PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024

PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024 Posters

Poster Summary/Abstract Information
  • A User-preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal Injections

    Reza Abedian, PhD
    Reza Abedian, PhD
    Senior Medical Affairs Manager
    Gerresheimer
    Abstract
    This work focused on understanding the current practice of the intravitreal injections (IVIs) and existing challenges for both patients and healthcare professionals with the ultimate goal of developing a combination device concept for intravitreal injections. Using a systematic approach, an initial user preference study was initiated that incorporated an online survey designed and conducted with retinologists from the EU countries (n = 25), followed by in-person interviews with national and international KOLs (n = 5). Multiple feasibility studies were conducted with focus on the unmet needs of key users such as handling characteristics and accuracy of the injection volume focusing on potential device solutions to address these unmet needs. Finally, laboratory testing and user experience evaluation of device potential concepts were used to find the best fitting device concept for injections of a fixed dose (0.05 ml) into the eye. Both qualitative evaluation and statistical analysis were used to study significant differences between the results of injection with device and standard of care. Compared to the manual IVI procedure, an automated device has the potential to increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and expensive operating rooms.
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  • MediPhorum Drug Delivery Collaboration Community Presents a Collaborative Framework for Optimized Drug/Device Co-development

    Soroosh Bagheriasl, PhD
    Soroosh Bagheriasl, PhD
    Senior Account Manager
    MediPhorum
    Abstract

    The MediPhorum Drug Delivery community represents eleven global organizations from the BioPharma industry coming together to collaborate and share knowledge on combination products for drug delivery.

    The MediPhorum Drug Delivery community collaborates on a number of key topics that are vital for combination product development: Risk Management, Biocompatibility, Essential Performance Requirements, Human Factors and Regulatory considerations.
    The objective of this poster presentation is to convene subject matter experts and thought leaders from various collaborative groups to exchange insights and tackle challenges pertinent to drug-device co-development. The ultimate goal is to refine an optimized model for Drug/device co-development.

    The development of combination products demands a synergistic approach that spans pharmaceutical sciences, engineering, regulatory insights, and clinical research. Initiating device development at the Discovery/pre-clinical development stage (IND) is critical, with effective communication between drug and device teams being fundamental to success.

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  • Multiphysics Simulation of Needle Clogging in Pre-Filled Syringes

    Joseph M. Barakat, PhD
    Joseph M. Barakat, PhD
    Senior Engineer
    Veryst Engineering
    Abstract
    Needle clogging in prefilled syringes can impede drug product injection and negatively impact drug product quality. Computer simulations provide a useful tool to understand clogging mechanisms and elucidate design strategies to minimize or avoid clogging. In this talk, we present multiphysics simulations of clogging in needle syringes prefilled with a monoclonal antibody solution. We use these simulations to evaluate several putative clogging mechanisms, including: (1) fluid ingress into the needle and subsequent solvent evaporation leading to a dried solid plug, and (2) shear-induced jamming driven by rapid plunger compression. We study the impact of solution properties, needle diameter, barrel hub shape, and plunger speed on the onset of clogging. The effect of protein concentration on the solution viscosity is considered. Simulations such as these can offer insight into the critical material, geometric, and operational parameters that increase the probability of clogging, as well as a method to systematically triage drug product formulations based on their clogging probability. Based on these insights, we illustrate how simulations can be leveraged to effectively design prefilled syringes to minimize clogging probabilities for a given drug product formulation.
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  • Per- and Polyfluoroalkyl Substances (PFAS) in Primary Packaging and the Proposed ban in the European Union

    Taras T. Bredel
    Taras T. Bredel
    Business Development Manager
    Injecto
    Abstract

    In February 2023 a restriction proposal to the European Chemicals Agency (ECHA) was submitted by five member countries of the European Union proposing a substantial restriction under the Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH) regulation Annex XV for the use of all PFAS variants, thereby potentialy listing all PFASs as Substances of Very High Concern (SVHC).

    The poster will address the development of the proposal to restrict and the corresponding proposal options defining the transition and derogation periods if the restriction is approved by the EU commisions, how it may affect parenteral primary packaging and what options are there.

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  • Innovative Dual Chamber Blow Fill Seal (BFS) Injection System Development: A Collaborative Case Study by ApiJect and PSN Labs

    Mark Burchnall PE
    Mark Burchnall PE
    Engineering Director
    PSN Labs
    Abstract
    This collaborative case study presents the innovative development of a dual-chamber Blow Fill Seal (BFS) needle injection system by ApiJect and PSN Labs. Utilizing novel manufacturing techniques and product development methodologies, this project aims to redefine industry standards for BFS delivery systems. The design was completed through the utilization of rapid BFS prototyping, incorporation of computational modeling and simulation (CM&S) for evidence generation, risk-based thinking, early user studies, understanding material behavior, and development of novel test methods.
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  • Advancing Injection Force Modeling and Viscosity-Dependent Injectability Evaluation for Prefilled Syringes (PFS)

    Wei Chen, PhD
    Wei Chen, PhD
    Exec Director
    WuXi Biologics
    Abstract

    PFS development requires a comprehensive understanding of the forces involved in drug administration that affect dose accuracy, injection safety, and patient adherence. To better predict injection dynamics, we refined the mathematical model for injection force by integrating both hydrodynamic and frictional forces.

    In the improved model, we included drug viscosity properties (both Newtonian and Shear-thinning) and the syringe shape constant in the hydrodynamic force analysis, following the Hagen-Poiseuille law, and derived the friction force from empty barrels. The model also took into account the actual environmental temperatures during administration. Results highlighted the critical roles of the syringe shape constant and the rheological behavior of protein solutions in governing injection force dynamics.
    We considered the counter pressure generated by the tissue during actual administration to address the inaccuracies in current injection force evaluations conducted in air, especially when the viscosity of the injected drug solution is below 9.0 cP (injecting with 1 mL L PFS staked with 29G ½ inch needle).

    Finally, a simplified human factor study on injectability against viscosity was conducted, indicating that healthy adults were comfortable injecting medication with a viscosity of approximately 20 cP (1.0 mL in a 1 mL long PFS) within 15 seconds.

