Blogs

Tyvek is a highly durable and lightweight material that is commonly used in the medical industry for the packaging and sterilization of medical devices and equipment. It is a non-woven material made from high-density polyethylene fibers that are bonded together using heat and pressure. Medical device manufacturers and packaging professionals prefer Tyvek packaging because it is a sterile barrier that protects against bacteria and other contaminants. Tyvek is also breathable, allowing for sterilization methods such as ethylene oxide and gamma irradiation to be used effectively.

Tyvek packaging is used in a variety of medical applications, including surgical gowns, drapes, and covers, as well as in medical device packaging such as catheters, implants, and instruments. Its use in the medical industry is regulated by government agencies such as the FDA to ensure that it meets the necessary standards for safety, sterility and efficacy.

What are the Challenges Associated with Tyvek Package Testing?

Leak testing of Tyvek packages is a critical step in ensuring the integrity of the package and the safety of its contents. However, there are several challenges associated with leak testing Tyvek packages, including:

• Sensitivity of the test method: The sensitivity of the leak testing method can impact the ability to detect leaks in Tyvek packages. For example, some testing methods may not be able to detect very small leaks or may be impacted by the size or shape of the package.
• Environmental conditions: Environmental factors, such as temperature, humidity, and pressure, can impact the results of the leak test. For example, changes in temperature can cause the package to expand or contract, which can impact the tightness of the seal and the results of the test.
• Interference with product properties: Some leak testing methods may use test gases or liquids that can interact with the product inside the package. For example, the test gas may cause the product to degrade or impact its efficacy, which can affect the overall performance of the package.

In summary, leak testing of Tyvek packages requires careful consideration of the test method, the packaging process, and the environmental conditions to ensure accurate and reliable results.

Testing Tyvek Packages Using Airborne Ultrasound Technology

With today’s sensory technology advancements, Tyvek packages can be tested using Airborne Ultrasound technology. Airborne Ultrasound technology is a seal quality testing method that uses airborne ultrasound to evaluate seals for flaws and defects non-destructively. It is an ASTM Test Method F3004 for testing the seal quality and a recognized FDA standard for seal quality inspection. These tests are mostly carried out to improve seal quality inspection of pouches, flexible packaging, and tray seals. Tyvek, paper, foil, film, aluminum, plastic, and poly are just a few of the packaging materials that may be used with Airborne Ultrasound technology to enable thorough seal quality evaluations.

In this method, sound waves are reflected as ultrasonic waves are transmitted through the packaging seal. If there is a leak or flaw, the signal intensity is decreased or lost. To find the leak, these differences are closely monitored. Most leak test techniques encounter the problem of being unable to identify non-leaking defects. By using Airborne Ultrasound technology, users may recognize a variety of seal faults, including visible and invisible, leaking and non-leaking, process-related and random. Airborne ultrasound can be applied in the laboratory for offline in-depth seal quality analysis as well as for 100% online seal quality inspection on the production line.

Benefits of Airborne Ultrasound Technology

• Non-destructive, non-subjective, no sample preparation.
• Deterministic inspection method producing quantitative results.
• Can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable and reliable results.
• Eliminates subjective manual vision inspection methods.
• Characterizes overall quality and uniformity of the seal.
• Economical cost-effective solution for seal integrity testing the final pouch seal.

The method used for leak testing Tyvek packages will depend on the specific requirements of the medical device or equipment being packaged and the regulations set forth by regulatory agencies such as the FDA. It is important to use a validated and appropriate method for leak testing to ensure the safety and effectiveness of the packaged medical devices or equipment. Airborne Ultrasound is one such technique.

Container Closure Integrity (CCI) refers to whether a container keeps the sterile barrier intact. Environmental pollutants can quickly turn a life-saving therapy into a microbial soup if there is a leak or breach of the sterile barrier. The CCIT of blister packages is a critical process in ensuring the quality and safety of pharmaceutical products. Blister packages are commonly used to package solid-dose medications such as tablet and capsules.

The CCI testing of blister packages is performed to ensure that the package is properly sealed and that there are no leaks or defects that could compromise the quality of the medication inside. This testing is important because if the package is not properly sealed, moisture and oxygen can enter, potentially degrading the medication and reducing its effectiveness.

Overview of OptiPac Technology

OptiPac One-Touch Tool-less Leak Detection Technology is a non-destructive method for testing the integrity of blister packaging that is designed to detect any leaks or defects in the package's seal. OptiPac uses volumetric imaging technology to measure the blister cavities under vacuum and identify leaks. The OptiPac applies controlled inputs and measurable outputs without the inconvenience and reliability concerns of the dye ingress approach. It is designed with One-Touch Technology to accomplish a quick test cycle needing no changeover or tools for various blister formats. Unlike other non-destructive blister package inspection systems that demand complicated parameter modifications, OptiPac requires no tooling replacement with new blister package forms.

