Similar to how pharmaceutical packaging is vitally important when it comes to protecting the fragile contents inside, medical device packaging is almost as important as the actual device itself.
This is because packaging for medical devices plays a crucial role in safely delivering specialised treatment to those who need it. Patients need to feel assured that their treatment is safe and has remained sterile throughout storage, handling, and transportation.
Failing to properly package a pharmaceutical or medical product can result in a loss of sterility, product damage and diminished product performance. This can then lead to costly market delays, financial penalties, and reputation damage – basically situations no company would want to deal with!
In this article, we will be exploring the importance of medical device packaging, including information about the different types, and indicating some of the common mistakes that are made that should be avoided.
The different types of pharmaceutical and medical device packaging
Let’s start with the basics. As you’ll know, pharmaceutical and medical device packaging is varied and complex. However, it is mainly dominated by three types of packaging which include:
- Medical (WIP) trays: allow pharmaceutical companies and medical device manufacturers to safely store and transport products together. WIP trays can also be used for the final delivery of pharmaceutical and medical devices such as syringe barrel trays or electrical components.
- Pharmaceutical packaging for prescription and over the counter distribution: encompasses packaging that contains OTC pharmaceutical products or drugs. Pharmaceutical packaging helps protect the products from damage and contamination during shipping.
- Sterile barrier medical device packaging: this packaging is for medical products such as heart transplant kits, chemotherapy kits, and catheters that require sterile barrier medical device packaging as it protects medical devices during sterilization, shipping, and during use in hospitals. Implantable products such as diabetes drug delivery devices also require this type of packaging for protection. Popular types of medical device packaging include – peel pouches (most popular as it’s one of the most cost-effective ways of packaging disposal for medical devices) foil sachets, barrier packaging and thermoformed blisters and lids.
Important specifications of pharmaceutical and medical device packaging
Pharmaceutical and medical device packaging need to meet strict specifications in order to ensure patient safety. Medical packaging must have rigorous testing procedures to test requirements and specifications.
Ensuring the packaging has minimum thickness is often a vital specification for pharmaceutical and medical device packaging. This is because three common sterilization processes such as ethylene oxide sterilisation, gamma sterilisation, and autoclave sterilisation, kill all forms of bacteria and are harsh on plastic materials used in packaging. So, in order to ensure the packaging maintains its sterility and physical properties, minimum thickness is required. If it isn’t, the sterility of the packaging is compromised and so the sterility of the device will be considered unsuitable as well.
So, what amount of thickness is acceptable? Most packaging has a minimum thickness of 0.005 inches but testing sometimes shows that a minimum of 0.003 inches or even 0.010 inches is considered to be okay to use.
Sturdy seals are also- of course - vitally important and must have the strength to hold the items and not become undone as this would risk contamination to the medical products or devices.
Good medical device packaging needs to arrive at the destination free from holes, tears, or missing seals. It must also be able to remain for years in storage without the drug or device having their composition altered.
Common mistakes to avoid with medical device packaging
The lack of good quality medical device packaging can lead to serious problems for both the company and its customers. Some common mistakes that companies make when developing packaging for medical devices include:
- Losing sterile integrity: A frequent defect in medical packaging that can occur due to fractured thermoforms, slits, cuts, pinholes, and tears in the packages. The defects are usually the result of mishandling, vibrations during transportation, or from an impact caused by dropping the package. To avoid this, it’s always good to use the appropriate labels on your medical device packaging so that couriers know they should be handling the packaging carefully with extra caution.
- Not testing medical device packaging: Another mistake made is that some manufacturers fail to test their medical device packaging. This means they try to validate their packaging in the cheapest and fastest way possible, rather than through using reliable scientific practices.
- Using the wrong packaging size: Determining the right size for the medical device packaging can be a challenge. The most common mistake people make is having a package too small so that the package does not fit the product as this can compromise protective properties. To avoid this, take time to consider all the factors including how many samples will be delivered in the package, the size of the product that it will contain etc.
- Using the wrong material: This can happen in any industry when it comes to choosing packaging. With medical device packaging, it can usually be avoided if pre-qualification of the packaging is done at an early stage. Some examples of what goes wrong when using the wrong packaging material include the fracturing of thermoform trays because of using the wrong plastic material for the product and the product being too heavy for the impact resistance of the plastic.
- Squeezing oversized pouches into cartons: Squeezing pouches into cartons too small can cause defects. These defects can be reduced by having a carton that is just the right size so that the pouch can be inserted without folding, wrinkling, or creasing the ends.
Pharmaceutical and Medical device packaging from Swiftpak
At Swiftpak, we have over 40 years’ experience in the pharmaceutical and medical industry and hence can help you avoid the most common pharmaceutical and medical device packaging mistakes. Additionally, our in-house packaging designer can construct the perfect package for your product, ensuring your fragile items remain safe.
We understand that your medical products and devices are highly sensitive so we ensure our packaging provides exceptional protection and security with the high-quality presentation your brands deserve.