EO Sterilisation & Packaging
#MEDISTRI
#MEDISTRI
Medistri continues to be at the forefront of regulatory requirements and quality proficiency.The design of a medical device’s packaging plays a critical role in ensuring the product’s success and safety. It should be developed during the early stages of the device’s creation to avoid costly challenges later. Packaging is not just a protective layer; it serves as a sterile barrier that safeguards the medical device from manufacturing to final use.
Medical device packaging is the system used to contain, protect, and deliver medical devices in a sterile condition until their use. Beyond meeting validation and regulatory criteria, the packaging must ensure the device remains sterile and undamaged during transportation, storage, and handling.
Medical device packaging is crucial for several reasons:
Maintaining Sterility: The primary goal is to ensure the device remains sterile until it is used by the patient.
Preventing Delays: Proper packaging design prevents costly delays during the sterilisation validation stage.
Ensuring Safety: It protects the product from environmental and physical damage during transit and storage.
Effective medical device packaging involves choosing materials that can withstand sterilisation parameters, allow sterilant penetration, and maintain sterility post-processing. Packaging engineers must have a thorough understanding of cycle parameters such as temperatures, dwell times, and pressure to design effective solutions. Additionally, packaging systems undergo rigorous testing to demonstrate their strength, reliability, and ability to maintain sterility
Medical device packaging must be durable enough to withstand sterilisation and handling. It should also incorporate breathable, porous materials suitable for EO processing, ensuring ease of sterilisation and compliance with industry standards.
Collaborating with experienced professionals early in the product development process is essential for successful medical device packaging. Medistri’s team, with over a decade of experience, works closely with healthcare innovators to create packaging solutions that meet the highest standards, ensuring safety, efficiency, and regulatory compliance.
🎯 To learn more about EO Sterilisation & Packaging, visit our website here or directly contact our team at contact@medistri.com.
— The Medistri Team
#Medistri
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