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  • Control Elements Gone Wild: Mastering Combination Product Requirements for a Product-specific CSS

    Ouissam Dahman
    Ouissam Dahman
    Risk Manager
    Boehringer Ingelheim
    Abstract

    The regulatory landscape requires the identification and assignment of several control elements when developing a drug device combination product (DDCP).

    Next to CQAs that are well established for drug products, primary functions (PFs) are required per ISO 11608-1, essential design outputs (EDOs) are required per ISO 13485:2016 and by 21 CFR 820.30, and essential performance requirements (EPRs) are used and required by the FDA. All these control elements aim for safety and efficacy and shall be declared for DDCPs.

    At Boehringer Ingelheim, we have established a process that allows us to derive these control elements based on risk management according to ISO 14971, in a systematic and traceable approach. The definition of Critical Functions during the identification of Hazards allows to identify Primary Functions in a very early project stage supporting a control element-directed development.

    Furthermore, we created the document “Device Control Plan” that gives an overview on critical design-related aspects. It documents which control elements are relevant for the product-specific CSS, keeping the CSS lean.

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  • Sustainable Design for Healthcare Devices: Pathways Toward Net Zero

    William J. Davies
    William J. Davies
    Design Consultant
    Shore Group
    Abstract

    An engaging infographic format identifying sustainable design principles, theories, practices and technologies applicable to medical and pharmaceutical devices, that can be deployed to make significant reductions in device or system footprints, down to net zero. Circularity will be identified as the primary objective for sustainable design. The poster will highlight design opportunities in materials, manufacturing, transport, use, and end-of-life phases that facilitate emissions reduction and enable steps to be taken toward full or partial circularity. This will include the following categories:

    • Sustainable design principles, including resource reduction, behavioural change, and system opportunities such as product-as-a-service business models.
    • Technical considerations, such as manufacturing, packaging, electronics, and transport.
    • Opportunities for component or module re-use, in preference to recycling or other waste streams.
    • Materials, looking at conventional and alternative materials, and highlighting key meanings in sustainability claims such as mass-balance or recycled content.
    • Tools and future technologies such as Life Cycle Analysis and lifecycle tracking through Digital Product Passports or Unique Device Identifiers.
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  • What is the Risk of Losing Container Closure Integrity of Syringes at Cryogenic Temperatures?

    Bas de Oude, MSc
    Bas de Oude, MSc
    R&D Lab Researcher
    LIGHTHOUSE Instruments
    Abstract
    As an increasing number of gene and cell therapies get closer to the commercial stage, the need for developing finished product container closure systems (CCS) that can resist the freezing, prolonged storage and thawing from cryogenic temperatures has become more critical. Recent studies have clearly demonstrated that the risk of ultracold temperatures to container closure integrity (CCI) can be high. Temporary leaks can be created while freezing, during ultracold storage and transport, and when thawing from cryogenic to room temperatures triggered by the fact that the individual components of a container closure system (CCS) each react differently to the exposed temperatures. The potential for failure of CCI is packaging component- and process-dependent, including but not limited to, the properties of the materials (e.g. polymer, glass, and rubber), their fit and interaction, as well as the freezing and thawing rates to and from temperatures
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  • Dissecting USP 382: Elastomeric Closure Functionality in Pre-Filled Syringe Delivery Systems/Requirements for Container Closure Integrity

    In the intricate landscape of pharmaceutical packaging, elastomeric closures emerge as indispensable keystones, playing a pivotal role in fortifying the integrity and efficacy of injectable drug products. Beyond mere containment, these closures exert influence over critical aspects such as administration precision, maintenance of sterility, and the formidable prevention of product contamination.

    For decades, the U.S. Pharmacopeia (USP) has been the guiding beacon, offering insights into the evaluation of sterile product packaging integrity through USP 1207 Package Integrity Evaluation – Sterile Products. Recently, however, the pharmaceutical landscape has witnessed a significant paradigm shift with the revisions encapsulated in USP 382, a focused directive set to reshape industry standards, particularly with respect to products employing elastomeric closures.

    Understanding proper CCI method selection for PFS, risk assessment, and component compatibility lead to packaging success.

    Michael A. Devito
    Michael A. Devito
    Regional Sales Manager, Life Sciences
    PTI
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  • Characterization of Pre-filled Syringe Container Closure Integrity in Deep-Cold Storage Conditions

    Sonia Dragulin-Otto, MSc
    Sonia Dragulin-Otto, MSc
    Senior Scientist
    AstraZeneca
    Abstract

    Most people typically associate Human Factors with conducting a one-time simulated use study to inform the design of combination products or medical devices and to validate their safety and effectiveness. However, Human Factors encompasses more than that. When used in a longitudinal study, Human Factors can help evaluate product use over time, uncovering insights about user needs that might have been overlooked in a conventional one-time simulated use study.

    In the context of understanding and improving user needs and adherence  when using injectables, incorporating digital features into these products seems ideal. However, simply adding digital features without understanding user needs over time is insufficient to inform product design. This study examined both one-time simulated and weekly use over a period of four weeks with various digital features to support adherence in autoinjector use, and aimed to understand feature preferences and current effective adherence strategies.

    The study also provides guidance for designing device and digital features, addressing both immediate and potential prolonged use issues identified during the simulated use and longitudinal phase.

    Combining simulated use studies with longitudinal Human Factors research, allows for a comprehensive understanding of combination product usage, digital features impact patient adherence, and user needs.

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  • Optimizing Prefillable Polymer Syringe Nest Design for Enhanced Fill-and-Finish

    Marco Eller
    Marco Eller
    Product Manager
    Bausch+Stroebel SE +Co.KG
    Abstract

    Manufacturers are increasingly challenged to meet the demand for high-speed and large scale production and the need for containers that can be filled quickly and efficiently, while reducing costs without compromising on quality or regulatory compliance. In addition, with increasing regulatory pressure, companies need to find ways to reduce CO2 emissions and minimize waste management cost. Therefore Bausch+Ströbel SE+Co. KG partnered with SCHOTT Pharma for gamechanging transformations to achieve operational excellence and sustainability, while maintaining the production of high quality drugs. 

