8 Key Steps to Packaging Integrity in the Medical Industry

Packaging integrity is a package’s ability to keep its contents safe and protected from potential damages, which include chemical, microbial, and physical threats.

Packaging integrity helps to safeguard patients’ safety and health. Proper packaging of biotechnology products, medical devices and pharmaceuticals is critical in the provision of healthcare services. Below are a number of steps you can follow to ensure packaging integrity:

1. Identify the Integrity Requirements or Regulations

A thorough understanding of a product is important before you start evaluating the packaging options available to you. What you need to establish are the performance criteria a medical product needs to meet such as shelf life and other functional requirements. Some of these performance metrics include barriers to protect the product from gases, moisture, etc.

You will also need to factor the efficacy, safety, sterility, and stability of the product. Other factors include the integrity of both the package and the product with a view to establishing the appropriate distribution dynamics. Lastly, product stability also requires appropriate temperature control inside and outside the packaging. A packaging design that ignores these requirements will compromise the integrity of the medical products.

2. Define Packaging Objectives

First, establish the objectives and capabilities of your packaging. The intended use of a package has a direct influence on its design and handling. For instance, let’s say you want to modify the design of your package so as to accommodate a new product. One question to ask yourself is whether the existing equipment can handle it. If it cannot, consider the cost and time implications in terms of installation, testing, money, and commercial runs, among other factors.

3. Define Storage and Distribution Factors

Once your healthcare product leaves the distribution centre to start the journey to a customer, physical and environmental challenges will invariably crop up along the chain. To arrive safely, considerations such as altitude, temperature, transportation mode, and the container it travels in are critical.

Besides the primary package, there are secondary and other protective packaging options you require so the product can reach its destination in good shape. Find out what variables such as humidity, vibration, shock, or pressure your medical product is sensitive to. Finally, find out what the export and import requirements are, including customs regulations, before shipping your product.

4. Undertake a Risk Assessment Exercise

Understanding the risks your product is exposed to help to mitigate the possibility of their occurrence. A risk assessment exercise will identify the negative issues that may negatively impact the package, product, or its usage. Consider hiring a risk management consultant to mitigate potential risks, or at least minimize their impact should they happen.

5. Create Package Design Prototypes

To start evaluating the integrity of your package, create a design prototype. If you cannot do this yourself, seek the assistance of packaging suppliers or other firms with design prototyping experience. There have been great strides in design prototyping in the last decade.

Today, there are 3D printers and efficient prototyping technologies that allow you to experiment with various models before commissioning bulk package production. Besides helping you make a decision on the ideal design, you can also use the prototype to test the market by exposing it to a carefully selected pilot group for feedback.

6. Test Package Integrity

To test the integrity of your package, expose it to a number of conditions to establish if there are possible protection gaps. Test the package for leaks, gases and moisture content, temperature dynamics such as humidity and vacuum, sterility, and conditioning by simulating its storage, handling and distribution.

7. Refine the Package Design

After doing a risk assessment, meeting regulatory requirements, and receiving feedback on the prototype, you are now ready to refine and mass-produce your package.

8. Verify the Performance Integrity of Your Package

This is the last step. The aim is to ensure the package has passed every performance criteria to ensure the integrity of your product throughout its shelf life.