Seal Strength Testing: Ensuring Safety and Quality 

Oct 15, 2023 | Blog, CeraTek

Packaging is not just a protective layer; it’s a critical component that can directly impact patient safety and product integrity.

A secure and reliable seal prevents contamination, maintains sterility, and preserves the efficacy of medical devices.

Seal strength testing is a crucial quality control step in the medical device packaging field, ensuring that seals meet the high standards necessary for the healthcare industry.

What is the purpose of testing the seal?

The primary purpose of seal strength testing is to verify that the seals on medical device packaging are strong enough to withstand various stresses and conditions during transportation, storage, and handling, without compromising the sterility and quality of the enclosed medical devices.

Seal Strength Testing Methods

Several methods are used to test the strength of seals in medical device packaging, including:

• Peel testing
• Burst testing
• Tensile testing

Peel Testing

Peel testing is a widely used method in the assessment of seal strength for various types of packaging, especially medical device packaging.

This method involves applying a controlled force to separate two sealed surfaces, typically at a 90-degree angle, simulating the process of opening the package.

Peel testing provides valuable insights into the integrity of the seal. It assesses whether the seal is uniform and consistent along its length, as an uneven seal can lead t

o weak points that compromise package integrity.

A well-sealed package should require a consistent and adequate force to open, ensuring the contents remain protected until intentionally accessed.

Beyond assessing the seal’s strength, peel testing also helps evaluate its resistance to tampering or unauthorized access. Peel testing helps verify that such tamper-evident features function as intended.

Burst Testing

This method assesses the package’s ability to withstand internal pressure changes without rupturing.

During burst testing, the sealed package is subjected to an increase in internal pressure. This pressure is gradually applied until the package fails, i.e., the seal ruptures. The pressure at which this failure occurs is recorded.

Burst testing is a critical quality control measure for packages that must maintain their integrity under specific conditions.

Tensile Testing

Tensile testing evaluates the strength of the sealed edges of a package and measures the force required to pull them apart. This method is essential for packages that require a strong seal to prevent accidental tearing or opening.

Tensile testing provides a quantitative measure of the seal’s strength along the sealed edges. This is particularly important for packages that need to withstand rough handling during shipping and distribution.

Packages holding fragile devices that need seals that are resistant to tearing or damage during transit. Tensile testing helps ensure the packaging can withstand these challenges.

The Significance of Seal Strength

Patient Safety

The primary goal of medical device packaging is to safeguard patients from contamination and infection.

A weak seal can lead to breaches in sterility, potentially causing harm to patients who rely on these devices for their health and well-being. 

Preventing Contamination

Medical devices often come into contact with sensitive areas of the body or are used in sterile environments, such as surgical procedures.

A weak or compromised seal on the packaging of these devices could lead to contamination, which may result in infections or complications for patients. Ensuring the integrity of seals through testing helps prevent such issues and protects patient health.

Regulatory Compliance

Medical device packaging must adhere to strict regulations and standards set in the medical field. Seal strength testing is often a mandatory requirement to demonstrate compliance with these standards.

Compliance with these regulations helps ensure that only safe and effective medical devices are available to healthcare providers and patients.

Seal strength testing is the key patient safety and product integrity in the medical device packaging field.

It ensures that medical devices are delivered to healthcare providers and patients in a safe and reliable condition.

By doing so, they not only protect patients but also their own reputation and bottom line, contributing to the overall betterment of healthcare worldwide. Contact our team today to learn more!

Heat Sealing in the Medical Field

Oct 1, 2023 | Blog, CeraTek

One often overlooked yet crucial aspect of medical device and packaging production is heat sealing. This unassuming process plays a vital role in ensuring the integrity of medical equipment and supplies, contributing significantly to patient well-being and the effectiveness of healthcare.

Let’s explore the importance of heat sealing in the medical field and how it impacts various aspects of healthcare.

What is Heat Sealing?

Heat sealing, also known as heat welding or thermal sealing, is a process that utilizes heat to create a hermetic seal on two or more thermoplastic materials. These materials can include various plastics, such as polyethylene, polypropylene, and PVC, as well as laminates and films.

