The medical device manufacturing industry needs to take careful measures and precautions when it comes to their product’s packaging. Poor medical-purpose packaging can cause a number of problems for both the manufacturer and customer, as any broken, damaged or unsterile packaging could compromise the product’s opportunity of making it onto the shelf, not forgetting the end user’s safety.
If you’re looking to review your product’s packaging, here are a few things to consider.
Firstly, you will need to decide on the most suitable packaging material and design for your medical device. The majority of medical devices are packaged in a type of tray or pouch – typically made from foil, polymer or polyethylene. Trays tend to be more aesthetically-pleasing and provide more protection, but are a little more expensive, whereas pouches are the cheaper and quicker option if you’re looking to reduce lead times and save costs on production.
Improperly-sized packaging elements can also result in loss of integrity. If the packaging element does not fit the medical device properly, this could result in excessive movement within the packaging; which could damage the product.
The material must also be robust enough to withstand shipping through all types of climates or physical hazards. Types of packaging elements that need to be considered include the tray or pouch, backer card, lids, shelf carton and shipping container.
There are several sterilisation methods for medical devices – the most common being electron beam (E-beam), ethylene oxide (ETO) and autoclave. For any sterilisation method, you should select a material that will allow the sterilant to penetrate the product. For example, sterilisation methods that include steam or gas, a material that is porous enough for the vapour to penetrate the product is required.
We recommend testing the sterilisation process during a validation phase, as this will ensure the sterilisation process you’ve selected doesn’t break down the material or cause a change in colour to the packaging or device.
The industry-standard ‘ISO 11607: Packaging for Terminally Sterilised Medical Devices’ outlines all of the package validation testing requirements for medical devices, including seal integrity and strength, material integrity, distribution testing, shelf life and aging of the packaging.
Testing must be factored into the planning stage of any medical device packaging, as some lead times can be as long as 6 months, particularly in aging tests, as this will be dependent on the desired shelf life of the product.
Any packaging must be fully assembled and sterilised, as it would be for the market, before carrying out any testing to give a real-life, accurate result.
Whilst the packaging integrity and shelf life standards are covered in ISO 11607, sterilisation has different standards depending on the chosen method. The validation processes will establish the Sterility Assurance Level (SAL).
The gamma and E-Beam sterilisation methods follow ‘ISO 11137: Sterilisation of Health Care Products’, where the sterilisation dosage is set by the product’s bioburden and the desired SAL. Bioburden is the amount of bacteria on the product as a result of the manufacturing process.
SAL is the probability that a unit subjected to sterilisation remains non-sterile. The most common SAL is 10-6 or a 1 in 6 million chance of a non-sterile unit, and is typically what most hospitals require of most medical devices, except for certain types of biological implants where there are exceptions.
In addition to sterilisation validation processes, a quarterly audit is usually carried out to ensure that the manufacturing process continues to produce sterile devices and adhere to the ISO standards.
Due to the various planning, design and testing aspects required for medical device packaging, we advise working with experienced packaging professionals who are confident with the appropriate testing procedures and industry requirements.
Paramount Packaging Systems provide medical device packaging systems which are designed to maintain the sterilisation of a product and are compatible with a variety of suitable materials and pack styles to meet your needs.
Looking to review your product’s packaging? Discuss your project with our team by calling 01252 815 252. Alternatively, click here for more information.