Sterile Packaging for Medical Devices

Effective sterile packaging significantly lowers the risk of postoperative infection and complications.

As a manufacturer of medical products and packaging, one of our most essential functions is understanding and implementing the important standards that govern the industry. Ensuring that the products we manufacture follow strict medical industry guidelines is essential, including using the right tools and processes to prepare packaging and products for sterilization.

Why Sterilized Packaging is Important

Protecting patients is every doctor’s main priority, which is why it’s critical to make sure that medical instruments and devices used during surgery or treatment are sterile. Sterile medical devices and instruments help doctors prevent the spread of bacterial infections or diseases, effectively lowering the risk of avoidable complications.

The manufacturing and packaging of those instruments and devices are crucial to achieving and maintaining sterility. Thorough testing and various forms of validation are conducted on the packaging of most medical instruments to guarantee that they will remain sterile up until they are used in surgery or treatment.

Our Process

Janco purchases Tyvek® pouches (often used for implants and other medical devices) from a trusted circle of vendors, and we perform the sealing ourselves using a pouch sealer in our class 7 cleanroom.

For other projects, TPU sleeves are created in our ISO-certified class 8 cleanroom, sealing two sheets together before then placing them into a Tyvek® pouch and sealing the entire thing.

Within our state-of-the-art facilities, our team has the capacity to manufacture both small and large-scale production runs, depending on the needs of each client.

Sterile Product Packaging

Some of our most commonly-manufactured sterile products are medical trays made of thermoformed plastic. Thermoformed trays are both cost-effective and customizable, making them an ideal packaging option to keep medical devices and instruments secure.

We work with a wide range of medical sectors, including:

• Cardiology
• Orthopedics
• Vascular
• Respiratory
• Endoscopy
• Laboratory
• Ophthalmic
• Spinal and Biologics
• Dental
• And more

Each discipline has unique needs, so we work with you to customize the design of your trays, and other medical devices, to ensure that all of those needs are met in the most effective way possible.

Medical Manufacturing with Janco

For about six decades, Janco has been a trusted partner for medical manufacturing projects, because our team goes above and beyond to deliver innovation, quality, and customization.

Our thorough quality assurance processes, including frequent internal and external audits, keep our processes running smoothly and safely, so you have peace of mind knowing that your products are being manufactured and packaged with the highest level of quality and care.

Certifications

See all of our certifications here.

• High Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Low Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Packaging ISO 14644-1 Cleanroom Certification-Class 7
• Medical Device Assembly ISO 14644-1 Clean Room Certification- Class 8
• Foam Die Cut/Assembly ISO 14644-1 Clean Room Certification- Class 8
• Foam Molding ISO 14644-1, Cleanroom Certification- Class 8
• ISO 13485 Certification
• FDA Registered Facility

To learn more about our process or to get started on your next medical manufacturing project, reach out to our team today.