It involves two main components: heat and pressure. The process involves the application of heat and pressure to the materials, causing them to melt and fuse together. Once the heat source is removed and the materials cool, a strong and secure seal is formed.

By applying heat to the edges or seams of two materials and exerting pressure, the materials bond together, creating an airtight and watertight seal.

This technique is widely used in the medical field for packaging, manufacturing, and assembly of various medical devices and equipment.

The Importance of Heat Sealing in the Medical Field

Sterility Assurance

One of the primary reasons for the widespread use of heat sealing in the medical field is its ability to maintain sterility.

Medical devices, surgical instruments, and pharmaceutical products must remain free from contaminants to ensure patient safety.

Heat sealing provides a reliable method to seal packaging materials, such as:

• Sterilization pouches
• Blister packs
• IV bags

And effectively prevent the ingress of microorganisms and maintain sterility until the moment of use.

Extended Shelf Life

Many medical products, such as diagnostic test kits, sutures, and catheters, have a limited shelf life.

Heat sealing ensures that these items remain sealed and protected from environmental factors like moisture, oxygen, and light that can degrade their quality.

This extends the shelf life of medical products, reducing waste and saving costs in the long run.

Tamper-Evident Packaging

In the medical field, tamper-evident packaging is crucial to detect any unauthorized access or tampering with medical supplies.

Heat-sealed packaging can include tamper-evident features, such as visible seals that break upon opening.

This provides a clear indication to healthcare providers and patients that the product may have been compromised and should not be used.

Packaging Integrity

For medical equipment like catheters, stents, and surgical drapes, the integrity of the packaging is paramount.

Heat sealing ensures that these products are securely packaged, protecting them from physical damage during transportation and storage.

This reduces the risk of contamination and ensures that medical professionals receive undamaged, reliable products.

Customization and Efficiency

Heat sealing technology allows for precise customization of packaging to accommodate various medical devices and shapes.

This versatility and efficiency in production are essential for medical manufacturers who need to adapt to a wide range of product sizes and designs.

Heat sealing machines can be adjusted to meet specific requirements, ensuring a seamless and cost-effective manufacturing process.

Heat sealing might not always be in the spotlight of the medical field, but its significance cannot be understated.

With the continuous advancement of medical technology, the importance of heat sealing in the healthcare sector will only continue to grow.

As medical professionals and manufacturers strive to provide the best possible care and products, the reliability and precision of heat sealing technology will remain an indispensable tool.

Contact one of our team experts to learn more about heat sealing and how it can be a vital addition to your business.

Exploring Medical Packaging Materials

Sep 21, 2023 | Blog, CeraTek

In the world of medicine, packaging materials play a crucial role in ensuring the safety, sterility, and integrity of pharmaceutical products and medical devices.

While the innovative treatments, cutting-edge surgical techniques, and life-saving medications developed by the medical community often steal the spotlight, the unassuming packaging materials quietly serve as the last line of defense against contamination, degradation, and potential harm to patients.

The Importance of Medical Packaging Materials

Medical packaging materials are more than just a means to encase products; they serve as a protective barrier that prevents contamination, maintains sterility, and extends shelf life.

Using the proper material saves patient lives.

These materials are designed to withstand rigorous transportation, storage, and handling conditions, all while safeguarding the contents within.

As medical advances continue to push boundaries, the demand for packaging that complements these innovations has never been more critical.

Among the most widely used materials in medical packaging, plastics, metals, and paper are particularly prominent. Within these categories, important options include:

Plastics: Versatile, Flexible, and Protective

Plastics are incredibly versatile and widely used in medical device packaging due to their unique qualities including

• Tamper-Evident features
• Transparency
• Cost-effectiveness

Here’s a closer look at some common plastics used in the industry.

Polyethylene (PE)

Polyethylene plastic is favored for its flexibility and ease of molding. It’s often used for packaging items like disposable gloves, syringes, and tubing. Its pliable nature allows it to conform to various shapes and sizes of medical devices.

Polypropylene (PP)

Polypropylene is known for its chemical resistance and strength. It’s used for a wide range of medical devices, from containers to surgical instruments packaging. Its robustness ensures the safety of the enclosed products.

