Evaluate Package Performance with Simulated Distribution Testing
Ensure the reliable and safe delivery of your packaged-products to the end user with our laboratory testing services. From primary packages to pallets of finished goods, we help you demonstrate your packaging system’s ability to withstand common transport hazards, such as drops, vibrations, high altitude, temperature changes, and more while remaining intact and protecting the integrity of your product. Our team of experienced packaging professionals will work with you to develop custom testing solutions so that you can feel confident in your product’s performance and the safety of your end user.
Partnering with our expert team empowers your program to:
- Develop new packaging configurations for domestic and international shipment.
- Identify potential failure points for your packaging system.
- Optimize and validate your production process and parameters for a variety of packaging components.
- Qualify passive and active thermal containers for cold chain shipment.
- Determine the effects of temperature changes on your components, packages, or products.
- Ensure your packaging system’s compliance with industry standards, such as ISO 11607.
- Evaluate the functionality of your product after exposure to physical hazards during transit or storage.
Package Testing
Pharmaceutical Packaging
Drug product packaging must be capable of withstanding the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity and protects the primary product – without such investments in design and testing, lifesaving therapies may not reach the patient in usable form.
Medical Device Packaging
Satisfy requirements by ensuring the integrity of sterile medical device packaging within ISO 11607 compliance. Medical Device package validation incorporates package stability testing, performance/dynamics testing, and strength and integrity testing following industry regulatory requirements.
Combination Product Packaging
Packaging is a crucial aspect to the safe and effective use of drug-device combination products. Given the varying approaches and expectations between regulators for medical devices and drug products, our team provides expert insight into how to thoroughly and appropriately assess your packaging to satisfy the applicable guidelines.
Consumer Product Packaging
Consumer goods, especially those sold online, are subject to the rigors of LTL transportation and the small parcel delivery system. Whether shipping from the manufacturer or distribution center to the store or the home of the end user, a packaged product is vibrated, stacked upon, dropped, baked or frozen the entire way. Distribution testing new of packaging designs per ISTA and ASTM methods can eliminate the headaches of damaged goods and lost business before they happen.
Package Performance Testing
Package strength testing generally refers to the package seal quality. Package strength concerns the force required to separate two components of the package. It could be the force to separate two flexible components of a pouch, or a flexible lid and a thermoform tray, or a measure of the compressive force exerted by an elastomeric closure onto a parenteral vial finish after capping. These forces may be measured in pounds per inch width, as in the seal/peel test per ASTM F88; or in pounds per square inch, as in package burst testing methods. Alone, these tests of package strength values do not necessarily prove the integrity of the entire package but serve to characterize and monitor package seal quality.
In the life sciences community, the term package integrity has many meanings. For medical device manufacturers complying with ISO 11607, package integrity is synonymous with sterile barrier packaging (SBS) integrity test methods. For drug product manufacturers, package integrity of parenteral packaging is the ability of a sterile product closure system to keep product contents in, while keeping detrimental environmental contaminants out. Such contaminants may include microorganisms, reactive gases, and other substances. The product includes the pharmaceutical formulation as well as the package headspace – which may consist of ambient air or nonreactive gases with a specified water-vapor content, under full or sub atmospheric pressure levels.
Sterile, parenteral package integrity is often referred to as Container Closure Integrity Testing, while medical device manufacturers refer to test methods for sterile barrier maintenance simply as Package Integrity Testing.
At the heart of effective and sustainable packaging design and performance are the component materials. The physical, and sometimes chemical, properties of the packaging materials are critical to informing the design process. We offer a wide variety of testing options when it comes to testing packaging materials. Capabilities include physical strength testing, packaging material qualification and identification, and characterizing material response to fatigue. Information gathered from these tests helps you plan the optimal packaging material choice in specific applications.
Label legibility is of principle concern to pharmaceutical and medical devices manufacturers. Our team evaluates your product labels for adhesion properties through temperature / humidity exposure of applied labels, peel resistance, and abrasion resistance. By incorporating label performance testing into the overall packaging development process, you can confirm your labels effectively communicate critical information and maintain their functionality throughout your product's shelf life.
