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MEDICAL DEVICE STERILE BARRIER PACKAGING

 

  • Clean Rooms

  • Sterile Package Design

  • Sterile Barrier Systems

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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.

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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.

  • What classifications of clean rooms does Vitatek offer for medical device assembly?
    VitaTek offers ISO Class 5 and Class 7 clean rooms for medical device assembly, compliant with ISO 13485, FDA CFR 21 Part 820, ISO 14971, and ISO 14698 standards. These clean rooms meet rigorous biocontamination control and risk management requirements, ensuring top-quality medical device manufacturing.
  • How does a clean room environment help maintain product quality and compliance?
    A clean room maintains product quality and compliance by strictly controlling particulates, temperature, and humidity, which minimizes contamination risks. This controlled environment is essential for meeting regulatory standards, ensuring medical devices are safe, sterile, and reliable for patient use.
  • What processes are completed in a medical clean room versus a standard assembly area?
    A medical clean room handles processes like sterilization, final assembly, packaging, and inspection under strict contamination controls, ensuring device safety and regulatory compliance. Standard assembly areas, with less stringent controls, are used for non-sterile tasks like general assembly or initial testing that don't require low-particulate environments.
  • What are the typical quality control measures taken in clean room assembly?
    Typical quality control measures in clean room assembly include monitoring air quality, regular equipment sterilization, precise environmental controls (temperature, humidity), and frequent particulate testing. Devices undergo inspections at each stage to ensure cleanliness, functionality, and adherence to regulatory standards, safeguarding device safety and reliability.
  • How does Vitatek ensure that clean room and assembly standards meet regulatory requirements?
    VitaTek ensures that clean room and assembly standards meet regulatory requirements by following strict ISO 13485 and FDA GMP guidelines. We perform routine audits, monitor environmental conditions, and validate equipment regularly. Additionally, our team is thoroughly trained, and we maintain comprehensive documentation to ensure ongoing compliance and device safety.
  • Can Vitatek handle sterilization and final assembly in-house, and what advantages does this provide?
    Yes, VitaTek handles both sterilization (ETO) and final assembly in-house. Our vertically integrated services streamline communication and timelines, ensuring faster development and quicker time to market. This approach simplifies the process for customers, reduces lead times, and accelerates medical device commercialization.
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