Breathable, Film, or High Barrier: How to Select the Right Medical Pouch Packaging

Medical pouch packaging is a proven solution for medical devices. In addition to being lightweight, portable, and easy to store, medical device pouches aid in maintaining product sterilization, protection, and safety.

To maximize the benefits, the pouch design, materials, and barrier protections must align with the particular application.

4 Things About Medical Devices That Could Impact Packaging

Medical pouches are versatile, and it’s tempting to think of them as one-size-fits-all. The reality is that medical pouch packaging is crafted to accommodate the specific features of medical devices.

Before pursuing a pouch solution, it’s essential to gain clarity about key factors of a medical device that could impact packaging decisions, including:

• Device criticality and sterilization needs: The U.S. Centers for Disease Control and Prevention (CDC) have established three tiers of medical devices:

  • Critical devices: Require sterilization (e.g., surgical instruments, implants, ultrasound probes, catheters, etc.)
  • Semi-critical devices: Require high-level disinfection because of device contact with mucous membranes, cuts, or abrasions (e.g., anesthesia equipment, laryngoscope blades, esophageal probes, etc.)
  • Noncritical devices: No CDC sterilization or high-level disinfection requirements because of the low risk of infection (e.g., blood pressure cuffs, stethoscopes, oxygen saturation monitors, etc.)

• Device protection: Medical devices may be delicate, sizable, heavy, or otherwise challenge packaging integrity. How durable must the pouch be to adequately protect the medical device?

• Device visibility: The ability to visually inspect a medical device in packaging at point of use may be required, or visibility may be a priority for accurate storage and retrieval of devices

• Device environment: Device sensitivity to particular environmental conditions — principally moisture, oxygen, or light ingress — drives certain aspects of materials selection

How Materials Selection Determines Pouch Characteristics

Medical pouches are constructed by pairing two webs of materials and heat sealing them on three sides. The remaining opening is heat-sealed after device insertion.

The materials used put pouches in one of three medical packaging categories:

• Breathable: Porosity is the key to breathable pouches. Therefore, at least one web is made using coated paper or DuPont™ Tyvek®, such as Amcor Grid Coated Paper, Direct Seal Paper, and Uncoated DuPont™ Tyvek®.

  Breathable pouches withstand EO sterilization and are generally used for applications requiring a high level of disinfection. The porous web maintains product sterility while still offering the breathability needed, and can also be helpful in instances where pressure or altitude changes are a concern.

  Breathable pouches are versatile and typically have a chevron or corner peel opening feature. They are used for a range of devices such as catheters, gowns, wound-care products, orthopedics, syringes, diagnostic devices, and cardiovascular applications.

• Film-to-film: Extrusion films address a wide range of package integrity needs, from EO and E-Beam microbial barriers to safe, simple aseptic access. Amcor SureForm Forming Films provide polyolefin and nylon thermoforming solutions, while Amcor Standard Medical Laminates are strong, multi-layered proprietary sealant films. Both are ideal for pairing with Amcor EasyPeel technology for safe, reliable peel-open packaging systems.

  Film-to-film pouches are commonly used for situations where enhanced product protection and visibility is required. Material combinations range from basic options for lightweight devices to more premium constructions for heavier products that need puncture resistance. Combinations can be offered as peelable or non-peelable depending on end user needs, and most combinations are compatible E-beam and gamma radiation sterilization methods. Syringes, orthopedics, endoscopic devices, tubing sets, and procedure kits are several examples of the applications appropriate for film-to-film pouches.

• High Barrier: To maximize shelf life, sensitive medical devices must be shielded from light, oxygen, and moisture. To accomplish this, high barrier pouches combine films, foils, and barrier coatings. Amcor Crystal Shield Medical Laminates and High Shield Medical Laminates are comprehensive solutions that exceed performance expectations.

  Barrier pouches are typically used for applications such as cardiac catheters, guidewires, implants, diagnostics, and drug-coated products, but are not limited to these market end-uses. Similar to film-to-film pouches, these pouch combinations can be offered in peelable or non-peelable formats and various degrees of performance options.

Sterilization for Medical Device Pouches

In addition to categorization, pouch materials dictate medical device sterilization capabilities. Likewise, the materials chosen play a role in compliance. Pouches must comply with ISO 11607 requirements for sterilization, microorganism contamination prevention, and aseptic presentation.

Therefore, it’s imperative that strict attention be given to how pouch materials respond to:

• Ethylene Oxide Gas (EO) is a chemical agent that interferes with protein metabolism and cell reproduction to kill microorganisms on medical device materials sensitive to radiation
• Gamma Radiation, a byproduct of the disintegration of the radioactive isotope Cobalt 60, is used in safety-shielded environments to sterilize disposable medical devices over a period of time
• Electron Beam (E-Beam) transmits a high-voltage beam of free electrons from a linear accelerator to penetrate and sterilize low-density or thin devices

Medical Device Packaging Partners: Insights and Innovations

Pouches are a sought-after packaging solution within the medical industry. Working with an experienced packaging partner gives manufacturers a decided advantage in making informed decisions about medical packaging products.

But packaging partners give manufacturers more than peace of mind. Collaborating with Amcor means access to a broad portfolio of healthcare packaging solutions, innovations like the Dual Chamber Pouch, and insights like those you’ll find in The Insider’s Guide to Sterile Barrier Packaging.

_{DuPont™ and Tyvek® are trademarks or registered trademarks of E. I. du Pont de Nemours and Company or its affiliates.}