Package Strength Testing
Package seal strength testing measures the force required to peel apart two bonded materials. These methods are applied to testing seals between two bonded, flexible materials, for example, a Tyvek lidded tray. The average force results provide a measure of seal strength between the bonded materials and the results are useful for monitoring the consistency of the sealing process over time.
Test method reference is ASTM F88.
The package burst testing is performed by internally pressurizing a test package and applying increased pressure until the package seal(s) burst. The package burst strength test result, reported in pressure units, provides an indication of relative seal strength and evaluates the most likely location and mode of package failure when the package is exposed to a pressure differential. Pressure differentials leading to seal failure may occur during the sterilization processes and transportation given the slow pressure and high altitude exposure.
Test method reference is ASTM F2054 or ASTM F1140 (with or without restraining plate fixtures).
The bubble emission test is a non-destructive method for detecting leaks in sealed packages. This test is ideal for identifying gross leaks (large openings) that compromise package integrity. We test your packaging with a controlled amount of inert gas, often helium or air, introduced into the package. The package is then submerged in a water bath. Any leaks present in the seal will allow the gas to escape and form bubbles on the water's surface. The presence and size of bubbles indicate the location and severity of the leak.
Test method reference is ASTM F2096 (Gross Leak Detection) or ASTM D3078 (Leaks Determination in Flexible Packaging).
Visual inspection is a crucial step in package strength testing. It allows for the detection of physical defects that may compromise package integrity. This analysis involves careful examination of seal integrity, material defects, contamination, and deformations. By combining visual inspection with other package strength testing methods, you can ensure your product packaging provides a robust barrier against contamination and damage throughout the product lifecycle.
Test method reference is ASTM F1886.
Package Integrity Testing
Regardless of whether you manufacture a sterile medical device or a parenteral drug product, package integrity should be reevaluated when changes are required in package design, package materials, or manufacturing and processing conditions. Our team supports your project in better understanding the testing requirements, the available test options, and how to execute package integrity testing projects on time and on budget.
Our Container Closure Integrity (CCI) Testing offers state-of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. CCI test programs optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages, and support regulatory submission applications for product commercialization around the world.
To maintain a packaged medical device product’s sterility until it reaches the point of end use, package designs need to incorporate a sterile barrier. Medical device manufacturers are required by regulatory agencies to follow ISO 11607 and demonstrate that the integrity of the sterile barrier is not adversely affected by distribution, storage, and handling throughout the expected shelf life.
The efficacy of the sterile barrier packaging materials and design must be evaluated after terminal sterilization and exposure to the environmental and dynamic stresses expected for the final packaging. Environmental conditioning, accelerated aging, and distribution simulation testing provide a controlled means to expose a package system to the anticipated environmental and dynamic stresses that sterile products may encounter in real world distribution. Package integrity testing, such as whole package bubble emission by vacuum, internal pressurization, or package seal dye penetration, provides the means to evaluate the efficacy of the sterile barrier packaging after exposure.
Test method reference is ASTM D3078, ASTM F2096, ASTM F1929, or ASTM F3039.
Closure application torque should be tested to designate an optimum application range to prevent leakage from loose closures and to prevent component distortion and compromised seals from a closure that may have been over-torqued. Application torque degrades over time due to a number of variables, including environmental factors. A properly designed and applied closure will retain sufficient sealing force until the package is opened at the time of use. Vacuum leakage testing and altitude simulation assist in the development process. Torque degradation studies assess how much closure retention torque may be lost after exposure to temperature cycling, compression, and vibration.
Test method reference is ASTM D4991, ASTM D6653, or ASTM D2063.
Often performed in conjunction with helium leak testing or vacuum decay leak testing, our team offers in-house parenteral vial capping and residual seal force testing of parenteral package systems. Residual seal force is not a leak test, but an indirect measure of the compressive force exerted by the stopper on the vial’s land surface.