Polyvinyl Chloride (PVC)

Polyvinyl Chloride is popular for medical tubing and IV bags due to its excellent flexibility and compatibility with sterilization methods. It provides a reliable barrier against contamination.

Metals: Strength, Durability, and Impeccable Protection

Metals offer unparalleled strength and durability, making them suitable for specific medical device packaging needs due to their qualities:

• Corrosion resistance
• High-temperature tolerance
• Longevity

Here are the two most common metals used in the industry.

Aluminum

Aluminum is a star in medical packaging, especially in blister packaging and foil pouches. It forms a protective barrier against moisture, gases, and light, making it ideal for maintaining the sterility and integrity of medications and sterile devices.

Stainless Steel

Stainless steel shines in applications where implantable devices and surgical instruments demand resilience. Its corrosion resistance and biocompatibility ensure long-term safety and durability.

Paper: Tradition Meets Modern Needs

Despite the proliferation of plastics and metals, traditional paper-based materials still have their place in medical device packaging. Paper is important to

• Maintain sterility
• Control moisture
• Provide breathability

 Kraft Paper

Known for its strength and durability, kraft paper is often used for packaging items like surgical gloves and drapes. Its natural appearance aligns with eco-friendly packaging preferences.

Tyvek

Although not a conventional paper, Tyvek deserves special mention. This synthetic material offers a paper-like appearance while delivering

exceptional durability. The permeability of Tyvek prevents the accumulation of condensation, reducing the risk of microbial growth and product degradation. It’s a trusted choice for maintaining sterility, preventing condensation, and reducing the risk of microbial growth.

Ultimately, the world of medicine relies heavily on packaging materials to ensure the safety, sterility, and integrity of pharmaceutical products and medical devices. While these materials may often go unnoticed, their role is paramount in safeguarding patient health and well-being.

Medical packaging materials are not merely containers; they are the protective barriers that stand between patients and potential harm. These materials are engineered to endure the rigors of transportation, storage, and handling, all while preserving the quality and safety of their contents.

The importance of medical packaging materials cannot be overstated. They are the silent guardians ensuring that patients receive the safest and most effective treatments and devices available.

As we look to the future, the continued advancement and innovation of these materials will remain essential to the continued progress of medicine and the well-being of patients worldwide.

Check out our heat sealing devices to learn more and discover the material that aligns best with your needs.

Types of Medical Device Packaging: Tray Sealers and Pouch Sealers

Sep 7, 2023 | Blog, CeraTek

Tray Sealers: Preserving Integrity and Functionality

Tray sealers are a popular packaging solution for medical devices that require protection. These machines are designed to encase products in custom-designed trays, ensuring a secure and tamper-evident seal.

Tray sealers offer several key advantages in medical device packaging.

Product Protection

Tray sealers provide a protective barrier that shields medical devices from external contaminants, physical damage, and moisture. This is crucial for devices that are sensitive to environmental factors.

Customization

Manufacturers can create trays of various shapes and sizes to accommodate specific medical devices. This customization ensures a snug fit, minimizing movement within the packaging and reducing the risk of damage.

Visibility

Transparent trays allow for easy visibility and inspection of the medical devices without compromising sterility. This is especially important for sterile devices that need to be examined before use.

Tamper-Evidence

Tray sealers can incorporate tamper-evident features, which provide a clear indication that the packaging has been opened or compromised. This feature enhances the security and safety of the packaged medical devices.

Efficiency

Modern tray sealing machines offer automation options, streamlining the packaging process and increasing production efficiency. This is vital for meeting high-demand requirements.

 Pouch Sealers: Versatile and Sterile Packaging

Pouch sealers are another essential tool in the medical device packaging landscape. These machines create airtight seals on flexible pouches, preserving sterility and ensuring product integrity. Pouch sealers bring several benefits to medical device packaging:

Sterility Maintenance

Pouch sealers create hermetic seals that maintain the sterility of medical devices until they are ready for use. This is vital for devices that need to remain sterile until the moment of application.

Flexibility

Pouches are available in various materials and sizes, making them adaptable to different types of medical devices. They are especially useful for smaller items or those with irregular shapes.