    With the new 10 x 16 TOPPAC® Nest 160 our customers operational efficiency and sustainability is unlocked by increasing efficiency as much as 60%. Thanks to the optimized packing density 67% more syringes per nest can be processed in comparison to the conventional 10 x 10 Nest 100. This makes the Nest 160 in combination with the SFM5072 filling and closing machine from Bausch+Ströbel ideal for high-speed production of vaccines, diluents or dermal fillers, without compromising on quality or sterility and with 100% identical inspection.

    Manufacturers can retrofit their existing and proven processing B+S nest filler SFM5072 and benefit from a 60% increase in output, higher machine availability, a reduction in waste and all with the same machine footprint.

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  • Developing Coated Large Volume Plungers for Auto-injector and Wearable Devices

    Paolo Ferrigno
    Paolo Ferrigno
    Product Manager, Prefilled Syringes & Cartridges
    Datwyler
    Abstract

    Large-volume auto-injectors and wearable devices exceeding 2.25ml play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administration via subcutaneous (SC) injection.

    These devices are pivotal across various medical fields such as oncology, immunology, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics.

    Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety.

    In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration.

    We will showcase our journey in conceptualizing and refining these new plungers, as well as evaluating their performance throughout the entire value chain to the patient.

    Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product.

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  • Nitrogen Dioxide Sterilization is a new State-of-the-art Sterilization Technology to control Contamination Risks From your Prefilled Devices and Combination Drug Products.

    Annick Gillet
    Annick Gillet
    Technical Director Gas Pharma
    Sterigenics
    Abstract
    Prefilled Devices and Combination Drug Products, particularly those with integrated fluid paths or for specific Therapeutic Areas like Ophthalmology, may require final sterilization. Nitrogen Dioxide is a ground breaking novel sterilization technology designed to suit sensitive Prefilled Devices and Combination Drug products. This innovative sterilization process runs at ambient temperature and uses very low sterilant concentration. A SAL ≤10-6 is achieved in a few minutes of exposure, making this new technology highly efficient, without penetrating the drug reservoir.  A case study will be shared, illustrating a validated process. This new modality will provide manufacturers with a new gas alternative to consider for their drug product to help ensure product safety for use in patients.
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  • Application of Modeling as a Tool for Early Derisking of Parenteral Delivery, from the Primary Container to the Tissue

    Ludovic Gil, PhD
    Ludovic Gil, PhD
    Senior R&D Engineer
    BD
    Abstract
    In silico modeling of subcutaneous injections is a promising tool to derisk and optimize the development of injections systems and improve preliminary understanding of the injectability of drugs. Such modeling can be leveraged early in development, prior to pre-clinical studies, to reduce testing burden and effectively predict aspects such as the time and forces required for full dose delivery into tissue and the tissue-injectate-device interactions. In this talk, we will describe the three main in silico pillars (primary container, injection device, and tissue) that are necessary to simulate a parenteral injection. We will showcase how their modeling can be combined and applied to various delivery systems and injection conditions to enable appropriate systems and parameters selection to achieve desired performance. Case studies of viscous drugs in PFS/AI and wearable injection systems with non-rigid component properties will be presented to highlight the theoretical treatment of interfaces, the critical inputs required to achieve accurate predictions, the insights gained, and the good agreement between model predictions and experimental results. The ideal application of such modeling along the drug/device development journey to enable decision-making and stage-appropriate investments will also be discussed, along with the limitations of modeling tools and their application.
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  • Break Loose Force and Glide Force Evaluation of Various Container Closure System Combinations

    Jeremy Guo, PhD
    Jeremy Guo, PhD
    Senior vice president
    WuXi Biologics
    Abstract
    A comprehensive evaluation of break-loose force & glide force (BLGF) was conducted on 1 ml long (L) & 2.25 ml empty syringes from 3 vendors in combination with 5 plunger stoppers from different vendors.  Fifteen container closure system (CCS) combinations for 1 mL long L (L) and for 2.25 mL syringe were assessed respectively. Potential factors that could impact BLGF were investigated, including the measurement of silicone oil content and distribution withinof the tested syringes. The results indicated that variation in silicone oil levels did not affect the BLGF performance of the CCSs. However, the properties of the plunger stoppers played a dominant role in BLGF performance, e.g., the, most notably the stopper design. These comparisons of different CCS combinations provide valuable insights into the basic BLGF performance of syringes and plunger stoppers from different vendors.
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  • Innovation Phase Strategies to Ensure a Smooth Transition from Concept to Production Design

    Thomas James
    Thomas James
    Lead Mechanical Engineer
    Key Tech
    Abstract

    Transitioning from concept to production design in drug delivery devices requires meticulous planning and execution. This poster explores strategies crucial for this transition for implementation during the innovation phases. Before moving to production design, critical-to-function parameters must be thoroughly explored for feasibility and optimization. Collaboration with critical suppliers is essential to identify component performance and reliability boundaries, particularly in the context of modern electromechanical devices in drug delivery.

    Beyond force specifications and injection stroke lengths, understanding the usability features of device presentation is vital during the innovation phase. Secondary packaging solutions, instructions for use, and quick reference guides undergo design/build/test cycles to define successful product presentation aligning with clinical setting, strategic vision, and user expectations. Clarifying these characteristics before the transfer-to-production phase facilitates efficient and informed decision-making. Micro case studies from a host of customer programs are included to illustrate the critical scaffolding needed to navigate this transition.

