ISO 11167 plays a fundamental role in the requirements related to packaging for sterile medical device. The design of packaging which is able to maintain sterility of the device through its entire lifetime it is essential during the design and development phase of the device. In this post we present the main requirements associated to packaging for sterile medical devices.

In this article, we will go trough the most important requirements mentioned in the ISO 11167-1 and provide an overview of the main characteristics that need to be demonstrated for packaging of sterile medical device.

General Structure of the ISO 11167-1

The ISO 11167-1 is constituted by 11 sections. The first 3 sections are part of the introduction and include the scope and a glossary. The other sections of the standard can be summarised below:

  • General Requirements
  • Materials and preformed sterile barrier systems
  • Design for packaging systems
  • Usability studies of sterile packaging systems
  • Performance and stability of packaging systems
  • Validation approaches and Change Management for packaging systems
  • Inspection of medical device packages
  • Information to be provided in relation to sterile packaging systems

In the next section we will briefly performed an overview of these sections of the ISO 11167 standard.

General Requirements according to ISO 11167

Section 4 of ISO 11167 explains the general requirements associated to sterile packaging for medical devices. It complies of different subsections and here below we summarise the most significant requirements:

Materials, preformed sterile barrier systems and sterile barrier systems

Section 5 of ISO 11167 describes the requirements for Materials, preformed sterile barrier systems and sterile barrier systems. First of all, let’s clarify the difference between preformed sterile barrier system and a simpler sterile barrier system:

  • sterile barrier system : minimum package that minimizes the risk of ingress of microorganisms and allows the aseptic presentation of the sterile contents at the point of use.
  • Preformed sterile barrier system : sterile barrier system that is supplied partially assembled for filling and final closure or sealing.

The choice of the material to be used for a sterile barrier system or a preformed sterile barrier system is of foundamental important. Different parameters shall be evaluated for the material or the sterile system, such as temperature, pressure and humidity range, exposure to UV, cleanliness, bioburden.

The properties of the material and/or (preformed) sterile barrier system shall be carefully evaluated, including:

  • microbial barrier
  • biocompatibility aspects
  • physical and chemical attributes
  • compatibility with sealing and related process
  • compatibility with the sterilisation process
  • shelf-life limitations for pre-sterilization and post-sterilisation storage.

Properties of Microbial Barriers and Compatibility with Sterilisation Process

According to ISO 11167, microbial barriers shall be tested to ensure their ability to block the passage of microorganisms. There is no universally recognised test method for the evaluation of the property of the microbial barriers.

Of course, compatibility of the materials and of the barrier system with the sterilisation method shall be performed. This evaluation shall be performed in the framework of the validation of the sterilisation process, which might vary substantially based on the sterilisation system used, the type of product and other factors.

Design of Packaging system according to ISO 11167

The design of packaging system shall follow a documented procedure and multiple factors shall be taken in consideration for an efficient and appropriate packaging design process:

User Requirement and User Environment
The mass of the device and the configuration
Sensitivity of the product to particular risks such as radiation, mechanical shock, etc
Packaging labelling requirements
Environmental limitations
Storage Conditions
Sterilization Compatibility

Packaging Change and Revalidation

Based on ISO 11167, change control process hall be in place to ensure any change is evaluated and the necessity to report validation shall be documented. Re-validation shall be performed when the change is affecting packaging, sterility, safety or efficacy of the sterile medical device. Minor changes, instead, shall be documented and a review of the validation status shall be performed.

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