• The lessons we have learned to date
- Separating the science from the marketing hype
- Key insights from patients, clinicians, and drug development teams
• What value propositions matter and how should we design products and services to serve them?
- The unique value of device connectivity, approaches to behavioural change and digital partnerships
 

• Clinical trial packaging design. The key points of concept, differentiation and industrialization.
• Commercial packaging VS Clinical packaging: How to combine the Regulatory Requirements, manufacturing constraints and hospital/patient centricity.
• Solutions for quick and easy identification of clinical boxes.

• Smart objects in prefilled syringes that enable unit-level traceability and industry 4.0 in drug delivery manufacturing
• Open platforms as enablers for new technology throughout the drug-device ecosystem
• Technology partnerships with Pharma and suppliers to implement new technologies
• Intelligent applications to support patient benefits and digital healthcare
 

Container integrity is a major issue within the pharmaceutical supply chain to ensure product and patient safety. The presentation will highlight a new label and cap security concept that reliably seals the container to meet the danger of product tampering, while also helping to protect against glass breakage and surface contamination. To ensure smooth processability of the label and cap solution, new modular machine concepts will be introduced that fit into existing environments at the pharmaceutical manufacturer.

• Monitoring real-time production lines efficiency
• Optimizing performances and OEE
• Connecting serialization lines and any other equipment
• Improving resource planning and maintenance

Drug delivery devices have taken on increasing sophistication to meet the needs of increasingly tech savvy patients. At the same time, more and more regulatory requirements such as recent revisions to USP661.1 have raised the bar for suppliers in this increasingly competitive arena. This presentation will outline and present examples of how Covestro, a polycarbonate supplier to healthcare for over 50 years, innovates its materials portfolio for healthcare to meet these challenges.
• Key Polycarbonate material properties for new Drug Delivery Devices
• Changing needs and requirements for Drug Delivery Devices (e.g. USP661.1)
• Polycarbonate innovations for Global Drug Delivery Device Manufacturers
• Orienting Drug Delivery Materials toward Circular Economies and New Sustainability Requirements

The Healthcare Plastics Recycling Council (HPRC) is a private, technical consortium of industry peers across the healthcare, recycling, and waste management industries seeking to improve the recyclability of plastic products and packaging within healthcare. Founded in 2010, and made up of globally recognized members, HPRC engages in pioneering projects designed to help boost plastics recycling efforts in clinical settings of hospitals. Committed to continuous dialogue, HPRC explores ways to enhance the economics, efficiency, and ultimately the quality and quantity of healthcare plastics collected for recycling. In this presentation, you’ll hear about:
• The collaborative approach of HPRC
• Examples of HPRC project work
• Opportunities to get involved with HPRC in Europe
 

Single use auto-injectors are popular for self-administration as the users are not in direct contact with the syringe or drug pre-injection. They are simplified so it is easier to use as it is all prepared, requiring just a button press. This is particularly relevant to emergency situations.

The single use auto-injectors are disposed of in a sharps bin as medical waste, which is then incinerated. However, only the syringe is technically considered to be medical waste. Therefore more of the device than necessary is being discarded as medical waste, wasting resources and affecting the environment.

PA has developed a eco-friendly concept by
• Replacing standard materials with biocompatible/ biodegradable materials
• Separating auto-injector into medical and non-medical waste could make recycling an option

According to Investopedia, “A black swan is an extremely rare event with severe consequences. It cannot be predicted beforehand, though many claim it should be predictable after the fact.” According to Accenture, a playbook includes “process workflows, standard operating procedures, and cultural values that shape a consistent response—the play. A playbook reflects a plan,an approach or strategy defining predetermined responses worked out ahead of time.” In short, a playbook shows maneuvers that form the pieces and parts to getting something done – in this case, exiting PVC. Key strategic factors covered in this playbook: cost, time, regulatory risk.
• Banning PVC: A “Black Swan” event for pharmaceutical flexible packaging
• Machinery Play – maneuvers required for modifying or replacing packaging equipment for non-PVC materials
• Operations Play – maneuvers required at the operational level, including efficiency
• Regulatory Play – maneuvers of what has to be done to establish equivalence
• User Interface Play – maneuvers required to manage the impact of non-PVC structures on the user experience
• Observations for the future…

Two topics have been constantly keeping our medical device community busy, in particular in the drug injection field: how to offer a true device platform, usable across different drug families and therapeutic areas, combined with the discussion around value of data generated by connected devices. It is broadly accepted that a true device platform should enable to reduce development time and overall time-to-market, regulatory risk, costs and Capex. We believe that such platform should also be able to accompany a drug throughout its entire lifecycle, from early-stage clinical trial to lifecycle management of a mature drug product. In addition, gearing up such device platform with connectivity, sill today raises the question of the value of the generated data. The “lots-of-data-makes-it-all” approach may be an approach worth to try but does still not answer the question of the real value of generating data and information. We believe that focusing a connected solution, generating data, on a simple use case, such as clinical trials, may provide a faster response for a sustainable and proven value proposition for connected device solutions.

• STERIS is investing globally in growing their network of sterilization facilities.
• Additional E-beam capacity added in Malaysia and USA.
• X-ray processing to be available in the Netherlands, USA and south-east Asia.

Dry Powder Inhalers (DPIs) have long faced challenges in terms of the robustness of management of active packaging. Active pharmaceutical ingredients (API) delivered in capsule-based DPIs can be subject to moisture and oxygen causing degradation of the API and ultimately impacting patient therapeutic efficacy. Three-phase polymer technology offers unique protection from residual moisture and ingress through the package. This presentation will explore the application of Aptar’s proprietary three-phase polymer™ technology in managing headspace, moisture and oxygen. It will also review a case study on a reservoir DPI, utilizing all three-phase polymers.
 

The noise generated around reducing the carbon footprint of industrial products has grown from a local whisper to a global symphony, this growing commitment to our environment could now impact the future of our medicinal products. Inhaler devices have been subject to close environmental scrutiny before, resulting in the transition from CFC to HFA propellants in 2008 to combat the threat of ozone depletion. Today we face a new challenge of global warming. So, where are we today? Where do we need to be tomorrow? We will explore where next for MDIs & HFA propellants, review the alternatives available and discuss the opportunities and solutions for the future.