The test begins by placing the sample on the testing area for vacuum-based measurement. Vacuum is pulled to a definite vacuum after pushing the start button. Under vacuum, blisters expand and push air out of the blister through any leaks that may be present. If there is a leak in the blister, air leaks into the chamber and collapses the blister package. The defective blister cavities are identified using a volumetric measurement reading during the dynamic vacuum test cycle. Along with the quantitative measurement related to each package test, a clear pass/fail result is displayed.

Functions Offered by OptiPac's Insightful Technology

• Auto configuration for easy recipe setup and validation of new blister formats.
• Auto orientation of blister packs (test blister packs in any position –no specific orientation).
• Auto calibration is an integrated one-touch function.
• Advanced batch reporting with audit trail including image of blister pack and defect results.

OptiPac Benefits

• Non-destructive technology - Pass/Fail results backed by quantitative test data.
• Completely tool-less.
• No changeover to test different blister formats.
• Identifies defective cavity.
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats.

In addition to selecting the appropriate method for leak testing, other factors to consider when performing blister package leak testing include the type of material used for the package, the seal strength of the package, the packaging process, and the potential for environmental factors to affect the package's integrity. By carefully considering these factors and implementing an effective leak testing (pharmaceutical package testing) process, pharmaceutical companies can ensure that their products are of the highest quality and meet regulatory requirements.

Automated Container Closure Integrity Testing (CCIT) is a process used to evaluate the integrity of containers for parenteral products, such as vials or pre-filled syringes, to ensure that they are free of defects or leaks. The goal of CCI testing is to ensure that the contents of the container remain sterile and protected from contamination.

There are several advantages to using automated CCI testing, including:

• Speed and Efficiency: Automated CCI testing is much faster and more efficient than manual operator testing, which can save time and resources for manufacturers.
• Accuracy: Automated CCI testing is less prone to human error, which can result in more accurate results and increased confidence in the integrity of the container.
• Reproducibility: Automated CCI testing is designed to be repeatable, allowing manufacturers to consistently and accurately monitor the integrity of containers.

Parenteral Products and its Advantages

Parenteral products are medical products that are administered directly into a patient's bloodstream, bypassing the digestive system. This means that the product is delivered into the body through a route other than the orally, such as intravenously, intramuscularly, subcutaneously, or through other routes. Examples of parenteral products include injectable drugs, intravenous solutions, intravenous nutrition products, blood transfusions, and others. These products are subject to strict quality control and regulatory standards to ensure their safety, efficacy, and sterility, and to maintain the integrity of their packaging to prevent contamination. The specific form of the parenteral product (e.g. solution, suspension, etc.) depends on the product and patient needs.

Advantages of Parenteral Products

Here are some advantages of parenteral products:

• Rapid onset of action: Parenteral products are delivered directly into the bloodstream, which allows for a faster onset of action compared to oral administration. This can be especially important in emergency or critical care situations.
• Measures and verifies container closure system integrity
• More effective for some conditions: Some drugs and therapies are more effective when delivered parenterally because they are absorbed more quickly or may not be well absorbed orally.
• Alternative for patients unable to take oral medications: Parenteral products provide an alternative for patients who are unable to take oral medications, such as patients with gastrointestinal issues or patients who are unconscious.

CCI Testing of Parenteral Products

CCI Testing is performed on parenteral products using a variety of methods, including vacuum decay leak testing, high-voltage leak detection, and others. The specific method used will depend on the type of product, the packaging material, and the desired level of sensitivity. The goal of CCI testing is to provide confidence in the integrity of the packaging and prevent any incidents of contamination or product failure.

The VeriPac LPX Series is a range of completely automated package quality inspection systems for container closure integrity inline testing. The VeriPac LPX has a dynamic robotic design that is customized to your production needs. To fulfil the demands of a production line, the LPX Series offers modular, scalable solutions. This adaptable platform offers a range of package forms that may be reliably automated. Flexible packaging, rigid containers, and parenteral pharmaceuticals are only a few examples of the applications for LPX automation.

The packages will be picked up and placed by a quick robotic gripper arm into the VeriPac LPX test chambers, where a quick vacuum-based test will be performed. Along with the quantitative test result data, a clear PASS/FAIL result is shown. In order to maintain continuous flow and seamless downstream processing, the packages will then be returned to the product line. Rejects are automatically taken off the production line.

Benefits of VeriPac LPX

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard.
• Highly accurate test results - low false positives and false negatives.
• Non-destructive, non-subjective, no sample preparation.
• USP <1207> complaint.

CCI testing is used to evaluate the sealing of the product container and detect any leaks, breaches, or defects in the packaging. This is important because parenteral products are sensitive to environmental factors such as temperature and pressure changes, and any breaches in the packaging could result in contamination or degradation of the product.

Overall, automated CCI testing is an important tool for ensuring the safety and quality of parenteral products, and is increasingly being used by manufacturers to ensure that their products meet regulatory requirements and industry standards.