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Medical Device Packaging – An Overview

calendar16 Mar, 2023
timeReading Time: 6 Minutes
Medical Device Packaging - An Overview

One component, the medical device packaging, frequently gets overlooked while developing or thinking through the production process for a medical device. The packing may be lost in the sea of other concerns that must be attended to. Yet, using the appropriate packaging can cut costs, possibly improve sterilizing procedures, and facilitate manufacturing. Early packaging consideration is important since it can prevent production delays, increase prices for both manufacturers and patients, and cause other problems.

The significance of medical device packaging is unmatched because of the vital equipment it transports. For this kind of packaging, safety, and security precautions are of the utmost importance. 31% of medical device recalls are linked to packaging issues, which account for 10% of recalls overall.

To retain the sterility of its contents until the time of use, medical device packaging is crucial. This must be done while carefully balancing the many factors that must be taken into account during the package construction process. Bags, overwraps, pouches, trays, and clamshells are examples of types. They are made of a range of materials, some flexible and others stiff.

Packaging for medical devices is governed globally. If the packing is sterile or other for a manual non-active device or an active device will determine the type of requirements that will apply to it. Even if he can use contract testing labs or packaging facilities for this, the legal manufacturer’s responsibility is primarily to ensure that the packaging can carry out the intended functions. The usage of a lot of specialized equipment is required in the medical profession, and in some circumstances, if the equipment is not quickly discarded after use, it is frequently breakable.

What is a Medical Device?

A medical device may be defined as any appliance, instrument, material, apparatus, or another article, either used in a singular form in combination with other equipment/devices, including the software essential for its intended purpose by the manufacturer to be used for human beings.

People are increasingly concerned about their health as a result of emerging economies and rising awareness. People are willing to choose cutting-edge technologies and solutions to enhance their health, regardless of the cost. As a result, the industry for medical devices in the healthcare sector has seen tremendous expansion. The medical device sector also includes subsectors such as diagnostics, imaging, cardiology, surgical, and orthopedic equipment.

Importance of Medical Device Packaging

To get the medical device to market safely, securely, and with the sterile barrier maintained, the packaging is a crucial component. Improper packaging can compromise medical devices and their users’ safety. A sterile medical equipment packaging must not only survive or remain on a shelf for years without breaking but must also arrive at hospitals and clinics without any holes or broken seals.

According to the importance of medical device packaging, the packing of medical devices is generally done in a clean environment, and the packed devices typically go through some sort of sterilization. Yet, the packaging’s job is to maintain the tool sterile up until use. Hence, choosing the right packaging is an important but difficult choice, and statistics show that it is frequently made incorrectly.

With its own unique set of safety and security considerations, the packaging of medical devices is an essential component of the industry for a good reason. There are several uses for packaging. It can show vital product information and brand marketing in addition to safeguarding a product from damage or tampering during transit.

FDA-Recognized Standard ISO 11607

The standard has three main pillars:

  • A manufacturer must be able to form and seal a package consistently, adhering to specifications for the bond’s strength and seal after heat-sealing, the seal’s aesthetic appeal, and the package’s opening ability.
  • The package design must be sufficiently robust to withstand shipping through all types of climates and a variety of physical hazards, as if the end-user in an ambulance, hospital, or clinic has difficulty opening a package, it may rip or tear, exposing the device inside to contamination and rendering it unusable. To mimic the various dangers that packages might face, PCL subjects them to simulations of dropping, compression, vibration, collisions, sub-zero temperatures, desert environments, and tropical climates.
  • The integrity of a package must endure throughout time. It typically lasts for two years in packaging for a sterile, disposable gadget. PCL uses both accelerated aging, which involves baking the package, and real-time aging in a controlled atmosphere.

Standards for Medical Device Packaging

The most crucial information is a summary of where the necessary medical packaging ISO 11607-1 standards stand right now. Medical device packaging is required to meet the following criteria:

  • Manufactured of well-known and traceable materials
  • Non-toxic, non-leaching, and odorless
  • Free from holes, cracks, tears, wrinkles, and localized thinning
  • Designed for use in medical applications.