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  • Large Volume Injections in Göttingen Minipigs

    Andres Jensen, DVM
    Andres Jensen, DVM
    Study Director
    Ellegaard Göttingen Minipigs A/S
    Abstract
    The Göttingen Minipig was investigated as a model for large volume injections. Various volumes and flowrates were tested at different injection sites. Backpressure was determined using a syringe pump fitted with a load sensor and the acute resorption rate was determined using 3D image analysis of the induration.
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  • How the use of Artificial Intelligence in Research and Development can help to drive Innovation in Drug Combination Products

    Diana Koschel
    Diana Koschel
    Senior Manager R&D
    BD
    Abstract

    Artificial Intelligence (AI) is increasingly playing a pivotal role in research and development (R&D). BD is focused on applying AI to de-risk combination product development for our pharma partners. Two examples using AI in BD are highlighted:

    • Deep learning for Sub Visible Particulate (SVP) analysis:
      Characterization of SVP in pharmaceutical containers is difficult due to their diverse origins.  Their morphology and size vary significantly and are assessed by flow imaging techniques. The accurate identification of SVP is challenging yet essential to derisk combination product development of biologics. Through a partnership with IBISC and SATT, we are using AI to develop a new model that combines existing methods to identify subvisible particles. The goal is to increase confidence in distinguishing between protein aggregation and other subvisible particles.
    • Knowledge Capitalization:
      Knowledge is an invaluable asset, particularly in the realm of innovation in R&D.  The capitalization of tacit knowledge, powered by AI, not only fuels our innovation engine but could also provide benefits in terms of reduced innovation lead time and effective risk mitigation. Our commitment to knowledge capitalization and rapid innovation aims to translate into high customer satisfaction.
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  • Visual Impairment Affordances Can Benefit All Users

    Lisa Lacouette-Ward, MS
    Lisa Lacouette-Ward, MS
    Senior Specialist, Regulatory Affairs & Human Factors
    West Pharmaceutical Services
    Abstract
    Increasing patient access to safe, effective devices remains a top priority for global regulatory bodies, including the FDA1.  Expanding access is multi-faceted and includes designing injection devices that can be used at home and by diverse patient populations. Interface design of injection devices and accompanying materials such as labels and Instructions for Use (IFU) should aim to serve the most diverse user population allowable. When accommodations for impaired users do not impede use or increase risk for intended populations, efforts should include such affordances. Human factors design principles, together with ISO 11608-7:2016 and ADA guidelines, can inspire medical device manufacturers to incorporate features increasing usability for the visually impaired. The estimated 12.5 million US adults aged 40+ currently living with a visual impairment are expected to increase by 118% by 20502. IFU design that incorporates optimal font choice and size, contrast, color, and whitespace can increase accessibility. Inclusivity in design could facilitate patient device use at home, leading to increased adherence to treatment regimens, reduced need for hospital/clinic visits, reduced exposure for immunocompromised patients, and increased patient and healthcare professional satisfaction. Human factors usability testing and validation of interfaces cultivated with inclusivity can have far reaching benefits for use.
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  • Functionality of Glass Pre-Fillable Syringes at -40°C Storage: Data on the Glass Barrel and Sealing Interfaces

    Charlotte Leconte Ostrowski
    Charlotte Leconte Ostrowski
    Global Product Portfolio Manager PFS
    NiproPharmaPackaging International
    Abstract

    mRNA technology represents a significant breakthrough in drug development. Several mRNA- based vaccines candidates are in the pipeline for the prevention of influenza, respiratory syncytial virus, cancer, and other diseases.

    When glass pre-fillable syringes have been developed, typically tests have not been carried out at temperature below 0°C. Rapid temperature changes can cause glass to expand or contract suddenly, leading to potential breakage. Additionally, cold temperatures can affect the flexibility and movement of the plunger, potentially causing functionality concerns and impact container closure integrity. Consideration must be taken by using rubber materials designed to maintain flexibility at low temperatures.
    With this poster, we provide new data on low temperature storage and demonstrate that the key attributes for functionality of glass pre-fillable syringes have been met. Focus is on the behaviour of the glass barrel and the sealing interfaces.

    Authors:

    Luca Durante, Technical Support Engineer, Nipro PharmaPackaging International
    Charlotte Leconte-Ostrowski, Product Portfolio Manager PFS, Nipro PharmaPackaging International

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  • Navigating Packaging Challenges for Drugs and Injection Devices

    Ling	Lu, MS
    Ling Lu, MS
    Associate Director, Quality Engineering, Combination Products Packaging
    Bristol-Myers Squibb
    Abstract
    This presentation explores the critical role of packaging ensuring quality, usability, safety, efficacy/effectiveness and regulatory compliance of drug and injection device products throughout their lifecycle. It highlights the intricacies of regulations associated with drug and device packaging, referencing FDA guidance of minimizing medication error, and applying human factors engineering principles. It outlines the challenges of implementing these guidelines, applying design controls, risk management, human factors and control strategy principles in the development and lifecycle management. Additionally, this session discusses a holistic risk-driven approach with practical considerations for combination product packaging.
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  • Insights into Industry Perspectives, Preferences, and Decision-making Factors on Large Volume Subcutaneous Drug Delivery

    Allison Mack, APRN, MSN
    Allison Mack, APRN, MSN
    Associate Director, Medical Education
    Enable Injections
    Abstract
    This survey study was conducted among experts in clinical development, medical affairs, and commercial roles within the pharmaceutical industry, examining perceptions, preferences, and decision-making factors concerning large volume subcutaneous (SC) drug delivery. It challenges the conventional belief that SC delivery is limited to volumes of 2-3 mL without permeation enhancers, aiming to reshape industry paradigms. The research explores device format selection, the impact of permeation enhancers on bioavailability, and how industry practices influence experiences for patients and healthcare providers. By analyzing responses on the prioritization of delivery attributes—such as speed, ease of use, and patient and healthcare provider preferences—and the prevalence of different device formats, the study aims to clarify the current landscape. It also investigates motivations behind specific development paths and the role of historical device usage in future development. In a field with limited comprehensive public data, the findings are expected to inform a more nuanced approach to SC drug formulation and device selection, advocating for innovations that balance efficacy with patient comfort and streamline care in pharmaceutical development. This research represents a crucial step towards evolving industry standards and improving patient outcomes in SC therapy.
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  • Physical and Physicochemical Interactions Between Pre-Filled Syringe Components and Drug Products

    Steven J. Malbon
    Steven J. Malbon
    Combination & Physical Devices Manager
    Medical Engineering Technologies Ltd
    Abstract
    This poster explores the physical and physicochemical interactions occurring between the components of prefilled syringes and drug products. Understanding these interactions is crucial for ensuring any drug formulations delivered via pre-filled syringes don’t have an adverse effect on the syringe performance. Various factors such as material compatibility, extractable and leachables, and device design can influence these interactions. This poster highlights the importance of characterising and optimising pre-filled syringe components to mitigate potential adverse effects on drug product quality and patient health.
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  • Impact of VHP Sterilization as Established Category A Modality

