MEDICAL DEVICE DEVELOPMENT MANUFACTURING. EVERYTHING IN-HOUSE.
STERILE BARRIER PACKAGING
Sterile Barrier Overview
Sterile barrier packaging is essential for ensuring that medical devices remain uncontaminated until their use. Also known as sterile barrier systems (SBS), these packaging solutions are designed to prevent microbial entry and protect devices through sterilization, transport, and storage. SBS materials typically include robust, sterilization-compatible options like medical-grade paper, plastic films, and laminates, each chosen based on durability and compatibility with sterilization methods such as ethylene oxide or gamma radiation.
Importance and Design of SBS
Sterile barrier packaging systems not only safeguard sterility but are also engineered for ease of use by healthcare providers, facilitating aseptic presentation during procedures. To achieve this, the packaging must withstand the rigors of sterilization processes without compromising its integrity or protective features.
Key Components and Manufacturing Processes
Common materials for SBS include flexible films, paper, and foils that offer varied barrier properties, supporting customized protection based on device needs. Methods such as heat sealing or ultrasonic welding create secure seals essential to prevent microbial ingress.
Regulatory Compliance and Standards
Sterile barrier packaging must adhere to stringent regulatory standards like ISO 11607, which defines requirements for the design and validation of SBS in medical settings. Meeting these standards ensures reliable performance, safety, and sterility for patient care.