Easy Opening

Many medical pouches are designed for easy opening, often featuring tear notches or peelable seals. This convenience is crucial in healthcare settings where quick access to medical devices is necessary.

Portability

Pouches are lightweight and compact, making them ideal for packaging medical devices that need to be transported easily or stored in limited spaces.

Barrier Properties

Pouch materials can be engineered to provide specific barrier properties, such as resistance to moisture, gases, and UV light. This ensures the long-term stability of the packaged medical devices.

Both tray sealers and pouch sealers play critical roles in ensuring the safety, sterility, and functionality of the products. Tray sealers offer secure protection and organization, while pouch sealers provide flexible, sterile packaging options.

With the advancement of automation and technology, manufacturers can leverage these sealing solutions to meet high-quality packaging standards, ultimately benefiting healthcare providers and patients alike.

The choice between the two depends on the specific needs of the medical devices being packaged.

Contact the CeraTek team to learn more and determine whether our solutions align with your needs. Our team of industry experts is excited to help find the right solution for everyone!

Sealing Tyvek Pouches: Five Essential Areas of Focus

Jul 14, 2023 | Blog, CeraTek

In the field of medical device packaging, ensuring the sterility and integrity of the packaged products is of utmost importance. Sealing Tyvek pouches with a constant heat pouch sealer is a critical step in achieving this objective. Tyvek, a nonwoven high-density polyethylene material, possesses superior tear strength and puncture resistance.

Pouch sealing is an area that packaging engineers must focus on to maintain the quality of the Tyvek pouches.

Here are five areas to optimize:

Equipment Selection

Selecting the right constant heat pouch sealer is crucial for achieving consistent and reliable seals. Engineers should carefully consider factors such as seal width, temperature control capabilities, and ease of use.

It is essential to choose the right sealer for sealing Tyvek pouches. This is because it will have the appropriate settings to deal with the unique properties of the material effectively. Additionally, the equipment should be made of high-quality materials to maintain sterilization.

Seal Temperature, Pressure, and Dwell Time

Achieving the optimal combination of seal temperature, pressure, and dwell time is vital for creating a strong and hermetic seal. Engineers must determine the appropriate seal temperature based on the melting point of Tyvek. Conducting temperature mapping studies helps identify any hot or cold spots on the sealing surface, enabling adjustments to be made accordingly.

It is essential to set the right pressure and dwell time. This ensures sufficient heat and pressure are applied for a successful sterile barrier. At the same time, it prevents the pouch or the medical device from being damaged.

 Validation and Monitoring

Validation of the sealing process and regular monitoring of its performance are essential for maintaining seal quality and sterility. Engineers should develop a comprehensive validation protocol that includes process and performance qualification. Seal strength testing, microbial challenge testing, and visual inspection are critical elements to ensure that the seals meet the required criteria.

Monitoring sealing parameters, such as temperature and pressure, is essential. This allows us to detect any variations or deviations that could impact seal quality. Ongoing monitoring is necessary to ensure seal quality.

Process Control

Implementing robust process control measures is essential to ensure consistency and repeatability in the sealing process. Engineers should create standard operating procedures (SOPs).

These SOPs should clearly define the steps for sealing a Tyvek pouch with a constant heat sealer. These SOPs should include guidelines for equipment setup, temperature and pressure settings, and process documentation. Regular training of operators is essential to maintain process control and reduce human error. They must be taught the correct use of the equipment and must follow standard operating procedures (SOPs).

Regulatory Compliance

Compliance with strict regulatory requirements is vital in the medical device packaging industry. Packaging engineers must be knowledgeable about regulations and guidelines.

Examples include those set by the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO), such as ISO 11607 – Sterile Device Package Testing. Adhering to these regulations involves implementing appropriate design controls, documenting processes, and conducting validation activities. It is important for engineers to stay informed of the latest regulations. This ensures that packaging practices meet current standards.

Ultimately, packaging engineers can achieve reliable and consistent seals by carefully selecting the right equipment, optimizing seal temperature, pressure, and dwell time.