    Juha P. Mattila, MEng
    Juha P. Mattila, MEng
    Senior Manager, Technical Services
    STERIS Life Sciences
    Abstract
    In January 8, 2024 FDA announced Vaporized Hydrogen Peroxide (VHP or VH2O2) to Established Category A sterilization methods, that include steam, radiation and ethylene oxide modalities. This significant move in the regulatory field of medical device sterilization was preceded by the publication of ISO 22441:2022, the process validation standard specific to VHP sterilization - and FDA adopting ISO 22441 in 2023. This will further accelerate the biopharmaceutical and medical device industries in adopting VHP as an equally viable option to the conventional sterilization methods. In the biopharmaceutical manufacturing context this will help the pre-filled syringe / combination device manufacturers in improving patient safety by having the option of VHP terminal sterilization of finished product that includes temperature or radiation sensitive injectable drug products.
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  • Bridging the Gap – Ensuring Digital End-to-End PFS Integrity via an RFID-Based Seal: Holistic Digitalization of Inventory Management and Diversion Prevention of Hospital Drugs

    Sebastian Muenscher
    Sebastian Muenscher
    Product Manager RFID/NFC Solutions
    Schreiner MediPharm
    Abstract

    RFID technology is mainstream in retail where apparel is tracked and inventory is managed with digital reader systems. All items at e.g. Walmart, Nordstrom and H&M are equipped with an RFID tag. Thus, warehouse managers and sales staff have full visibility on the movement and availability of items. The pharma industry is starting to follow this trend.

    Pre-filled syringes equipped with RFID are gaining importance in US hospitals. Administration of drugs for use in the operating room is enormously facilitated with RFID. Inventory, recall and lot/expiry management are digitized, easy and accurate. Smart cabinets can read and document every step in the supply chain and keep track of drugs on item level. Another advantage is the efficient return process of unused drugs to inventory.

    But how to prove that a syringe has not been opened while being removed from inventory? There is obviously a critical gap in the automated process as manual intervention is required to check PFS integrity. This gap can now be closed with a digital seal assuring that a life-saving data point is tracked though the whole chain of use. This is not only crucial for patient safety but also to monitor diversion and misuse of drugs.

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  • Stability Evaluation of Injection Device Functionality Including Polymer-Based Pre-Filled Syringe with Biologics

    Masaki Muto
    Masaki Muto
    Researcher
    Chugai Pharmaceutical Co., Ltd.
    Abstract
    Prefilled syringe and autoinjector contribute to patient convenience for self-administer biologics via subcutaneous administration. These injection devices are constructed with various materials. The properties of constituent materials impacted on the functional properties of injection devices. The functional performance is changed by the degradation rate of the constituent materials performance over time. This study primarily focuses on the chemical degradation process, which potentially exhibits environmentally dependent effects. Within the realm of injection device development, a procedure termed the '10-degree rule' has been traditionally applied to the Arrhenius model, grounded in collision theory, to predict the shelf life of these devices. However, the universality of this approach raises concerns, as it may not be applicable to all materials, particularly those in direct contact with drug solutions. The barrel interior of prefilled syringes is typically coated with silicone oil for lubrication to aid plunger movement at the time of administration. Actually, data indicated that the physical state of the siliconized surface and lubrication function with cyclic olefin polymer (COP) prefilled syringe (PFS) can change over time in contact with biologics drug product. We evaluate statistical model such as the 10-degree rule for the functional degradation based on the obtained data.
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  • A Design Tool and Methodology for Understanding Patients’ Capabilities in Medicine Development

    Christian Noone
    Christian Noone
    Inclusive Designer
    GSK
    Abstract

    The patient’s voice is often missing in medicine and device development processes. This poster presents our methodology for developing a deeper understanding the capabilities of patients across different disease areas.  We aim to listen and ensure the patients’ voices are at the forefront of the decisions we make—from early research through to marketed products.

    An important component in the development of the voice of the patient is our User Capabilities methodology and tools which were developed by GSK’s Inclusive Design team in collaboration with the University of Cambridge and an external research consultancy. Through direct engagement with patients, our survey tool presents a suite of questions that yield the data building blocks for analysis and development of patient capability profiles. This provides a clear picture of the capability loss patients experience due to their health conditions, and highlights aspects that will require particular attention in research and development processes to ensure that exclusion from the use of our products is minimized.

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  • Secure LCM during Development

    Khushbu Patel, MS
    Khushbu Patel, MS
    Senior Device Engineer
    Pfizer
    Abstract
    Combination product development at a primarily pharmaceutical company is full of challenges. What is often overlooked is not only does the combination product need to be developed in accordance to design controls, but that device must also be maintained through its life cycle. A typical combination product spends only about 20% of its total life in development and spends a whopping 80% of its total life in life cycle management. Considering, to ensure successful life cycle management it is important to begin planning and strategizing LCM activities during the development phase. A major impediment to LCM activities are streamlined strategies executed during the development phase to support expedited timelines. As development timelines become shorter and shorter, teams look for areas to save time and resourcing and the verification and validation segments often take the biggest hit. An effective streamlined strategies should seek not only to prepare a product for submission, but also sustain once that product is on market.
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  • EU GMP Annex 1 and Its Impact On Manufacturing and Processing of Primary Packaging Components

    Alison Phillips, PhD
    Alison Phillips, PhD
    Technical and Scientific Expert
    Datwyler
    Abstract
    This poster aims to highlight the importance of EU GMP Annex 1 as it relates to manufacturing and processing of primary packaging components. Annex 1 provides general guidance for the manufacture of sterile products, using principles of Quality Risk Management (QRM) to ensure prevention of microbial, particulate, and endotoxin/pyrogen contamination in the final product. A key addition to the new Annex 1 is the focus on a Contamination Control Strategy (CCS), with the ultimate goal of preventing contamination risks. A spotlight is cast on the quality of primary packaging components with importance placed on their design, manufacture, and selection. Manufacturers of primary packaging components can make significant contribution in the CCS of drug manufacturers. Datwyler’s most advanced manufacturing standard, FirstLine®, is especially designed to address contamination risks by the manufacture of rubber parenteral packaging components with ultra-modern cleanroom technology, automation, and validated washing processes. Impact from these process innovations on the quality of elastomeric components will be shared.
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  • Strategies for Successful Design Verification

    Sharlene Phillips
    Sharlene Phillips
    Head of Device Testing
    Team Consulting
    Abstract

    Design verification is often thought about far too late in device development, leading to a compressed timeline to achieve a successful outcome, as well as the potential for costly late-stage design iterations. It is all too easy during pre-verification activities to underestimate the time and costs that go into test method development and validation, as well as the number of samples that are needed and the implications in terms of manufacturing capabilities.

