Medical Packaging Film

Medical packaging films are made of materials like polyethylene, polypropylene, and specialized polymers to create a barrier against contaminants. These films are essential for maintaining the efficacy of medical supplies and can help prolong the shelf life of healthcare products, pharmaceuticals, and medical devices. Medical packaging films can be used in many medical applications, including Disposable surgical gowns, Mattress covers, Fluid bags, Transdermal patches, Wound-care products. These films are designed to provide an extra layer of protection against environmental factors such as oxygen, moisture, UV light, and other factors.

Medical pouch packaging is a proven solution for medical devices. In addition to being lightweight, portable, and easy to store, medical device pouches aid in maintaining product sterilization, protection, and safety. Medical pouches are versatile, and it’s tempting to think of them as one-size-fits-all. The reality is that medical pouch packaging is crafted to accommodate the specific features of medical devices.
Medical pouches are constructed by pairing two webs of materials and heat sealing them on three sides. The remaining opening is heat-sealed after device insertion.

Breathable
Porosity is the key to breathable pouches. Therefore, at least one web is made using coated paper. Breathable pouches withstand EO sterilization and are generally used for applications requiring a high level of disinfection. The porous web maintains product sterility while still offering the breathability needed, and can also be helpful in instances where pressure or altitude changes are a concern.
Breathable pouches are versatile and typically have a chevron or corner peel opening feature. They are used for a range of devices such as catheters, gowns, wound-care products, orthopedics, syringes, diagnostic devices, and cardiovascular applications.

Film-to-film
Extrusion films address a wide range of package integrity needs, from EO and E-Beam microbial barriers to safe, simple aseptic access. We provide polyolefin and nylon thermoforming solutions, while Standard Medical Laminates are strong, multi-layered proprietary sealant films. Both are ideal for pairing for safe, reliable peel-open packaging systems.
Film-to-film pouches are commonly used for situations where enhanced product protection and visibility is required. Material combinations range from basic options for lightweight devices to more premium constructions for heavier products that need puncture resistance. Combinations can be offered as peelable or non-peelable depending on end user needs, and most combinations are compatible E-beam and gamma radiation sterilization methods. Syringes, orthopedics, endoscopic devices, tubing sets, and procedure kits are several examples of the applications appropriate for film-to-film pouches.

High Barrier
To maximize shelf life, sensitive medical devices must be shielded from light, oxygen, and moisture. To accomplish this, high barrier pouches combine films, foils, and barrier coatings. Barrier pouches are typically used for applications such as cardiac catheters, guidewires, implants, diagnostics, and drug-coated products, but are not limited to these market end-uses. Similar to film-to-film pouches, these pouch combinations can be offered in peelable or non-peelable formats and various degrees of performance options.
In addition to categorization, pouch materials dictate medical device sterilization capabilities. Likewise, the materials chosen play a role in compliance. Pouches must comply with ISO 11607 requirements for sterilization, microorganism contamination prevention, and aseptic presentation.

Many medical products depend on medical polymer films, an essential component in medical packaging, to protect against contaminants and maintain the products’ integrity. Medical polymer films also inhibit or enable the circulation of air, as well as guard against light, moisture and other gases. Common types of medical film materials:
●Single films
●Laminations
●Coextruded films
Laminations are comprised of two or more individual films, typically featuring the best properties of each film in the final composite. Laminations are very stable, and are often used to manufacture pouches. Materials used to create laminations include polyethylene-cellophane, polypropylene-cellophane-polyethylene and polyethylene-polycarbonate.
Whereas laminations require individual layer fabrication, coextruded films simultaneously manufacture multiple layers. Coextruded films are sometimes used in place of adhesives and coatings. Typically, coextrusion films can be made from high-density polyethylene, polystyrene, polypropylene, or polyvinyl chloride. Most coextruded films are impermeable by gas, which enables their use as packaging for sterile products. Our material is commonly used for packaging products that have been gas-sterilized, such as gloves and wound dressings.

●Polyethylene Terephthalate (PET)
PET is a transparent, relatively low-cost film popular for product packaging. It is one of the most widely recycled plastics in the world. Untreated, it offers a moderate oxygen barrier, good moisture barrier, and high heat resistance. It is a good general-use material.
PET film can also be coated on one or two sides to allow lamination, metalizing, etc. Treating provides adhesion for inks and lacquers. Metalized PET offers excellent barrier properties for oxygen and moisture and can help to extend product shelf life. For an even greater shelf life, an aluminum oxide coating can be used.
Post-consumer recycled (PCR) PET is made from recycled PET. When made with 90% PCR content, it has the same properties as Non-PCR PET.

