Sterilized medical device packaging must guarantee that the contents within will remain sterile throughout the entire lifecycle of the product – from the moment it leaves the factory until the final consumer opens it to use it. The ISO 11607 standard addresses this industry need, providing a full guide on the way to guarantee that the package will meet this requirement and how to document it.
This packaging validation standard guarantees that the packaging has been manufactured in a way that is adequate for the product that it contains and that the products have been packaged in compliance with strict medical device packaging requirements. The ISO 11607 standard, therefore, offers an operational and essential requirement framework for medical packaging, focusing on key processes (such as sealing and other closure systems, in addition to its stacking and manipulation) so that the package remains sterile throughout its distribution cycle.
What is the ISO 11607 standard?The ISO 11607 standard is a document that outlines internationally recognized guidelines for the validation of terminally sterilized medical device packaging.
This standard is recognized by the FDA in the United States and the CE marking in the European Union. It is also applied globally and widely accepted in other countries such as Japan.
Companies related to any terminally sterilized medical device must meet this standard. This includes many levels – from the medical and pharmaceutical industry to healthcare centers or places where these products are applied or where a medical device is sterilized.
The main purpose of this standard is to ensure that a package is capable of withstanding the sterilization process and that, in addition, it can protect the products within until the moment that the user uses it.
The standard, which was updated in 2019 as part of 5-year revision cycles, consists of two parts:
- ISO 11607-1: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems. This part focuses on validating the packaging materials and package design through the fulfillment of a series of packaging validation requirements and a set of proposed packaging testing methods.
- ISO 11607-2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes addressing packaging process validations. This specifies the requirements for validating packaging for medical devices, including its forming, sealing and assembly for sterile barrier systems (SBS) and packaging systems.
Medical device packaging requirements according to ISO 11607The ISO 11607 standard outlines a packaging validation based on the characteristics of the medical packaging itself, such as them being able to undergo sterilization, to act as a barrier for microbes and to allow for an aseptic presentation.
To this end, it outlines over 100 conditions. Some of the most important medical device packaging requirements of ISO 11607 include:
- The packaging must offer protection and remain sterile until the moment of use. Moreover, the package must be resistant to sterilization. The latter implies certain processes (such as the use of ethylene oxide or radiation, among others) that might deform the packaging materials, discolor them or melt them, which means that they would be incompatible. The same applies to packaging labels, which might get erased, detached or fade if not taken into account. The fact is that not all packaging materials are suitable for all methods of sterilization. When performing this process, one must take into account both the Sterile Barrier System (the first barrier of the package that keeps the product sterile) and the protective packaging (that in other contexts is called secondary or tertiary packaging; in other words, the protective layers that follow the Sterile Barrier System).
- The standard also establishes requirements that refer to the moment when the user uses it. It recognizes this moment as essential in preventing infections or product contamination, by establishing that the protective packaging must allow for the aseptic presentation of the product through the Sterile Barrier System. This being the case, the new adjustments made in 2019 to the ISO 11607 standard establish that it is necessary to provide instructions for use that guarantee that the users will know how to safely use the product (e.g., include information on how to open the package or the safest place to do so). In addition, the standard specifies that the packaging must also include a guide on how to present the contents on a sterile field in an aseptic manner that is safe for use.
- Regarding packaging validation testing, the standard requires the company to have procedures in place for the design of an adequate packaging system, in addition to having to develop valid packaging testing methods that are documented by the laboratory in charge. This way, the ISO 11607 standard requires companies to take into account the conditions and circumstances that a medical package might encounter throughout its entire life, and to perform simulations to test how it will react to them. This includes the distribution cycle and the storage conditions of packaged medical products.
- Regarding testing, the standard also establishes that the company must perform sampling based on valid statistical foundations.
- This standard also describes the importance of stability testing, which must be performed not only for the product but also for the packaging materials.
In summary, the goal is to ensure that the service life of the package will match that of the product. This does not only apply to the Sterile Barrier System, but also to the packaging system as a whole.
Other requirements of the ISO 11607 standard include some requirements regarding the compatibility of labels, the effects of distribution on the product contained in the package, and the traceability of the packaging materials.
Fulfilling the standard’s medical device packaging requirements calls for a joint effort by several departments. This goes from those in charge of designing the package to quality, logistics or manufacturing. It is likewise important to take the end user into account, as well as the marketing and sales teams.
This entire process must be documented in writing, in order to perform a packaging validation process before the products are launched on the market.
Sterile barrier systems and packaging systemsThe 2019 update of the ISO 11607 standard has brought some changes for companies, which must guarantee compliance with the medical device packaging requirements.
In the case of sterile barrier systems and packaging systems, new terminology has been included that must be used by companies in the fulfillment of the standard and its associated documentation:
- The terminology that refers to “medical device primary packaging” has been eliminated, being replaced by “Sterile Barrier System” (SBS). This term is used to refer to the packaging that minimizes the risk of microorganism entry and allows for an aseptic presentation of the sterile contents until the moment of use by the end user. Sterilization implies, on one hand, preventing the entrance of microbes into the packaging and, on the other, that the packaging must remain intact (without openings or holes) until it is opened for use.
- The term “protective packaging” was also included, and is defined as the configuration of materials designed to prevent damage to the Sterile Barrier System (SBS) and its contents until the moment of use.
- Lastly, the packaging system is defined as the combination of the Sterile Barrier System (SBS) and protective packaging.
How to determine your testing and packaging validation needsIn order to determine the right packaging testing methods, it is necessary to take into account the many possible scenarios to which the medical device and its packaging system might be subjected:
- Environmental factors such as temperature or moisture, which might compromise the integrity of the packaging system.
- The passage of time and its effect on the packaging materials.
- Unforeseen circumstances during transportation or automated storage of the medical device which might compromise the SBS.
Some examples include vibrations caused by the type of transportation and route, crushing due to the compression forces resulting from stacking one product over another, or impacts received during handling of the product, among others.
By performing these simulations, the company will be able to design an optimized packaging system that is able to handle the hazards that it might encounter in its path from the factory to the end consumer.
Ultimately, the goal is to anticipate a “worst-case scenario” in a way that the safety of the medical device inside the package can be guaranteed.
To accomplish this, it is essential to determine the specific testing needs for each product and perform the packaging validation process. This process can be performed in one of two ways: having a partner (such as testing labs or institutes) that takes care of testing, or performing the tests in-house using simulation equipment, thereby avoiding the long processes outside the company’s control that outsourcing these services implies.
发表于 2021-10-25 17:00:28