Medical device packaging: using heat sealers to package medical devices

Medical device packaging can take many different forms. However, in this month’s blog, we are going to be looking at medical device packaging using heat sealed or vacuumed thermoplastic bags. There are number of things to consider if you want to go down this route of medical device packaging. Let’s take a closer look:

Decide which material you want to use for your medical device packaging

Probably the most important question to ask is: what material do I want to use? A wide variety of different materials can be used for the bags. Often medical device manufacturers or people in the life sciences sector have very unique requirements for packaging. Aluminium foil and clear plastic bags, as well as composite plastic/Tyvek® pouches are just some examples. In fact, the types of materials and way of packaging medical devices is enormous.

Once you have decided on your material, you will need to ask yourself a few more key questions before deciding on which heat sealer to go for.

Other questions to consider for your medical device packaging

Below is a list of key questions you should answer before looking to package your medical device:

• What form will the material be in? For example, are you planning to use pouches or reels?       
• What are the dimensions of the pouches or reels?
• What kind of product are you planning to pack?
• What is the size and weight of the product?
• Should the sealer be installed in a clean room (i.e. be of clean room class)?
• Is compressed air available in the cleanroom?
• Do you need a cleanroom measurement certification for your equipment?
• Is a validated sealing process required?
• Do you want to record the sealing process?
• Do you need a vacuum? Will this be needed to fix the product in one place?
• Does the product need to be sterilised after packaging?
• If yes, which kind sterilisation is needed?
• How many pouches do you want to seal per hour/day/week/month?  

Normally, most of these questions can be found in the a detailed User Requirement Specification (URS). If you do not have a URS, you should create one before going any further. This will help any potential supplier understand what your expectations are.

Once you have decided on what material to use and answered the questions above, you can now look at what options there are heat sealers.

Industrial bar heat sealers

Industrial bar heat sealers work in the same way a regular heat sealer would work. They are available in a range of different widths depending on the size of the bag you want to seal. Heat and pressure are applied to seal a medical device inside a bag. Manufacturers such as Hawo make a wide range of industrial heat sealers perfect for packaging medical devices or for use in the general life science sector.

These heat sealers are designed for heavy use and their robust, all-metal construction reflects this.

Vacuum bar heat sealers

Vacuum bar heat sealers are exactly the same as the industrial bar heat sealers, except that there are integrated nozzles which suck the air out before sealing the bag. Sometimes, there are just two nozzles and other times there are four. Additional nozzles can speed up the process of the vacuum or they can be used for gas flushing if this is needed. For example, Hawo’s hv range of heat sealers are ideally suited to sealing bags when a vacuum and/or gas flushing is required.

Vacuum sealer machine

Vacuum sealer machines like Hawo’s hv 321 K-V MediVac are perfect for medical device manufacturers who want to expel 100% of the air from the packaging. This is needed when contents need to be in airtight packaging. Whilst a standard vacuum bar heat sealer will only suck out around 85% of the air, a vacuum sealer machine will expel all the air in the bag.

The downside of this is that the vacuum process can take between 30 seconds to 1 minute. This is actually quite a long time if you are packaging thousands of medical devices. Therefore, it may not be suitable for large scale packaging.

The Hawo hv 321 K-V MediVac allows the user to create GMP compliant packaging and the sealing process can be validated to EN ISO 11607-2. This makes it an ideal choice for packaging not just medical devices, but also industrial products such as semiconductors and other electrical components.

How Henderson Biomedical can help

Henderson Biomedical is the UK distributor of Hawo heat sealers. Hawo manufacture a range of heat sealers used for the packaging of medical devices. We can give you first-class advice on what options are available to you and how we can help with your medical device packaging needs.

You can also send us samples of the packaging that you intend to use and we can advise you on which heat sealer may be appropriate. We would be happy to conduct free-of-charge tests on the material you wish to heat seal to trial it and see if our products will be suitable.

For more information on how we can help you, please contact us on 020 8663 4610, emails us at info@henderson-biomedical.co.uk or use our online form and a member of the team will get back to you.