016. Before joining Datwyler Group, he was responsible for the worldwide distribution of sealing and damping solutions for the automotive industry at Freudenberg Group (Weinheim, Germany).
Christoph Hammer discusses the financial reasoning behind the selection of packaging equipment, taking into account real current and potential future requirements (paying particular attention to Industry 4.0 concepts), and highlighting the advantages of taking a modular approach, such as the solutions offered by Dividella and its sister companies.
Needlestick injuries remain a serious concern for pharmaceutical companies involved in injectable drugs. Biocorp has been developing NewGuard™, an integrated passive safety device to tackle this problem. Throughout the development phase, Biocorp defined key elements to ensure NewGuard™ will not require unnecessary changes to be made to the PFS manufacturing process. Philippe Lesaulnier and Eric Dessertenne explain more.
Dick Molin highlights some of the hazards that arise through the use of traditional lubricious coatings in parenteral delivery devices. Particular focus is paid to the problems of protein aggregation and trace impurities leaching from elastomeric components before describing how the polymer Parylene, applied as a very thin coating using SCS’ unique deposition method, avoids them.
The limitations of using glass-based auto-injectors, such as contamination, and the need for delivering complex, viscous preparations, have led to a new approach that uses polymeric PDC technology instead. Jonathan Lawson, Jonathan Bradshaw and Susie White look at what polymeric PDCs can offer in making auto-injectors truly patient-centric.
Jean Vuillecard, Philippe Lesaulnier and Eric Dessertenne explain how, despite great innovations, adopting new syringe safety systems has always been a trade-off between safety and the cost of implementing new processes and introduce Biocorp's Newguard™, a new passive safety system integrated on prefilled syringes without such compromises being required.
William Cirillo and Christian Keller describe a simple add-on connected digital platform that can work with an existing delivery device. Digital health is an umbrella term that covers a lot of different applications of technology in the health industry. From wearable sensors and electronic health records to health apps, connected and digital solutions are becoming more accepted.
Ludwig Weibel and Hans Peter Manser ask, how can drug delivery systems help in patient compliance? And what are the challenges to be encountered with novel drugs filled in 1 mL long prefilled syringes? A novel and innovative approach is presented meeting the requirements of today’s and future drug applications.
Christoph Hammer explains how Dividella exclusively manufactures machines for packaging pharmaceutical products at its facility in Grabs, Switzerland. The focus is totally on the packaging of parenteral pharmaceuticals in Top-Load boxes. These sensitive products demand well thought-out packaging solutions.
Neil Fletcher provides a spring manufacturer’s perspective of how springs can be used in medical devices, and how a lengthy and extensive device development process affects normal custom and practice in our industry. The report focuses on spring technology and highlights some of the challenges that spring manufacturers face daily.
Prefilled syringes are becoming an increasingly attractive option for complex biotechnology products, not least because of the savings in product volume compared to vials. There is now a wide range of options to suit different requirements which can make product selection a challenge. Wendy looks at what advances are currently being made.