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.
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.
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
- 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.
- 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.
- 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.
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.
Mar 9, 2022 | Medical Pouch Sealer
Your Step-by-Step Guide to Applying a Vacuum or a Vacuum and Gas Flush to a Pouch
Many manufacturers have questions about applying a vacuum only or a vacuum and gas flush to a pouch. In this blog post, we’ll explain:
- The most common applications for applying a vacuum or a vacuum and gas flush to a pouch
- How pouch materials impact which application is optimal and the best methods for working with common pouch material combinations
- The process for using a nozzle to apply a vacuum or a vacuum and gas flush to a pouch
- The process for using a chamber to apply a vacuum or a vacuum and gas flush to a pouch
Understanding these fundamental concepts and best practices will help you determine which application is optimal for your use case.
How to apply a vacuum or a vacuum and gas flush to a pouch
A vacuum or a vacuum and gas flush can be applied to a pouch in one of two ways—either by using a nozzle sealer or by placing the pouch in a chamber sealer. The optimal method is dependent on the type of pouch materials being used, whether vacuum only or vacuum and gas flush is required, and other factors.
A nozzle sealer is most commonly used for:
- Volume reduction. The goal of volume reduction is to remove enough air from the pouch to prevent it from popping during high altitude shipments or so that it can fit into a box or secondary container. Because volume reduction applications are considered a “gross” vacuum process, either time-based or level-based programs can be used; however, a time-based mode is the most popular. Product sensitivity can play a role in how much volume should be drawn out of the pouch.
- Product immobilization. In certain cases, it is critical to remove air from the pouch so that the product being packaged is immobilized. Product immobilization applications are considered a “gross” vacuum process so either time-based or level-based programs can be used; however, since the final internal volume in the pouch is a function for immobilizing the product, operating in level mode provides greater reassurance that the appropriate internal pressure has been achieved to restrain the product in the pouch. Product sensitivity can play a role in how much volume should be drawn out of the pouch.
- Reducing O2 or relative humidity (RH). Multiple vacuum/flush cycles can be programmed to progressively reduce the O2 or RH in the pouch. While modifying the atmosphere in the pouch can be programmed as a time-based function, vacuum and flush levels are critical in adequately and repeatedly reducing oxygen or relative humidity. That is why most applications requiring reduced O2 or RH operate in level mode. The flexibility of the pouch materials and their ability to conform around the geometry of the nozzle can affect the achievable goal, even with multiple cycles.
A chamber sealer is most commonly used for:
- Achieving ultra-low residual O2 Vacuum and gas flush applications requiring an extremely low residual oxygen level (below 1%) require a chamber sealer. A nozzle sealer cannot be used for these applications because of the “leak points” around the nozzle while it is processing the pouch. For ultra-low residual O2 level applications, the entire chamber atmosphere is modified and level setpoints as low as 1mbar can be programmed. A dwell time at each step can be programmed to maintain the level for the specified amount of time and allow the product to acclimate.
- Sealed header pouches. Sealed header pouches that need to be vacuumed and/or flushed must use a chamber sealer because it is physically impossible to insert a nozzle into a hermetically sealed and terminally sterilized pouch. In these cases, the atmosphere inside the pouch is modified by vacuuming and/or flushing through the Tyvek window on the pouch. For this type of application, a program that has the flexibility to allow multiple steps in either direction (vac-vac-vac-flush-vac-flush-flush, for example) with programmable dwell times at each step will provide the control required to vacuum the pouch without bursting it or to flush the pouch without crushing the product or pinching off the header. The atmosphere inside the chamber can change significantly faster than the interior of the pouch because the header acts as a filter, hampering the flow of air and/or gas into and out of the pouch. A dwell time at each vacuum or flush step can provide the necessary time for the pouch to acclimate to the chamber atmosphere before the next process step begins.
Pouch materials impact whether a nozzle or chamber should be used for applying a vacuum or a vacuum and gas flush
The pouches used for vacuum (no gas flush) and vacuum and gas flush applications are typically made from laminated or mono-layer flexible materials including—but not limited to—Tyvek, coated foil, and film. The specific materials used impact whether a nozzle or chamber is optimal, and these are the most common pouch material combinations and the method that works best for applying a vacuum and/or gas flush to each one:
- Foil/Foil: Nozzle or chamber
- Film/Foil: Nozzle or chamber
- Film/Film: Nozzle or chamber
- Foil/Tyvek Header: Chamber
- Film/Tyvek Header: Chamber
- Film/Tyvek: Nozzle
Other factors to consider before deciding to use a nozzle to apply a vacuum or a vacuum and gas flush to a pouch
A number of different factors should be considered before deciding to use a nozzle sealer to apply a vacuum or a vacuum and gas flush to a pouch. Here is a sampling of the top concerns:
- Headspace. Since using a nozzle involves employing a clamp between the guarding and the sealing die, the pouch must have sufficient “free” material (i.e., headspace) for loading into the sealer.