Validating and monitoring the process, implementing process control measures, and complying with regulatory requirements are necessary. Paying attention to critical areas is important for the integrity and success of medical device packaging. This ensures the safety and efficacy of sealed products, giving users confidence in Tyvek sterilization pouches.

The[PACK]out Conference

May 1, 2023 | Blog, CeraTek

Lynne Barton and Meghan Supple from CeraTek will be attending the[PACK]out Conference from The LINE Austin May 9 – 11, 2023 in Austin, TX.

Lynne will be partnering with Millstone Medical to present on the Tenured Track about inputs, process, and outputs. She will join other industry leaders in sharing best practices and some of our own research recently conducted to greatly improve the repeatability of our seal integrity.

Come join us for the presentation in May at the LINE in Austin.

Click here for registration information for the[PACK]out.

Why is Seal Strength so Important in Medical Device Packaging?

Dec 15, 2022 | Blog, CeraTek

Why is Seal Strength so Important in Medical Device Packaging?

In the realm of medical device packaging, an often-underestimated factor emerges for preserving product efficacy and patient well-being: seal strength.

Behind the scenes of sterile barriers and materials lies a critical element that wields influence far beyond its seemingly modest role.

Dive into the multifaceted significance of seal strength in medical device packaging and explores its implications for safeguarding the integrity of medical products.

What are the key attributes that makeup Seal Strength: Let’s Dive In!

• Tensile Strength: Tensile strength refers to the force required to pull apart the sealed components in opposite directions. It measures the integrity of the seal under stress, indicating how well the seal can resist forces that might occur during transportation, handling, or accidental impacts.
• Peel Strength: Peel strength measures the force required to peel back the sealed layers in a direction parallel to the seal interface. This attribute is particularly important for packages that are opened by peeling, such as pouches with easy-tear features. Adequate peel strength ensures that the package can be opened without compromising the integrity of the seal.
• Burst Strength: Burst strength assesses the pressure required to rupture the seal, simulating conditions like pressure changes during air travel or other environmental stressors. It ensures that the seal remains intact even under increased pressure differentials.
• Shear Strength: Shear strength evaluates the force needed to slide one sealed layer over another. This attribute is essential for packages that might experience sliding forces during transportation or handling. A strong shear strength prevents the layers from separating unintentionally.
• Environmental Resistance: The seal’s ability to resist degradation when exposed to external factors like moisture, temperature fluctuations, light, and chemicals is crucial. It ensures that the seal maintains its strength over the device’s intended shelf life.
• Consistency and Reproducibility: Seal strength should exhibit consistent and reproducible results across different batches of packaging. Manufacturers need to ensure that the seal strength remains within a specified range to guarantee uniform product quality.
• Material Compatibility: The materials used for the packaging and the sealing layer should be compatible to achieve optimal seal strength. Mismatched materials might lead to weak seals that can easily break or fail.
• Sealing Process Control: The method used to create the seal, such as heat sealing, ultrasonic sealing, or adhesive sealing, plays a crucial role in determining the seal’s strength. Manufacturers need to have precise control over the sealing process parameters to achieve consistent results.
• Regulatory Compliance: Regulatory standards often define acceptable seal strength criteria. Meeting these criteria is essential to ensure that the packaging complies with industry regulations and can withstand the challenges of the healthcare supply chain.

Three Reasons Seal Strength is of Utmost Importance in Ensuring Patient Safety

1. Contamination Prevention: The primary purpose of medical device packaging is to maintain the sterility of the enclosed products. A strong seal ensures that the package remains impervious to external contaminants, such as microorganisms and particulate matter. Inadequate seal strength can lead to breaches in the packaging, potentially allowing harmful agents to enter and compromise the sterility of the medical devices. This can result in serious infections and health risks for patients.
2. Product Integrity and Performance: Medical devices often contain sensitive components or materials that can be negatively affected by environmental factors such as moisture, oxygen, and light. A robust seal acts as a barrier, protecting the contents from these elements that could compromise the device’s functionality or structural integrity. A compromised seal might lead to damage, degradation, or alteration of the device, rendering it ineffective or unsafe for use.
3. User Confidence: Healthcare professionals and patients place their trust in medical devices and the manufacturers behind them. A reliable seal reinforces this trust by signaling that the product inside has been meticulously protected and remains uncontaminated. User confidence is essential for the effective adoption and usage of medical devices, and a strong seal contributes significantly to this assurance.

