Sterile packaging is evolving rapidly, disrupted by technological advancements, regulatory changes, and demands for sustainability. As the global medical device packaging market grows, expected to reach a valuation of USD 136.3 billion in 2024 and expand at a 5.8% CAGR through 2034, these trends will shape how manufacturers deliver sterile implants to healthcare providers and patients alike. EU MDR is driving significant changes to how sterile packaging developers are addressing their products to ensure compliance.
Harmonization of ISO 11607 with EU MDR Sterile Packaging Requirements:
A key change of the EU MDR (Medical Device Regulation) versus the MDD (Medical Devices Directive) is the extended requirements for risk management, the following summary highlight the updates driven by the latest changes:
-
The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
-
Applying this to the SBS (Sterile Barrier System) which is a component or part of the sterile device necessary for the maintenance of sterility, is asking to ensure the SBS is designed to withstand the hazards which can occur during normal conditions of use. ISO 11607-1 outlines requirements to test for performance and stability to provide evidence of compliance.
-
Infection and microbial contamination – Devices and manufacturing processes shall be designed as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons. The package design shall:
-
Reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,
-
Allow easy and safe handling
-
Reduce as far as possible any microbial leakage from the device and/or microbial exposure during use
-
Prevent microbial contamination of the device or its content such as specimens or fluids.
In summary, a sterile barrier system is essential to a sterile medical device, playing a critical role to maintain sterility and allow for aseptic presentation. The Sterile Barrier Association has developed a guideline document for the useability of SBS which can be used as supporting documentation for such evaluation. Guardian Medical’s CapSure technology is the latest innovation in unparalleled ease and safe aseptic transfer, ensuring compliance and reducing risk of infection.
Guardian Medical’s CapSure Technology Supports Compliance:
Guardian Medical is at the forefront of sterile packaging innovation, offering solutions that address these emerging requirements with simple and robust pre-validated | 10-Year shelf life solutions. Our technology and services ensure we meet the demands of tomorrow’s sterile barrier packaging for the globe.
Regulatory Harmonization
In 2025, the focus on usability, unified safety symbols, tamper-evident features, and consistent labeling across regions will force device manufacturers to ensure their sterile packaging is compliant. Guardian’s packaging offers a turnkey solution to address the updated requirements for global compliance. Features such as tamper-evident seals and transparent materials enhance labeling and usability, aligning with ISO 11607 standards and EU MDR updates.
Sustainability and Usability
Our CapSure™ packaging system combines recycle ready materials with a minimal footprint design to reduce waste and shipping costs across the end-to-end value chain. CapSure enables a single sterile barrier and eliminates the need for secondary packaging, reducing the number of components needed for sterile packaged finished goods throughout distribution and storage.
Comprehensive Packaging Services
Beyond products, Guardian Medical provides end-to-end medical device packaging services, including:
-
Final cleaning using ultrasonic technology
-
Device assembly in Class 7 environments
-
Sterile barrier packaging in a Class 7 clean room
-
Label control, tamper-evident labeling, and shrink sleeving
-
Sterilization coordination to simplify supply chain for clients
These services ensure a seamless process from concept to market submission and on-going production packaging operations.
Speed-to-Market with Pre-Validation
Guardian Medical’s pre-validated sterile barrier designs eliminate the need for complex and costly validations, reducing lead times and resource demands. Getting devices to market has never been quicker or easier thanks to Guardian’s CapSure sterile barrier innovation.
The sterile packaging industry is moving toward a future shaped by sustainability, technology, and usability. Guardian Medical is positioned to help partners navigate these changes with innovative products and comprehensive services designed to enhance efficiency, compliance, and patient outcomes.
Discover how Guardian Medical’s solutions can prepare your business for the future. Visit guardianmedicalusa.com/contact to start a conversation.
References:
