ASTM D4169 and ISO 11607 are the guidepost test standards for medical packaging. These tests provide a reliable indicator that medical devices remain in a sterile environment during the distribution stages. To avoid the risk of a costly product recall, the sterile barrier system must protect the packaged product and maintain the sterility of the product from the moment it leaves your manufacturing facility until the end-user opens it.

Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real-time and accelerated aging. When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of expiration date or shelf life is based on the use of a conservative estimate of the aging factor (for example, Q10) and is tentative until the results of real-time aging studies are completed on the sterile barrier system.

To rapidly determine the effects of time on the integrity of the sterile barrier system and the physical properties of their component packaging materials.

The loss of sterile barrier system integrity may occur as a result of the physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling. ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain the integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real-time aging studies are available.”

Many materials from which containers and packages are made, especially cellulose materials, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied.

Therefore, the package should be placed and kept in a specified atmosphere for a length of time such that subsequent measurements of physical properties will be meaningful and reproducible.

Infinity Laboratories is fully equipped with Environmental Chambers to accommodate your thermal testing requirements including: high and low temperature testing, relative humidity testing and other environmental testing needs.

A drop impact test is the only reliable and accurate method for assessing whether or not the selected packaging is appropriate for use. The good news is Infinity Laboratories can provide the necessary ISTA drop test procedures needed to rate any type of packaging.

The package testing services that are offered by Infinity Laboratories simulate the common types of events that are most often associated with the distribution environment, including manual handling. These services can accurately validate packages for distribution as well as certify them as being compliant with current, published ISO Standards, ASTM Standards and other compliance requirements for a variety of industries. Infinity Laboratories understands that it is the responsibility of the manufacturer to accurately evaluate each package’s capability to protect the equipment or product inside the package throughout the handling, distribution, and storage process.

At Infinity Laboratories, we conduct repeatable drop impact tests on using flat, corner, and edge drops. Each of these drop tests is conducted without rotation to the package which allows it to land in the same manner in which it was released. By using advanced equipment, we are able to accurately measure the various acceleration levels that the package experiences. Our technology thus allows our engineers to determine whether or not product cushioning will be required. This information can then be used to determine what type of cushioning will best protect the package and its contents should mishaps occur during the distribution chain.

Because of the skill and care we take with our drop test procedures, we are able to provide our customers with reliable evaluations, conducted in within a laboratory environment, that can be invaluable in our customer’s assessments of what type of packaging and cushioning they need. Infinity Laboratories uses accredited procedures such as the ISTA drop test procedure.

If your company is in need of reliable, accurate, and accredited drop testing for packages, consider consulting with Infinity Laboratories. We offer our customers incredible value as well as honest evaluations. At Infinity Laboratories we can evaluate virtually any type of packaging in our certified testing laboratories. This allows us to deliver the best consultations. We can even assist our customers in determining which drop test procedure is best suited to their individual needs.

Simply use our online form or give Infinity Laboratories a call today to speak with one of our highly skilled and knowledgeable representatives. Contacting Infinity Laboratories for your drop testing needs is the first step in protecting the valuable contents of your packages and helping to reduce disappointment and frustration in your customers. Why take a chance on damaged goods? Contact Infinity Laboratories today and let us assist you in your impact drop testing needs.

Make Sure Your Containers Meet the Highest Standards

The container must be sturdy enough to shield its contents from damage. Consumers are entrusting the safe delivery of their goods to your industry. It is our hope that you, in turn, entrust us for performing and evaluating the compressive resistance of your containers whether they be simple corrugated fiberboard boxes, wooden crates or steel drums. Our ASTM static compression load test evaluates the container’s ability to resist compressive force from different angles and with multiple variations taken into consideration. We send you a full report with our findings and all the numbers and figures included. Even the sturdiest containers have a breaking point and knowing what that limit helps you make cost-effective solutions when transporting goods without risking damage.

Give us a Call and Get Started Today

Please contact us today; we adopt a business model that meets the most rigorous professional standards. We are confident that our service is among the top in its industry. We only use state-of-the-art compression testers and will have a full report sent to you within days of a test evaluation with pinpoint and accurate results. Our report has all the relevant details, numbers and figures organized in an easy-to-read format, and you will know the specific threshold of your containers. We will also provide an in-depth assessment of what and where the upgrades need to be made if any are recommended. Get started with us today and learn where your containers stand in the strength and durability compartment.

Significance

The most important function of reduced pressure testing is, in the end, saving you money. There are two major ways that the tests will help to save you money, which we’ll discuss here. The first is ensuring that the product arrives safely to your customer’s house; if it’s damaged mid-flight by the low-pressure environment, then you could find yourself forced to replace goods on a regular basis, and that’s extraordinarily bad for your bottom line. The second form of saving your money is a little more tricky, and you have to be very careful when looking at the results of the test. Some items aren’t destroyed mid-flight, but they are damaged and will wear out much sooner than intended. In cases like these, customers may wind up calling in their warranties on a regular basis; as above, this could quickly become a very expensive problem. Proper testing (both in low-pressure environments and afterward, through your own quality control) will help to stop these problems from happening at all. If you’re dealing with delicate items, then reduced pressure testing is the best way to check for problems and save a lot of money on replacements and repairs.

3) Warehousing environment
Last but not least, products and packaging experience vibration during storage occurs while they are stored on shelves and flooring due to vibrations given off by climate control systems, equipment and passing vehicles.

Our Methodology

Infinity Laboratories’ testing methodology covers a variety of packaging materials as well as vibration stressors. Tests such as the bounce test and ASTM D642 are designed to test the package’s durability and ability to protect its internal contents under specific conditions. Each test is designed to fully test the viability and performance of each container and its ability to protect its contents when subjected to vibrations. Infinity Laboratories’ testing methodology meets the requirements of the International Organization for Standardization standards ISO 8318 and ISO 2247.

Random Vibration Methods

During transit, any given package can experience a wide variety of shakes and bumps – everything from sudden drops in altitude to sharp turns on the road can slam a package around, which is why random vibration testing will subject each package to shocks and movement from different angles.

Random vibration testing is also significantly more realistic than some other types of testing; when tests done from the same angle are performed over and over, stress and pressure can build up in a way that would never happen in a real-life transportation situation. Tests also take into account actual data from shipping to further increase the realism of the tests and provide the most useful results. If a redesign of the packaging is needed, random vibration tests can help indicate exactly where improvements need to be made.

Maintaining Product Integrity

As a business, you want to ensure that your products reach your customers in A+ condition. Are you implementing random vibration testing that guarantees a high level of quality to the end-user? If not, you’re losing integrity and customer satisfaction for your brand name. With specific vibration methods completed in a random vibration testing lab, you can discover and fix weak points for the product during the wear and tear of the distribution process. Quality assurance departments, company engineers and corporate executives need to have random vibration testing done for success.

Learn More about Infinity Laboratories Environmental Testing and Packaging Services

Get a quote for your random vibration testing and packaging needs. Infinity Laboratories is providing testing and packaging services to the electronic, medical device, component manufactures, packaging and aerospace industries. We offer a wide spectrum of testing services in a vibration testing lab to ensure the product is in top-notch condition when it reaches the market.

This test method is intended to determine the ability of packaging to protect contents from such impacts and to evaluate if there is sufficient clearance or support or both between the package wall and its contents.

Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems. Visual seal defects often will be the first indication of the heat sealing process variation. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing.

At Infinity Laboratories, our engineers will thoroughly inspect your packaged product for any signs of defects or failures, carefully identify and record all the data and present it to you in the final visual inspection report.

There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leakage, components that exhibit any indication of leakage are normally rejected. Since leaks may change in size with different ambient conditions, comparisons between test stations are not conclusive. Therefore this method is usually employed as a go, no-go test. The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material.

While detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) the package is inflated underwater to a predetermined pressure. The package is then observed for a steady stream of air bubbles indicating a failure area.

Typical parameters may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article.

These test methods do not necessarily provide correlation with actual package seal strength as typically measured using Test Method ASTM F 88 (or equivalent).