The complex nature of medical device packaging demands a deep understanding of materials, manufacturing processes, and quality assurance protocols.

A compromised seal could lead to devastating consequences. Thus, achieving optimal seal strength is not just a technical requirement but also a moral, ethical, and legal obligation.

We recognize the weight of this responsibility and are committed to providing solutions that ensure the highest standard of seal strength. Our expertise in this field stems from years of dedicated research, technological innovation, and collaboration with industry experts.

Our team is driven by a shared mission to advance the reliability of medical device packaging, constantly pushing the boundaries of what’s achievable. Contact us to learn more.

Safeguarding Lives: The Crucial Role of Sterile Packaging in the Medical Field

Aug 15, 2022 | Blog, CeraTek

In the intricate realm of modern medicine, one of the most critical yet often overlooked elements is sterile packaging. While the remarkable advancements in medical technology and treatments grab headlines, the importance of maintaining sterility through proper packaging cannot be understated.

Sterile packaging is not just about aesthetics; it plays a pivotal role in preventing infections, complications, and even fatalities.

Let’s explore the importance of sterile packaging within the medical realm and its role in preserving and enhancing human lives.

Why is Sterile Packaging Important?

Sterile medical packaging involves creating an environment free from microorganisms, ensuring that medical equipment, instruments, and supplies remain uncontaminated from manufacturing to their final use. This meticulous process involves using specially designed materials and techniques that inhibit the growth of bacteria, viruses, and fungi.

The ultimate goal is to provide healthcare professionals with tools and products that are entirely free from potentially harmful pathogens, reducing the risk of infections and complications in patients.

Preventing Infections

In healthcare settings, where patients are already vulnerable due to illness or injury, infections can be particularly devastating. Sterile packaging acts as a barrier, shielding medical devices and instruments from contaminants that could otherwise compromise patient health.

Surgical site infections, bloodstream infections, and other healthcare-associated infections can lead to

• Prolonged hospital stays
• Increased medical costs
• Mortality

By utilizing sterile packaging, medical professionals can significantly reduce the incidence of these infections, ultimately saving lives and improving patient outcomes.

Enhancing Surgical Procedures

Surgical interventions are intricate procedures where precision and sterility are of primary concern.

Surgeons rely on a wide array of tools and equipment to perform procedures that range from routine to complex. Sterile packaging ensures that these instruments are devoid of any harmful microorganisms, reducing the risk of post-operative infections.

A meticulously packed sterile instrument tray contributes to a seamless surgical process, allowing surgeons to concentrate on the procedure itself rather than worrying about contamination issues.

Protecting Implantable Devices

Implantable medical devices, such as pacemakers, joint replacements, and stents, have revolutionized the treatment of numerous conditions. However, if these devices are not packaged and handled with stringent sterilization practices, they can introduce infections or complications when implanted within the body.

Proper sterile barriers of these devices ensure that they remain free of pathogens, minimizing the potential for adverse reactions and contributing to the longevity of the implants.

Emergency Preparedness

In times of crisis, healthcare systems are strained to their limits. Having access to pre-packaged sterile medical supplies becomes even more critical in these scenarios.

Sterile packaging allows for quick and efficient distribution of medical products to emergency response teams and healthcare facilities. These supplies can be readily deployed to treat patients in dire circumstances, preventing secondary infections and saving lives amidst challenging conditions.

Ultimately, sterile packaging may not be as glamorous as cutting-edge medical technologies, but its impact on patient outcomes cannot be overstated. By preventing infections, enhancing surgical procedures, protecting implantable devices, and aiding emergency preparedness, sterile packaging plays a vital role in saving lives within the medical field.

As we celebrate the remarkable strides in medical science, let’s also acknowledge the significance of the seemingly simple act of maintaining sterility.  Please contact us to learn more about how to safeguard lives and promote the well-being of patients around the world.