    Since 1997, the FDA ‘Design Control Guidance for Medical Device Manufacturers’ has offered a waterfall diagram which shows how design controls can be applied to any product development. This arguably over-simplified representation of design controls has since been adapted by device manufacturers to meet their specific requirements, resulting in a variety of “out of the box” approaches to design verification thinking.

    This paper will highlight some of the most effective “out of the box” thinking for design verification, discussing how early influence and pre-verification planning can help to de-risk the verification phase and help to save time and costs in the long run.

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  • SKAN ebeam

    Merritt K. Postma
    Merritt K. Postma
    Sales Manager Director
    SKAN US, Inc.
    Abstract

    The SKAN ebeam is designed to transfer pre-sterilised tubs with RTU components like syringes, vials, and cartridges into an isolator filling line. It is a safe surface sterilisation and transfer system for high-speed sterile pharma production, but also for C(D)MOs who seek a flexible and efficient transfer solution for different products and container sizes. 2”, 3”, and 4” tubs can be processed with only minor adjustments.

    The ebeam tunnel is not only available as part of new installations but can be integrated into existing isolator filling lines. This does not only offer you state-of-the-art technology with a small footprint, but also decreases your operational expenditure (OPEX) in the long run.

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  • Comparison of Direct and Indirect Container Closure Integrity (CCI) Testing Methods for Autoinjectors

    Steven Ren, PhD
    Steven Ren, PhD
    Senior Director
    WuXi Biologics US
    Abstract
    With the increasing prevalence of autoinjectors for self-administration of pharmaceuticals, ensuring container closure integrity (CCI) is paramount for maintaining drug sterility and efficacy. Traditional CCI testing methods, while established within the pharmaceutical industry, have not been extensively validated for their applicability and reliability on the complex structures of autoinjectors. This study aims to fill this gap by conducting a comprehensive comparison of two commonly used CCI testing methods when applied to autoinjectors. Through rigorous laboratory testing, we have demonstrated that these methods can be effectively adapted to assess the integrity of autoinjectors, providing a reliable means to ensure product safety throughout their lifecycle. Although the two methods are equally effective, each has its own set of advantages and disadvantages when considering other aspects. Our findings not only confirm the practicality of these methods for autoinjector evaluation but also offer valuable insights for manufacturers in selecting appropriate CCI testing strategies to comply with regulatory standards and safeguard patient health.
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  • Optimizing the Design of Combination Devices Operated by Individuals with Hand Impairments Through Human Factors/User Experience

    Joseph Reynolds, MS
    Joseph Reynolds, MS
    Director of UX/HF
    Noble International, LLC
    Abstract

    Designing combination devices for individuals with hand impairments requires designers to give great care to the accessibility and user experience of the product; dexterity, precision, control, and comfort — without them, no combination device design is a success. Ergonomic design is a strategy whereby all decisions made throughout the development process are considered through the lens of the user.

    Five key human factors to consider when designing a combination device that delivers a drug for people with hand impairments are as follows:

    1. The varying sizes, shapes, and capabilities among people’s hands.
    2. The design of combination devices and their relation to prevalent diseases.
    3. The transition from a dexterous multilateral grip to a clamping pincer grip.
    4. The hands’ pruning, with skin becoming translucent and prone to tearing.
    5. The discrepancies between patient-reported behaviors and observed actions.

    Hand impairments significantly alter grasping strategies and underscores the urgency of user-centric design. Understanding nuances between people with hand impairments is key to creating world-class ergonomic designs; by prioritizing user experience and observing real behaviors, designers can create ergonomic solutions tailored to the unique needs of patients with hand impairments.

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  • Container Closure Integrity Testing Strategy for Drug-Led Combination Products: A Practical Approach

    Jennifer M. Roark
    Jennifer M. Roark
    Technology Manager, Container Closure Integrity
    West Pharmaceutical Services
    Abstract
    Drug-led combination products offer patients the ability to self-administer treatments in the comfort of their own homes rather than at the clinic, driving the rapid growth rate predicted for these products over the next decade.  Regulatory authorities require demonstration of container closure integrity (CCI) for marketed drug products.  For drug-led combination products such as autoinjectors and pen injectors, determining CCI for the fully assembled device continues to be challenging due to limitations with the CCI technologies commercially available.  However, a stepwise approach to establishing CCI throughout the product life cycle can generate the data required to show that the product is safe, effective, and sterile through expiry and use.  Incorporating a Quality by Design (QbD) approach and a holistic in-process control strategy for CCI during product development and manufacturing can further mitigate the risk for CCI failures.
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  • Container Closure Integrity Test of OXYCAPT Multilayer Plastic Vial with Dry Ice at -80℃

    Yoshiko Sakuma
    Yoshiko Sakuma
    Researcher
    Mitsubishi Gas Chemical Company, Inc.
    Abstract
    The state-of-the-art drugs such as cell & gene therapy products are usually stored at deep cold temperature and often transported with dry ices. As the glass transition temperature of rubber is around -65℃ and the coefficient of thermal expansion is much different from the glass, it is important to choose the proper vials and rubbers in terms of container closure integrity (CCI). Instead of glass vials, COP vials are often used for such drugs recently to achieve good CCI, but we have found CO2 gasses eventually permeate into the COP vials after thawing process. OXYCAPT Multilayer Plastic Vial has excellent CO2 barrier as well as O2 barrier. Thanks to its excellent barrier properties, it can prevent CO2 gas ingress into the vials even after freezing and thawing process. We can show some successful results of CCI at -80 & -180℃ and CO2 barrier through the poster presentation.
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  • Dual Sourcing of Primary Packaging Components in Biopharma Manufacturing: A Case Study

