Our 18th Year of Publication
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Cover Story

Medical Device Packaging

  • The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. The device components and the packaging system should be combined to create a product that performs efficiently, safely, and effectively in the hands of the user.

  • The packaging system shall be designed to minimize the safety hazard to the user and patient under the intended specified conditions of use.

  • The packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall allow for sterilization and be compatible with the chosen processes. The sterile barrier system shall maintain sterility until the point of use or until the expiry date.

  • Maintenance of sterile barrier integrity may be used to demonstrate maintenance of sterility. The loss of sterility is regarded as event-related rather than time-related. When similar medical devices use the same packaging system, a rationale for establishing similarities and identifying the worst-case configuration shall be documented.

  • The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare facilities for use in internal sterilization are considered as medical devices in many parts of the world.

  • One significant barrier to harmonization was terminology. The terms “package,” “final package,” “final pack,” “primary pack,” and “primary package” all have different connotations around the globe, and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document.

  • As a result, the term “sterile barrier system” was introduced to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags or hospital packaging reels.

Key Drivers In Medical-Device Packaging

  • One is to help reduce hospital-acquired infections, which requires packaging that maintains its integrity, withstands sterilization, and protects against damage to expensive devices.

  • A second trend is easy identification and handling of medical devices that require transparent packaging materials before and after sterilization.

  • Third driver is cost containment. Eastman is collaborating with packaging engineers early on to understand their needs to work through the packaging design process and material selection, which helps them execute that design without compromising performance.

Sustainability Issues With Regard To Medical Device Packaging

The safety of patients and the healthcare professionals who interact with the packaging are the top two priorities. Then the third part is sustainability. There are emerging purchasing programs, such as environmentally preferred purchasing, that examine what happens to the packaging materials from an end-of-life standpoint.

Put quality systems in place to define processes to eliminate hazards in packaging

  • The goal of a thorough packaging system hazard analysis is to eliminate all high-severity hazards and reduce as many medium- and low-severity hazards as possible. Two prime high-severity hazards are breach of the sterile barrier (for a sterile barrier package) and damage to the medical device, which is not easily detectable and may impact the safe and effective use of the device.

  • The number-one failure mode for a sterile medical-device package is the loss of physical package integrity, such as holes, tears, punctures, and open seals. Hazard analyses will assist in determining how the loss of physical integrity occurs in your package design.

Develop design inputs

  • customer requirements;

  • the mass and configuration of the product;

  • the presence of sharp edges or protrusions;

  • the need for physical and other protection;

  • the sensitivity of the product to particular risks, e.g. radiation, moisture, mechanical shock, static


  • the number of products per package system;

  • package labeling requirements;

  • environmental limitations;

  • expiry date limitations of the product;

  • distribution, handling, storage environment;

  • Sterilization compatibility and residuals.

  • Also Create a document that defines product protection requirements, including fragility, light, temperature, oxygen, and moisture, before picking out packaging materials. Evaluate competitive devices to understand how they package their products—learn from the good and the bad examples.



Consider distribution, storage, and handling

  • Perform a thorough analysis of distribution conditions for your medical device. With clinical trial packaging, you have low volumes of packages being sent to many distant sites. Conduct an environmental monitoring study of cold-chain packaging, understanding how a package may be exposed to extreme conditions.

Understand that the selection and evaluation of materials and sterilization compatibility is critical.


Use real-time aging to test package shelf life and stability

  • Companies conduct accelerated aging because they don’t want to wait for data. Consult with the effect of time on seal integrity as discussed in Q10-2 in ASTM F1980-07 guidance document, “Accelerated aging for sterile barrier systems.”

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