Choosing the right plastic material to hold a medical device is critical to ensure the product arrives to the practitioner and patient safely. In this case, it’s what’s on the inside of the outside that matters most.
Each material has different characteristics, properties, and strengths that make them ideal for different applications. Some materials are more suitable for heavy-duty applications, while others provide excellent clarity, which is essential for the visibility of the packaged device. Factors influencing material selection include performance, appearance, cost, durability, and compliance with sterilization methods. By evaluating project parameters, Brentwood’s engineering team can help choose the most cost-effective material to meet packaging goals and regulations.
PETG (Glycol-Modified Polyethylene Terephthalate)
One of the most widely used materials for medical thermoformed tray packaging is PETG (glycol-modified polyethylene terephthalate). This transparent material allows for easy visibility of the packaged medical device, a crucial factor in applications where quick identification is necessary. PETG provides a balance of toughness and resistance that helps protect delicate medical devices during transportation and handling.
It is also compatible with common sterilization methods such as ethylene oxide (ETO), radiation, and gas plasma, ensuring its structural integrity across diverse sterilization processes. Additionally, PETG accommodates complex designs and deep-draw processes without compromising strength, making it an ideal candidate for medical packaging.
HIPS (High-Impact Polystyrene)
Another commonly used material is high-impact polystyrene (HIPS), a versatile and cost-effective option. Though it lacks transparency, HIPS offers significant advantages in medical device packaging, including impact resistance that protects medical devices during transportation.
It can withstand sterilization methods like ETO, radiation, and gas plasma while maintaining the shape and structural integrity of the packaging. HIPS can also be easily thermoformed into complex shapes, allowing for customized designs tailored to specific medical device packaging needs.
PETG Foam
PETG foam is another material option that provides a clean and durable alternative to HIPS for opaque product applications. It consists of PETG outer layers for improved sealing and a PETG foam core that enhances impact resistance and density. This multilayer composition improves protection against environmental factors, making PETG foam a reliable choice for demanding medical packaging environments.
The increased density of the foam core enhances shock absorption, safeguarding delicate devices during transit. Its strong sealing properties also help maintain sterility, which is crucial for preserving the integrity of packaged medical devices.
PP (Polypropylene)
Polypropylene (PP) is a cost-effective and highly versatile material that features high flexural and impact strength, anti-static properties, and good moisture resistance. It can be produced in different formulations, including clarified versions for enhanced transparency. Polypropylene is compatible with sterilization techniques such as gamma and steam sterilization, making it an ideal choice for healthcare applications where maintaining sterility is essential. Additionally, its lightweight nature contributes to reduced shipping costs without compromising protective qualities.
PC (Polycarbonate)
Polycarbonate (PC) is known for its high-impact strength and stability, making it ideal for packaging that requires higher-temperature sterilization methods like steam. Its superior durability ensures the safety of fragile devices, even under extreme environmental conditions. Despite its higher cost, polycarbonate remains a top choice for applications where performance and safety are non-negotiable, providing unmatched protection against contamination and mechanical stress.
APET (Amorphous Polyester)
Amorphous polyester (APET) is another commonly used material in medical packaging. While it is primarily seen in food and consumer packaging, it is sometimes used for lightweight, pouched medical trays with mild sterilization processes. APET offers a lower-cost alternative to PETG while still providing good visibility. It is best suited for applications that do not require intense sterilization methods, as extreme heat exposure can compromise its structural integrity.
HDPE (High-Density Polyethylene)
High-density polyethylene (HDPE) is a strong and stiff material with good impact and abrasion resistance, making it a reliable choice for medical device packaging. While its milky appearance limits its use in applications requiring transparency, this characteristic makes it a cost-effective option for budget-conscious manufacturers. HDPE’s resistance to chemicals and moisture ensures sterility and protection, making it ideal for securing medical devices throughout their lifecycle.
Considerations
With so many materials to choose from, trying to decide which plastic to use can seem like a daunting task. Some ideas to take into consideration when making your decision may include:
- Cost
Like everything, each material comes at a cost. Knowing your budget, you may be able to narrow down your material options.
- Durability
Ask yourself how far the product needs to travel. If it’s to be used in multiple facilities and across the country, the chosen material needs to be able to withstand the rigors of transportation, handling, and storage, maintaining its integrity throughout the process. Conversely, a more pliable material may be used if the device does not need to travel as far.
- Clarity
Those producing the medical device need to ask themselves if it is important for the product to be visible to the outside world. If so, a clear package material will be important.
- Longevity
The material must remain effective throughout the intended shelf life of the device, resisting degradation and retaining its protective properties as long as the device needs to be enclosed within the packaging.
- Regulatory
Given the stringent health and safety regulations governing the medical industry, all standards must be met. Adhering to these standards is essential not only for product safety for patients but also to ensure market access for these products and to avoid costly recalls or legal issues.
Partner With Us
Brentwood’s engineering team specializes in designing parts and selecting the optimal material to meet medical packaging needs. If you need assistance choosing the right material for your medical device packaging, start a conversation with one of our designers today to ensure your product meets both performance and regulatory requirements.
0 Comments