    Tim Schultz, MBA
    Tim Schultz, MBA
    Associate Director
    Merck & Co., Inc.
    Abstract
    The biopharmaceutical industry has weathered multiple challenges over the past four years.  One of the major pressure points that manufacturers of parenteral products have had to overcome is supply chain issues--namely with primary packaging components.  Biopharma manufacturers must consistently act and react to such market pressures.  This poster will discuss how our company has challenged some of the "status quo" in the sterile primary packaging component space;  in particular, we will discuss how we have revised our governance system to address bringing sterile products to market in ways that can be more nimble and effective--including dual-sourcing of suppliers of syringes, vials, and elastomeric closures--ultimately bringing life-saving medicines and vaccines to our patients faster and more reliably.
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  • Addressing the Challenges of Highly Viscous Formulations Using a Needle-Free Technology

    Arjun S. Sree Manoj, MEng
    Arjun S. Sree Manoj, MEng
    Staff Bio-Medical Engineer
    Portal Instruments
    Abstract

    Extended injection durations and a fear of needles are common hurdles encountered by patients with needle-based injection therapies. The use of highly viscous formulations further exacerbates these challenges. To address these issues, we present an alternative method: a needle-free drug delivery system called PRIME. Here, we showcase a series of comprehensive studies assessing PRIME’s capabilities in terms of viscous ejection and injection durations in comparison to an autoinjector and a needle & syringe. We demonstrate the performance and translatability of jet injector technology from benchtop air ejections to ex-vivo porcine tissue injections.

    Using various concentrations of polyethylene glycol, we were able to simulate the patient experience of injecting medications with a range of viscosities from cold storage to room temperature. 1 mL ejection durations in air and injection performance into porcine ex-vivo tissue were assessed. Results demonstrated the ability of PRIME to consistently eject and inject low to high viscosity fluids with a 0.3 s duration. This injection performance was compared to an autoinjector with ejection durations of 1-2 min and needle & syringe injection durations up to ~25 s. An analysis of injection deposition in tissue revealed no significant differences between PRIME and the needle & syringe.

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  • Insight into the Design of Optimal Extractable and Leachable Studies for Regulatory Compliance and Accelerated Drug Development

    Ashley Stanoszek
    Ashley Stanoszek
    Extractables & Leachables Lead
    Gateway Analytical
    Abstract

    Every New Drug Application must include an extractables and leachables study to demonstrate the drug is safe. Several guidance and recommendations documents provide insight on how to perform these analyses and which methods to use, but as each drug combination product is unique, Pharma manufacturers must adapt to the requirements of their drug.

    In this poster, we dwell into the techniques that are most appropriate to perform a robust extractables study, the adaptation required for addressing specific drug storage conditions, choice of solvent and the definition of the Analytical Evaluation Threshold (AET) for subsequent leachables analysis. We describe how to perform semi-quantitative and quantitative studies while allowing for identification of the leached compounds, to provide pharma partners with a complete dataset that demonstrates the drug’s safety while supporting regulatory filing.

    We also present a case demonstrating how extractables studies can be designed by components suppliers without having prior information on the final drug products while ensuring it is appropriate for regulatory filing. When combined with simulated leachables studies, such approaches can greatly support pharma partners in anticipating the result of their actual leachable studies and support them in choosing the most appropriate closure solution for their drug.

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  • Aseptic Transfers in the Light of the new Annex 1

    Claudio Stempfle
    Claudio Stempfle
    Technical Sales Manager
    groninger & co. gmbh
    Abstract
    The new EudraLex Annex 1 describes very prescisly the requirements how to transfer materials from a lower grade to the Grade A area with a special focus on Contamination Control. With the rise of of RTU fill and finish lines the transfer methods of these ready to use (RTU) primary containers such as syringes, vials and cartrdiges gets a new focus. This presentation will highlight and compare in detail the operation, sterilty and validation prinicple of the major transfer technologies such as NTT, E-Beam, H2O2, Pulsed Light Decontamination, Plasma Decontamination and will put them into the light of the new Annex 1 requirements. In addition to the transfers of RTU containers the presentation will also touch upon transfers besides the above mentioned and will have a closer look at technologies such as depyrogenation tunnel, rapid transfer ports and general liquid transfer possibilities.
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  • De-risking your Drug-Device Combination Product Abbreviated New Drug Application submission: A Case Study on Leveraging Formative Human Factors Data Generated by a Device Constituent Developer

    Chloé Stoll
    Chloé Stoll
    Clinical and Human Factors Senior Specialist
    BD
    Abstract

    When submitting a generic drug-device combination product in the US, pharmaceutical companies must follow the FDA guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry”. As part of this guidance, a threshold analysis is performed to assess the differences between the Reference Listed Drug (RLD) and the generic drug-device combination product. If “other” differences are identified, a comparative use human factors (CUHF) study may be needed to prove the non-inferiority between the two products. 

    During this presentation, a case study will show how a device constituent developer performed a comparative analysis and formative CUHF study to help inform pharmaceutical companies’ final CUHF parameters and de-risk their combination product ANDA submission.

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  • Driving Towards Net Zero; A Sustainable and Circular Design Approach with Delrin® Polyoxymethylene (POM) for High-Performance Plastic Components in Injection Devices

    Elizabeth Stubbs, PhD
    Elizabeth Stubbs, PhD
    Senior Scientist
    Delrin
    Abstract

    A pressing challenge facing designers of medical devices today is the goal to develop robust products while striving towards net-zero carbon emissions. Delrin® acetal can contribute to this journey.

    This presentation considers the whole life cycle of a device, considering material selection, component design, energy in manufacture and end of life considerations, including handling of returned post-consumer devices.

    Using the example of an autoinjector device, the discussion begins with material selection, comparing global warming potential (GWP) of the various plastics in use today. Here we describe how Delrin Renewable Attributed, produced from renewable feedstock, shows potential to reduce GWP significantly while maintaining the properties and regulatory compliance.

    Next the focus is design, considering how harnessing a material’s superior mechanical properties and long-term performance, enables the design of products with less material and greater longevity.