- Nozzle length. In order to be able to load the pouch over the nozzle, the nozzle must extend out of the sealer at least ½” resulting in nozzle penetration into the pouch of typically at least 1½” for constant heat sealers.
- Product sensitivities. If the nozzle must not come into contact with the product, the pouch length must be sized appropriately to allow the product to remain safely distant from the nozzle.
Other factors to consider before deciding to use a chamber to apply a vacuum or a vacuum and gas flush to a pouch
Before deciding to use a chamber to apply a vacuum or a vacuum and gas flush to a pouch, it is important to consider factors such as:
- Immobilizing the pouch. It is critical to immobilize the pouch during the vacuum and flush process. The air inside the chamber can become turbulent, and if the pouch shifts out of alignment with the seal bar, the pouch will not be sealed correctly.
- Cycle time. The cycle time when using a chamber sealer will always be longer than when using a nozzle sealer because of the volume of air that is being modified. A nozzle sealer is modifying only the interior of the pouch. By contrast, a chamber sealer is modifying the volume of the entire chamber and the pouch. Additionally, processing a header pouch for a low residual oxygen level application requires the most time and may require multiple vacuum/flush steps with dwell times at each step.
- Window for visibility. Using a chamber sealer that has a window for viewing the pouch as it is being processed can have enormous benefits. A window allows visibility into the process and enables the operator to monitor how the pouch is behaving during the vacuum, flush, sealing and repressurizing process.
The process for using a nozzle sealer to apply a vacuum or a vacuum and gas flush to a pouch
Using a nozzle sealer to apply a vacuum or a vacuum and gas flush to a pouch is a relatively straightforward process involving eight distinct steps:
- Bring the nozzle into the load position
The nozzle used to apply a vacuum or a vacuum and gas flush to a pouch is like a snorkel or “straw.” In the first step of this process, the operator presses a foot switch that brings the nozzle into the load position.
- Load the pouch over the nozzle and slide it into the seal area
With the nozzle in the load position, the operator places the pouch over the nozzle and slides it into the seal area.
- Close off the pouch around the nozzle
Next, the operator presses the foot switch a second time, bringing a soft-faced clamp down to close off the pouch around the nozzle.
- Initiate the vacuum process, followed by gas flush, if needed
Once the pouch is closed off around the nozzle, the vacuum process can begin. If a gas flush process is programmed, the gas will flush the pouch upon completion of the first vacuum process. Additional vacuum and gas flush cycles can be programmed depending on the application requirements.
- Apply final cycle
The cycle can be programmed to end after a flush step, leaving a “pillow effect” in the pouch, or it can be programmed to end after a vacuum step, drawing the pouch down around the product.
- Retract nozzle while clamp is still engaged
Once the vacuum/flush cycle has fully completed, the nozzle retracts from the pouch while the clamp is still engaged.
- Actuate seal bar and seal the pouch
After the nozzle is clear of the seal area, the seal bar actuates and seals the pouch.
- Releasing the pouch from the sealer
In the last step of the process, the seal bar and the clamp open, releasing the pouch from the sealer.
The process for using a chamber sealer to apply a vacuum or a vacuum and gas flush to a pouch
Using a chamber sealer to apply a vacuum or a vacuum and gas flush to a pouch is a relatively straightforward process involving eight distinct steps:
- Load the pouch onto a platform in the chamber
When a chamber sealer is used to apply a vacuum or a vacuum and gas flush to a pouch, the process begins when the operator loads the pouch onto a platform inside the chamber sealer.
- Close the lid and apply the vacuum
Next, the operator closes the lid of the chamber sealer and initiates application of the vacuum. The entire volume inside the chamber is vacuumed until the programmed level is reached.
- Initiate the gas flush
The gas flush process begins after the initial vacuum step(s) are completed and flushes the entire chamber to the programmed setpoint.
- Apply additional vacuum and gas flush cycles as needed
Additional vacuum and gas flush steps can be programmed to achieve even lower residual oxygen levels.
- Shuttle the pouch into the seal area and apply the seal
Once the vacuum/gas flush process is completed, the pouch is shuttled into the seal area and the seal bars close, sealing the pouch.
- Shuttle the pouch back to the load position
After the seal dwell timer has elapsed, the pouch is shuttled back out into the load position.
- Repressurize the chamber and open the lid
Next, the chamber repressurizes back to atmosphere and the lid opens.
- Remove the pouch from the chamber
Finally, the operator removes the pouch from the chamber.
This blog post covered several of the primary issues you need to consider when determining how best to apply a vacuum or a vacuum and gas flush to pouch. For more information and to discuss the details of your particular application, please contact us.
