Auto Epinephrine Injector-GettyImages-1301956816 Human Factors Considerations For Your Emergency Use Drug Delivery Device

Emergency use medical devices have seen the autoinjector EpiPen leading the way, followed by the emergence of naloxone nasal sprays and autoinjectors for the treatment of opioid overdose, and others. There are use-related challenges in emergency situations, so you will need to give careful consideration to the human factors involved with who is using the device and how it is accessed.


Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.



  • ASEP-TECH® Blow/Fill/Seal systems are ideally suited for packaging injectable products, including small-volume and large-volume parenterals. Containers are formed, filled, and sealed in one compact machine frame, eliminating many of the steps and additional expenses of conventional processing. Blow/Fill/Seal containers offer tremendous advantages over glass, including weight savings, particle-free processing, resistance to breakage, ease of opening, and recycling capability.

  • As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.

  • Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.

  • Ajinomoto Bio-Pharma Services offers the capacity and quality to scale your process through clinical development and commercialization.

  • We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.

  • Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.

  • Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.

  • Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

  • The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.

  • Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.