Moreover, it must:

  • Permit sterilization;
  • Offer physical protection;
  • Maintain sterility until the point of use; and
  • Permit aseptic presentation.

Packaging is a crucial component of the medical device market, and it comes with its own unique set of security and consumer safety considerations. The packaging serves a variety of functions, including brand promotion and informational display in addition to safeguarding the product from harm or contamination.

ISO 11607-2-2019[1]: Validation requirement for forming, sealing, and assembly process.  

This document outlines the specifications for packaging medical equipment that has undergone terminal sterilization. This technique also includes packaging systems as well as partially sterile barrier systems that are formed, sealed, and gathered.

It has to do with the businesses, hospitals, and locations where medical equipment is packaged and sterilized. The specifications for the packing of cleanly made medical devices are not covered. Drug/device combinations would need additional specifications.

Some Other Considerations for Medical Device Packaging

If you thought that was all there was to consider regarding the packaging aspect, you haven’t even reached the halfway point. None of these decisions are too minor, and they should all be made early on to allow for flexibility in case issues occur. To ensure good packaging and sell a product, consider the following extra factors:

  • Labeling on the packing must be legible and strategically positioned;
  • A package shouldn’t be either too small or too huge.
  • The raw materials used in the packaging of sterile medical devices must be traceable, secure, and capable of effectively forming a microbiological barrier. 
  • To ensure that the machinery used to manufacture packages performs according to specification, it must be installed, maintained, and operated in a validated state.
  • The finished packages need to pass numerous quality assurance tests.
  • How will the package incorporate the device’s operating instructions?

Packaging Testing and Process Validation

The last steps required to introduce your device to the rest of the world can be carried out once you’ve finally decided on the kind of packaging you desire. The procedure of testing and validation will now be used to determine how reliable the packaging manufacturer is. In addition to ensuring that the pouch seals fulfill a minimum peel strength standard, medical device packaging must also be tested to ensure that neither the device nor the pouch will be harmed during transportation. Even if you are using previously used packaging, these two tests must be performed.

  • Testing for package integrity. A medical gadget or product’s sterility and shelf life are determined by this.
  • Testing for package strength. This experiment demonstrates the amount of force needed to separate the two parts of the sterile barrier system.

Once these requirements have been met and the testing has been completed and approved, you will have medical device packaging that is prepared to ship your item to market.

How to Improve Medical Device Packaging?

  • Safety: When it comes to successful medical packaging, safety may be the most important factor. In general, several factors must be taken into account while creating the optimum packaging solution for medical equipment. First, the proper material needs to be chosen. It must be determined whether the material used to package sterile medical devices is effective and safe for forming a microbial barrier. The design of the box must be strong enough to endure all climatic conditions and physical dangers.
  • Detectable:  The term “detectable” refers to a product’s marketing visibility or its actual visibility due to packaging. Because the hospital or medical office has already purchased the product, marketing has less of an impact on the packaging of medical products. When it comes to healthcare professionals readily identifying the equipment they require, a product’s actual visibility can make a significant impact.
  • Simple Use and Applicability:  The basic goal of a medical gadget is to effectively deliver, not merely to protect. The most underappreciated aspect of efficient medical device packaging is typically its ease of use. The mission is only halfway completed if it is trustworthy, safe, and identified. Next, is it integrated? This point might not be crucial while opening things in our daily life. It’s crucial that medical equipment packaging is clear and easy to understand.


In the highly competitive medical device market of today, the packaging is just as crucial as the actual medical item. Packaging is a crucial component of the medical device market, and it comes with its own unique set of security and consumer safety considerations. The packaging serves a variety of functions, including brand promotion and informational display in addition to safeguarding the product from harm or contamination. Sometimes a medical device’s packaging is made to be just as exclusive. The packing must preserve sterile packaging to safeguard the device throughout usage or transportation.

Also Read:
A Step By Step Guide For Registration Process For Medical Devices In India

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