    With low GWP materials the need to accurately model the energy of injection molding becomes increasingly important.  This section provides insight into how alternative models can better match the reality.

    Finally, we will consider practical end-of-life considerations of devices including opportunities for mechanical recycling by exploring mixed plastic separation through processes such as density, electrostatic and NIR separation – assessing their yield and efficiency.

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  • Integrating the Voice of the Patient (VoP) in Drug Delivery Device Strategy and Development: A Path Toward Patient-Centric Innovation

    Mark Tunkel
    Mark Tunkel
    Global Category Director - Services
    Nemera
    Abstract
    This poster will showcase the role of the Voice of the Patient (VoP) in guiding the development of drug delivery devices. Highlighting the importance of patient-centric design, as emphasized by the FDA's "Patient-Focused Drug Development" guidance, the presentation will outline how integrating VoP from the initial stages of development can drive personalized healthcare solutions. It will further visualize the concept of VoP, differentiating it from human factors and usability, and underscore its significance as a foundational element for design and development in the pharmaceutical industry and the impact on devices, packaging, training, instructions for use, and digital health applications.
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  • Balancing Formulation and Device Integration: Insights into Challenges and Alternatives in High Concentration Subcutaneous Drug Development

    Daniel Waites
    Daniel Waites
    Director, Research & Development
    Enable Injections
    Abstract

    The growing demand for subcutaneous (SC) drug administration, especially for high-dose indications, has driven the development of high concentration formulations. While chemical issues like deamidation and isomerization are typically independent of drug delivery, physical challenges such as aggregation, viscosity, and volume are closely tied to device selection. High concentration formulations also face reduced yields due to potential equipment adsorption and blockages, further linking formulation and device teams in SC combination product development. Despite this interconnectedness, cross-functional team members without a background in formulation science often fail to appreciate the time, costs, and risks involved in creating high concentration SC formulations. This misunderstanding can lead to project timeline delays, ultimately affecting clinical trial entry and product launch.

    This survey study delves into expert opinions and insights from formulation science experts regarding challenges with high-concentration formulations, their preferred ways of working with device teams, and their preferences in SC combination product development. The goal is to understand the trade-offs between high and low concentration formulations in SC combination product development. Additionally, it examines the utility of on-body delivery systems with large volume capacities (5-25 mL) as an alternative to developing high-concentration formulations, which may reduce formulation complexity and associated risks.

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  • Life Cycle Assessment (LCA) and Comparison of Five Sterile Injectable Platforms

    Laura P. Weidner
    Laura P. Weidner
    Head of Corporate Development & Quality
    ApiJect
    Abstract

    There is an increasing recognition that health care and its supply chains are important contributors to greenhouse gas emissions (GHG). Today they collectively represent 8.5% of US GHG emissions, and approximately 5% of global emissions. This presentation will review a Life Cycle Assessment (LCA) performed per ISO 14040 and 14044 that quantifies the environmental impact of five different sterile drug injection solutions:

    1. Single-Dose Glass Vials and Syringes
    2. Multi-Dose Glass Vials with Syringes
    3. Luer Prefilled Syringes
    4. Staked-type Prefilled Syringes
    5. ApiJect Platform (blow-fill-seal container and needle assembly)

    The LCA includes comprehensive life cycle stages from cradle-to-grave, encompassing all upstream materials production, manufacturing, inspection, packaging, transportation, use, and waste management. The study finds a substantial difference in the environmental impact comparing the injection platforms, favoring the ApiJect Platform across all categories of resource use and environmental impact. The carbon footprint impact is especially noteworthy.

    Disclaimer: the ISO 14040 and ISO 14044 critical review is in process and will be completed prior to the conference in October.

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  • Using Behavior Design to Optimize the Patient Experience in Smart Devices and Digital Health Applications

    Lara Zaki, MSc
    Lara Zaki, MSc
    FEI Strategy and Innovation Consultant
    Team Consulting
    Abstract

    Smart devices and the digital health applications that support the training and use of injection devices can be powerful tools to enhance patient engagement and promote better health outcomes. Effectively leveraging these digital technologies relies on a robust understanding of the patient, their care journey, and the behaviors and mentalities that have the greatest impact on device use.

    In this talk, the presenter will highlight a behavior design framework that demonstrates how device manufacturers can embed an understanding of the patient in the design of digital health applications, to effectively target engagement and adherence. The framework will illustrate how to:

    1. Conduct exploratory research and experience mapping activities to contextualize injection device use, errors, and anxieties within broader care journeys.
    2. Translate this research to prioritize pain-points and behaviors that have the greatest impact on clinical outcomes, and thus are the most relevant to specifically target in the product design.
    3. Apply behavior science methods to identify techniques from the literature that have shown success in analogous use cases, ensuring concept designs (e.g. educational tools, adherence tracking) are rooted in evidence.
    4. Iteratively conduct UX design activities informed by risk-benefit analysis, behavior science, and user insights.
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  • Bernd Zeiss, Dipl.-Biol.
    Bernd Zeiss, Dipl.-Biol.
    Head of Scientific Affairs and Application Technologies
    Gerresheimer
    Abstract
    Prefilled syringes are complex medical devices. Smooth and flawless syringe system functionality is key for Pharma with regard to patient safety. Suppliers of prefilled syringe components such as barrel and elastomer manufacturers, but also autoinjector makers proactively test and qualify their components. The task of integrating all these components with the final drug candidate and test the final combination product before market release lies on the Pharma drug manufacturer . One major guidance for testing these requirements and test methods for finished prefilled syringes is ISO 11040-8. Although component suppliers can only carry out drug-agnostic testing, a wide range of syringe performance indicators can be scrutinized in joint projects to collect relevant data. Pharma customers strongly benefit from supplier cooperation, as deeper system knowledge prevents many pitfalls at Pharma by minimizing risk of syringe system failure, reducing R&D efforts and accelerating time to market. Gerresheimer, Aptar Pharma and autoinjector manufactureres work together to fill data gaps and tackle unmet needs of Pharma companies regarding syringe system performance. This study specifically addresses break-loose & gliding forces carried out with model solutions, needle shield pull-off force of different RNS, and shows data  for integration of syringes into auto-injectors.
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