Medical Device Testing
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.
ACCELERATED AGING (ASTM F1980-16)
Real-time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real-time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means. To ensure that accelerated aging studies do truly represent real-time effects, real-time aging studies must be conducted in parallel to accelerated studies. Real-time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
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.”
ATMOSPHERIC CONDITIONING (ASTM D4332-14)
To provide special atmospheric conditioning that may be used to simulate field conditions that package may encounter during its life or testing.
Environmental Conditioning Testing includes Temperature Test and Humidity Testing subjecting the packaging to extremes it may be exposed to during distribution and storage and under which it has to maintain its sterile integrity. Depending on the product’s distribution and end-use destinations Thermal Testing may also include exposure to various chemical and biological threats.
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.
MANUAL HANDLING (ASTM D5276-17)
This test method is intended for use in evaluating the capability of a container to withstand the sudden shock resulting from a free fall or to evaluate the capability of a container.
For manufacturers and vendors who ship products, drop testing is a crucial element for the packaging that they select. Without having reliable data concerning a package’s ability to maintain its integrity and strength, vendors and manufacturers are at risk of delivering damaged goods or equipment to their customers.
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.
COMPRESSION (ASTM 642-15)
Why Compression Testing Matters
Compression testing is vital for measuring the compressive strength of packages and containers. As an industry, you want to supply your consumers with the best end-product. Whether the containers are manufactured for customer use or for delivering products and other goods, the package must be durable and be able to hold up and protect its contents from compression. To ensure that your containers are in accordance with regulation and meet the highest quality standards, compression testing is necessary for determining how individual freights are able to hold up when pressure is exerted at different points of the container. Knowing the tolerance level your containers can withstand before they yield or break is integral for ensuring the safety of their contents.
Our Compression Testing Method Outperforms the Competitors
Our compression load test utilizes the most stringent standards to ensure accurate results. All variables are taken into consideration so that the data is reliable. We use the ASTM D642 with both a fixed-head and swivel platen compressor to perform corner-to-corner and edge-to-edge orientations on all specimens under testing. This determines whether the specimen will fail at both its strongest and weakest points. The procedure measures the container’s ability to resist external compressive loads applied directly to its face, in the corners or diagonally in the opposite edges. Testing can be applied to containers with or without contents. Knowing the yield stress limit of containers helps determine how containers can be stacked or positioned and secured when preparing them for transportation.
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.
LOW PRESSURE TESTING (ASTM 6653-13)
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 are 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.
Low-pressure testing is a technique where the environment of a package in flight is reproduced at ground-level, allowing for a far more affordable method of testing the impact of lower pressures on any given package. In most cases, this only needs to be done once for any given item (including the packaging itself) to be sure that it will continue to function as intended. Every package altitude test provides valuable information about how a product will endure the more extreme environment of air transportation, and it can let you know whether or not you need to arrange for an alternate form of transportation.
Get Expert Help
Infinity Laboratories works to test your packages in a variety of environments, depending on the types of situations they might face -including low-pressure tests. If you ship products through the air, then this is testing you need to have done. Once you have the results, you can make adjustments to your shipping method or your containers to compensate. With the right testing, you can drastically reduce your chances of having products damaged. Request for a quote for more information about testing schedules and making sure your packages will always be kept safe!
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.
LOOSE LOAD VIBRATION (ASTM D999-15)
Loose Load Vibration Methods
When it comes to loose load vibration and fixed displacement vibration testing, there are three areas of focus that Infinity Laboratories uses to assess a package’s ability to protect products. These include:
1) Transit Environment
Different transportation solutions expose packages to different vibration stressors. These stresses are simulated in the laboratory and the results of our tests provide critical information to package manufacturers in order to assist them in creating superior packing solutions.
After transit, products and packaging are subjected to additional vibrations as they are moved around the storage facility using the equipment. Once again, Infinity Laboratories’ tests ferret out weaknesses in package design and the results are provided to manufacturers in order to create better packaging.
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.
