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Frequently Asked Questions: Sterile Medical Packaging

Sterile packaging is an essential component of manufacturing for the medical industry.

A doctor’s duty, above all else, is to ensure the safety of their patient. Part of that means knowing that the instruments and tools they use throughout treatment are safe and sterile, which comes down to how those instruments are manufactured, packaged, and handled.

At Janco, our team has served the medical industry for six decades. Our quality assurance processes, understanding of unique industry standards, and cleanroom capabilities are second to none. Below, we answer the most common questions surrounding manufacturing for medical packaging in our own facility and beyond.

Is sterile packaging used for medical devices?

Yes, sterile packaging is used for several types of medical devices, including surgical instruments, catheters, single-use instrument trays, and more.

Why do we sterilize packaging materials?

Sterile packaging is an essential component of contract medical manufacturing. When surgeons and doctors utilize certain instruments on patients, it’s crucial that those instruments are kept free of particulates and other contaminants that may harm the patient. Surgical trays, for example, which can contain a wide range of instruments and tools, have to be kept sterile before entering the operating room, as any contamination can lead to infections and other complications with the patient.

Patient safety is the main priority of every doctor, so ensuring the sterility of medical instruments and devices used for treatment or surgery is key to the effectiveness of the duty. Sterile instruments prevent the spread of disease and bacterial infections.

How are packaging materials sterilized?

There are a number of potential methods to sterilize packaging materials. Our team manufactures packaging and products in sterile environments, our ISO-certified class 7 and 8 cleanrooms, and then sends them to an outside partner to be sterilized.

Cleanrooms ensure that products and packaging aren’t compromised by particulates and other contaminants that could compromise the devices or instruments.

What are the types of sterilization?

Methods of sterilization include ETO, gamma, e-beam, steam autoclave, and dry heat. The chosen method depends on the material used to package a product, ranging from plastic or paper to Polyfilm plastic tubing.

What is the shelf life of a sterile package?

According to the CDC, practices for sterilized instruments can be based on either date of sterilization or specific events, such as the packaging being opened. Some facilities put dates on every sterilized package based on shelf-life practices, but it’s more common that manufacturers utilize event-related shelf-life recommendations. This dictates that instruments or devices should remain sterile until a specific event causes contamination. That could include the pouch or seal being intentionally opened, accidentally torn or scratched, or wet.

Regardless of the date or event, all packages that require the internal instruments or devices to remain sterile should always be thoroughly inspected before use to verify that the package is not wet, torn, or damaged in any way. In some cases, the contents of the package may need to be resterilized before they can be used by doctors or surgeons.

Can you write on sterile packaging?

If writing is done on a sterilized package, it should be done on the plastic side, if there is one, and should be done using a non-toxic marker. This is because the plastic portion of the packaging is not permeable to the sterilant and will keep the content protected.

Labels for sterilized packages should typically include the date of sterilization, the expiration date (if there is one), and the type of sterilization used.

What is Tyvek® packaging?

Tyvek® is high-density polyethylene used to create pouches for sterile packaging needs. Its makeup, which consists of continuous filaments, creates a barrier that blocks particulates, microbes, and other contaminants from entering the pouch. Most commonly, Tyvek® pouches are often used for implants and other medical devices.

Our team purchases pouches from our circle of trusted vendors, performing the sealing in our facilities using a pouch sealer in our class 7 cleanroom.

Medical Manufacturing with Janco

Our team has experience working across several sectors of the medical industry on contract manufacturing projects, including:

  • Orthopedics
  • Vascular
  • Respiratory
  • Endoscopy
  • Laboratory
  • Cardiology
  • Ophthalmic
  • Spinal and Biologics
  • Dental
  • Pharmaceutical
  • Veterinary

Several of these fields require sterilized packaging to insure devices, instruments, and other tools are kept safe from contamination by particulates and other matter.

Ready to get started on your next project?

If you have questions about our process, want to know more about our team, or have a medical manufacturing project requiring sterile packaging that you think Janco can help add value to, reach out to us.

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