Capabilities
E3D focuses on the design, development, engineering and commercial-scale manufacturing of drug delivery devices such as auto-injectors, pen devices and on-body injectors, primarily for home-based therapies.
Through close collaboration, E3D strives to understand the specific needs of partners and patient populations – in order to provide standardized device platforms or create innovative, customized products to meet those needs.
E3D has invested in the establishment of an international manufacturing infrastructure for its devices and has a record of development and commercial-scale supply of injectable delivery devices. This enables our partners to benefit through access to proven device technology platforms and reduced time-to-market.
Manufacturing Processes and Compliance
Our automated manufacturing processes combine sophisticated equipment within advanced facilities to ensure the production of consistently high-quality products.
Device components are produced using state-of-the-art tooling and multi-cavity (including two-component) molds in versatile injection molding machines. These components are then assembled on semi-automated and automated production lines, as appropriate to each device and its required manufacturing volumes.
The entire manufacturing process, from tooling to packing and shipping, is carried out under an ISO-certified quality management system. All barcoded lots are stored and dispatched using computerized logistics to provide full traceability for each product shipped to customers.
Our products are manufactured in our four Class 8 clean rooms:
- Israel (2 sites): 6,950m²
- Italy (2 sites): 4,000 m2
We also have device manufacturing facilities in the USA through an established partnership with a leading global contract device manufacturing group.
For additional information please contact: elcamqa@elcam.co.il
Quality & Regulatory
E3D’s policy is to provide each customer with the package of quality and regulatory measures which is most appropriate to their specific requirements.
Our quality dimensions are:
- High-performing, defect-free products
- Excellent customer service and support
- Design and engineering innovation
- On-time delivery
- Competitive prices
General information
Manufacturing is undertaken in a clean room environment (Class 100,000, according to Federal Standard 209E; ISO 14644 Class 8). Production, warehousing, components, documentation and traceability are performed in full accordance with the FDA Quality System Regulation: Title 21 CFR 820, effective from 1997.
Elcam Medical Quality Assurance and Regulatory system complies with and is certified for ISO 13485 standard.
Elcam Medical Health and Safety policy is in compliance with OHSAS18001:2007 – “Occupational health and safety management systems.”
All materials in use comply with biocompatibility requirements according to ISO 10993-1 and USP Class V test requirements.
Compliance with Quality System Regulations
Elcam Medical manufactures in a clean room environment (class 100,000, according to Federal Standard 209E. ISO 14644 class 8). Production, warehousing, components, documentation and traceability are performed in full accordance with the FDA Quality System Regulation: Title 21 CFR 820, effective from 1997.
Compliance with ISO 13485 standard
Elcam Medical Quality Assurance and Regulatory system complies with and is certified for ISO 13485 standard.
Compliance with OHSAS 18001:2007
Elcam Medical health and safety policy is in compliance with “OHSAS 18001:2007” – Occupational health and safety management systems.
Biocompatibility Testing
All materials in use comply with biocompatibility requirements according to ISO 10993-1 and USP Class V test requirements.
Development
Elcam and E3D have over 35 years of experience in medical device development, managing the process from understanding marketing requirements and engineering feasibility through the various elements of invention and patent registration. E3D employs an established methodology that incorporates stage gates of preliminary, detailed, and critical design reviews (both for the product and the manufacturing process), risk management through the development process, product verification involving both internal and external laboratories, biocompatibility, shipping tests, standards tests, formative and summative usability studies, process validation tests and design transfer to manufacturing according to well-established processes.
With a flexible and responsive approach, E3D can adjust project phases and timelines according to customers’ internal and external constraints and needs.