●CPP (Cast Polypropylene)
CPP film offers optical clarity while remaining cost-effective. It also features good seal strength, and it can resist tears and punctures. It can be used for hospital bags, device strips, and many other purposes.

●Fluoropolymers
Offering stability in high temperatures, fluoropolymer plastic films are used in the medical industry. Made of multiple carbon-fluorine bonds, the materials also resist friction, corrosion, and many chemicals. Fluoropolymers are commonly used for medical catheters, vascular access sheaths, and shrink tubing.

●HIPS (High-Impact Polystyrene)
A versatile option, HIPS can be used for many general purposes within the medical industry. These plastic films are frequently used for medical-purpose petri dishes, waste canisters, and other general uses.

●Oriented Polypropylene (OPP) and Biaxially Oriented Polypropylene (BOPP)
OPP is polypropylene that has been stretched in one direction, while BOPP has been stretched in two directions. This stretching produces a glossy, transparent film that can run on most packaging lines. BOPP is easy to coat, print, and laminate and offers a better moisture barrier to PET, although it is a poor oxygen barrier.
OPP matte has a matte, paper-like appearance. Graphics printed on the film are translucent, but it offers the same protection as OPP. OPP clear barrier film offers improved OTR over standard OPP.

●Nylon
Nylon is a strong material that offers puncture resistance. If you have a sharp product, like pasta, nylon is the material to consider. It offers heat resistance and is a moderate oxygen barrier.

●Metallocene Linear Low-Density Polyethylene (MLLDPE)
Metallocene LLDPE is a derivative of LLDPE but offers excellent impact and puncture resistance. It has heat seal properties, making it a high-performance film useful for food and pharmaceutical applications. When mLLDPE is co-extruded with ethylene vinyl alcohol (EVOH), the film provides oxygen barrier.

Selecting the appropriate packaging for medical devices requires a full understanding of performance and application requirements to uphold both functionality and safety. When starting the packaging process, there's a myriad of considerations, each crucial in preserving the device's integrity. From dimensions to sterilization methods, here’s a breakdown of what you should consider when choosing your medical packaging.

Size, Weight, & Geometry
Medical devices come in all shapes and sizes. Understanding your device's size and weight is imperative to secure protection—from big and bulky to small and sleek. Packaging that is under or oversized can put you at risk of a breach in the sterile barrier. Punctures, seal creep, and flex cracking are failure modes, to name a few, that can occur when a package is under stress. Device geometry is also an essential input when it comes to potential packaging defects. Recognizing any rough edges or sharp components is necessary to ensure the correct packaging materials are used. Negligence to this factor can, again, put you at risk for packaging failures and a breach in the sterile barrier system. For example, if you are designing a package system to protect against a sharp device, one solution that may be considered is using a tougher material such as a nylon pouch.

Aseptic Presentation
Aseptic transfer techniques are used by healthcare professionals to prevent exposure of a sterile device to microbial agents. It’s important to consider usability and whether your packaging needs to be torn or peeled open.

Sterilization
Sterilization is often the first thing people think about when they think of medical packaging. The sterilization method (modality) plays an important role not only in ensuring a clean device is delivered—but also in packaging material decisions. It’s important to know what kind of modality is necessary and whether or not a breathable substrate is required.

Distribution
What distribution channels will be used when shipping your product? Consider climates and altitudes that the device may be exposed to in transit. Understanding distribution hazards early in the development process and designing both your primary and secondary packaging to protect against those hazards, will mitigate potential test failures downstream.

Barrier
Have a device that’s sensitive to moisture, oxygen, and/or light? No problem. Choosing the right barrier laminate can help. Barrier films for sterile barrier packaging are typically structured with multiple materials that meet various protective and functional requirements. Aluminum oxide layers protect against unwanted moisture and oxygen exposure. Aluminum foil offers the same protection, in addition to light exposure. The full laminate structure can then be chosen based on other needs, such as nylon for added puncture resistance, and sealant layers that are compatible with other pouch films or tray substrates.
From shielding against sharp edges to safeguarding against environmental factors, the path to finding the right medical packaging has crucial decisions at every step of the way. By meticulously considering these factors, selecting the ideal medical packaging culminates in protecting the device—and ultimately patient safety.