In particular, exposure to loose load vibration can have a significant impact on the shipping container, its interior packaging components, and its contents. Infinity Laboratories’ tests allow researchers the ability to analyze the interaction of each of these components in order to determine the best way to minimize damage. Design modifications are based on the results of the test to achieve optimum performance in all aspects of the shipping and storage environments. Whenever possible, laboratory results are compared to real-world data in order to understand the common failures of packaging in the real world.
If your business is in need of a better way to ship products or need to test new package designs for effectiveness, request for a quote today!
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.
VEHICLE VIBRATION (ASTM 4728-17)
Get Optimal Quality Assurance for Your Products
With random vibration testing and other random vibration methods, businesses can attain high levels of quality assurance for their specific product needs. For example, those in the medical industry can have specific tests to ensure a sterile barrier system to protect the packaged product from the second it leaves the facility, through the distribution process and until it reaches the end-user. Those in the manufacturing industry of electronic components can have environmental testing done, such as thermal shock testing and salt fog testing, to ensure that metals and protective coverings are free from corrosion and resistant to extreme changes in temperature.
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.
CONCENTRATED IMPACT (ASTM D6344-17)
This test method is for testing complete filled transport packages for resistance against concentrated low-level impacts typical of those encountered in the distribution environment.
The Concentrated Impact test is intended to evaluate the ability of packaging to resist the force of concentrated impacts from outside sources, such as those encountered in various modes of transportation and handling. These impacts may be inflicted by adjacent freight jostling against the package in a carrier vehicle, by accidental bumps against other freight when loaded or unloaded from vehicles, by packages bumping against one another during sorting on conveyors or chutes, or any other circumstances.
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 INSPECTION (ASTM F1886-16)
This test method will visually detect channel defects and/or potential compromise to medical package integrity after the course of testing.
The ability to visually detect channel defects in package seals are highly dependent on the size of the channel, the degree of contrast from sealed and unsealed areas, the amount and type of adhesive between the two package layers, reflecting light angle, types of material used, the use of magnification, and the inspector’s level of training and experience. This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed. Seal attributes can be linked directly to a number of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity).
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.
DYE PENETRATION (ASTM F1929-15)
This test method will detect and locate a leak in package edge seals formed between a transparent film and a porous sheet material.
Harmful biological or particulate contaminants may enter the device through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material. This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.
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.
GROSS LEAK TESTING (ASTM F2096-11)
This test method covers the detection of gross leaks in medical packaging. It may be used for tray and pouch packages of medical devices.
The internal pressurization test method provides a practical way to examine packages for gross leaks, which may render the product non-sterile. What so called “Bubble” test method is extremely useful in a test laboratory environment where no common package material/size exists. Gross Leak “Bubble” test method may apply to very large or long packages, which do not fit into any other package integrity test method apparatus. This test method may be used as a means to evaluate package integrity. Package integrity is crucial to consumer safety since heat-sealed packages are designed to provide a contamination-free and sterile environment to the product.
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.
BURST TEST (ASTM F1140-13)
This test method will determine the ability of medical device packages to withstand pressure differentials that may occur during sterilization or transportation.
Burst Test method provides a rapid means of evaluating tendencies for medical device package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation. These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package’s life cycle. If correlations between pieces of test equipment are to be made, it is important that all parameters of the test method be exactly the same.
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).
TENSILE STRENGTH TEST (ASTM F88-15)
This test method measures the force required to separate a test strip of material containing the seal. It also identifies the mode of specimen failure.
Seal strength is a quantitative measure for use in process validation, process control, and capability. Seal strength is not only relevant to opening force and package integrity, but to measuring the packaging processes’ ability to produce consistent seals. Seal strength at some minimum level is a necessary package requirement, and at times it is desirable to limit the strength of the seal to facilitate opening.
The maximum seal force is important information, but for some applications, the average force to open the seal may be useful, and in those cases also should be reported. A portion of the force measured when testing materials may be a bending component and not seal strength alone. A number of fixtures and techniques have been devised to hold samples at various angles to the pull direction to control this bending force. Because the effect of each of these on test results is varied, consistent use of one technique (Technique A: Unsupported, Technique B: Supported 90 deg, or Technique C: Supported 180 deg) throughout a test series is recommended.
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