Sterile vs. Non-Sterile Medical Device Packaging
When should you use sterile medical device packaging as opposed to non-sterile options? Medical device packaging requires stringent safety protocols. These protocols ensure the safety and efficacy of medical products.
Manufacturers must adhere to strict regulations on packaging, labeling, and sterilization processes.
In this guide, we will explain the differences between sterile vs. non-sterile packaging. You will be able to identify which option to use depending on its application. Read on to learn more.
What Is Sterile Device Packaging?
Sterile medical device packaging protects a product against contamination. It provides a barrier between the device and its environment. It is often used for invasive, implantable, or single-use items that come into contact with human tissue or fluids.
Sterile devices are often packaged in materials such as foil bags, Tyvek pouches, and rigid containers. The material must have low permeability to water vapor and air. This helps to prevent microorganisms from entering the package.
Gamma irradiation or ethylene oxide gas sterilization techniques help prevent contamination before sealing.
What Is Non-Sterile Device Packaging?
Non-sterile medical device packaging protects products from damage during shipping and storage. They are often used for diagnostic or non-invasive products, such as stethoscopes, bandages, and thermometers.
Non-sterile packaging is made with materials like:
- Paperboard boxes
- Plastic trays
- Shrink wrap
- Stretch film
- Bubble wrap
- Plastic Tubes
- Plastic Extrusions
These materials do not provide a barrier against microorganisms, so you cannot sterilize them before sealing.
What Are Plastic Extrusions?
Plastic extrusions are a type of non-sterile medical device packaging. They are used to package catheters, stents, and other minor medical products. Plastic extrusions provide an easy way to store and transport devices without the risk of contamination.
They come in various shapes and sizes depending on the product they package. They also feature a unique seal that is tamper-evident and helps keep the product sterile.
For example, thin-walled plastic extrusions provide a secure barrier while allowing the product to be easily removed from the packaging.
How Long Can You Store Medical Devices?
The shelf-life of a medical device will depend on its type and design. Most medical devices are good for 2-5 years if stored in their original packaging.
To extend shelf life, manufacturers should follow best practices such as:
- Maintaining temperature control
- Avoiding direct sunlight
- Protecting the product from moisture and dust
How Is Sterile Packaging Done?
The Aseptic process is a packaging method that uses sterile materials and sterile conditions to maintain the safety of packaged products. This process is used for products that are sensitive to heat or chemicals. It helps to extend the shelf life of these products.
The Aseptic process begins with cleaning and sanitizing the product. The product is then sterilized with a chemical or physical process. Once the product is sterilized, the package is prepared and tested.
The package is then filled with inert gas, such as nitrogen, and vacuum-sealed. The package is labeled and tested. The Aseptic process is a safe and effective way to ensure the quality of sensitive products.
Medical Device Packaging Sizes and Shapes
Medical device packaging comes in a variety of sizes and shapes. This includes:
- Blister packs
- Foil pouches
- Resealable bags
- Glass jars
It is important to use the correct size and shape for each product, as this will prevent damage during shipping. Non-sterile kits are also available for products that require multiple components. These kits come with instructions, labels, and packaging to ensure the safe delivery of all parts.
Types of Sterile and Non-Sterile Kits
Single-use kits are for products that you use once and dispose of. These kits contain sterile packaging, instructions, labels, and other components that protect the product from contamination.
Multiple-use kits are for items you use multiple times with proper cleaning and sterilization. These kits include a central container with multiple compartments, labels, and other components.
Sterile kits come in a variety of types depending on the product they package.
Gas barrier bags provide an airtight barrier that prevents contamination while allowing products to be easily removed from the packaging. Vacuum-sealed bags create a vacuum within the package and reduce the risk of contamination.
Clamshells are two-part plastic containers that can be used for both sterile and non-sterile products. They provide a secure packaging solution and allow easy access to the product inside.
Types of Non-Sterile Kits
Non-sterile kits are for items that do not require the same level of protection as sterile products. These kits come in a variety of types as well.
Plastic bags are an economical and convenient way to package small products. They protect from dust and moisture but are not suitable for long-term storage.
Cardboard boxes provide a secure and protective packaging solution for products of all sizes. You can also print product information and instructions on them.
Tubes are a great option for packaging liquids and powders. They protect the product from contamination, provide easy access to the contents, and can be customized with labels.
Extrusions are a great way to package long, thin products. These packages protect the product from dust and moisture while providing easy access to the contents.
Petro Packaging Inc.
Experts in the making of Plastic Tubes and Extrusions for the medical industry, Petro Packaging has been providing solutions to customers since 1965. We strive to offer products with the highest quality and innovation.
Our clear eco-friendly packaging uses the following quality materials:
PETG is a thermoplastic polyester that is commonly used in manufacturing medical device packaging. It is strong and durable, making it ideal for protecting products during shipping.
It is also moisture-resistant and does not allow bacteria to grow. PETG is available in a variety of sizes and shapes, making it suitable for use with many different types of medical devices.
CAB (cellulose acetate butyrate) is another thermoplastic that is often used in medical device packaging. It provides excellent chemical resistance and does not become brittle over time.
It is also FDA-approved, making it an ideal choice for medical device packaging. CAB is available in a variety of sizes and shapes, making it suitable for use with many different types of products.
CAP (polycaprolactone) is a thermoplastic elastomer commonly used for medical device packaging. It has excellent strength and flexibility, making it ideal for protecting products during shipping.
It is also moisture-resistant and does not allow bacteria to grow. CAP is available in a variety of sizes and shapes, making it suitable for use with many different types of medical devices.
Source Quality Medical Device Packaging Made in the USA
Sterile vs. non-sterile medical device packaging has different requirements and applications. Sterile medical device packaging protects against contamination. Non-sterile devices simply protect the product from external damage.
It is important to understand the differences between these types of packaging so you can choose the right one for your product. Petro Packaging offers quality, U.S.-made plastic tubes, and extrusions that meet all non-sterile medical packaging standards. Contact us today to find the solution you need for your products.