A consistent and sufficiently significant RSF value provides a useful indicator of capping process consistency. A slow, constant rate of strain is applied to the top of a capped vial and the resistance to compression is monitored and reported. The appropriate amount of compressive force is required to ensure a quality seal. Vials capped at an insufficient force may leak from the sealing surface. On the other hand, vials capped at an excessive force may experience cracking and bulging, also risking the integrity of the closure system.
This nondestructive test checks seal quality by passing an ultrasound signal through a sealed area of the package. Poorly sealed areas do not transmit as much ultrasonic energy as properly sealed areas, which can be used to check for the presence and location of seal defects, such as incomplete seals, channels, wrinkles, seal contaminants, or weak bonds.
Package Materials Testing
Flexure testing is the most common, cost effective, and reliable packaging material strength test for brittleness flexure. Methods support the determination of flexural properties of unreinforced and reinforced plastics in three- and four-point bends.
Test method reference is ASTM D780 or ASTM F392.
Packaging materials behave differently in compression than they do in tension, so it can be important to perform tests which simulate the conditions the packaging material will see in actual use. Top load compression testing evaluates the package material performance to provide an indication of final packaging performance in storage and transport, which can help refine the final packaging material selection.
One of the most common ways of characterizing material strength is tensile testing. Packaging material is subjected to linear stress until failure or a critical attribute is attained. Tensile testing can be performed on many types of packaging materials to offer information about yield strength, ultimate tensile strength, modulus of elasticity (stiffness), and elongation.
Test method reference is ASTM D882 or ISO 527.
Puncture and impact testing assess the ability of film and packaging materials to withstand penetration forces. There are multiple packaging test methods to help define material properties based on the rate of energy delivered under controlled conditions Slow Rate Penetration yields a much different result than high speed pendulum impact test. In concert with puncture and impact testing, Tear Testing helps characterize the energy required to propagate a tear in packaging material.
Test method reference is ASTM F1306 or ASTM D3420.
Dye ingress testing provides a quick and inexpensive approach to evaluate your package for gross leaks, such as those caused by damage in a transit environment. This testing method offers a rapid detection method for gross leaks prior to pursuing more sophisticated, deterministic CCIT testing methods. The specific procedure for your product may be performed according to an existing standard or may be developed and validated for your specific package, as needed.
Test method reference is USP <381> and ISO 11040.
Peel testing is intended to determine the relative peel resistance of adhesive bonds, such as those between a package’s exterior surface and its label. Peel adhesion testing may be used to validate a change in labeling material or assess the impact of transit or environmental conditions on your label stock’s adhesive capabilities.
Test method reference is ASTM D1876, D6862, D3330, and D903.
Abrasion testing – also known as Sutherland Rub Test – is used to evaluate ink’s resistance to abrasion, scuffing, and smearing in a controlled environment. The performance of different labeling materials and technologies can be quantified for comparative purposes, for quality control of incoming materials, or for development purposes such as determining potential modes of failure. This test method is applicable to both human- and machine-readable printed materials.
Test method reference is ASTM D5264.
Package Label Testing
Label legibility is of principle concern to pharmaceutical and medical devices manufacturers. Our team evaluates your product labels for adhesion properties and abrasion resistance through temperature / humidity exposure of applied labels, peel resistance, and abrasion resistance.
Common methods include:
- ASTM D6252, Peel Adhesion of Pressure-Sensitive Label Stocks at a 90° Angle
- ASTM D6862, 90 Degree Peel Resistance of Adhesives
- ASTM D3330, Peel Adhesion of Pressure-Sensitive Tape
- ASTM D2979, Pressure-Sensitive Tack of Adhesives Using an Inverted Probe Machine
- ASTM D6195, Loop Tack
- FINAT Methods #1 – #9
- ASTM D5264, Abrasion Resistance of Printed Materials by the Sutherland Rub Tester
- PSTC Methods
- Attribute Inspections over Time
Distribution Testing
Distribution simulation testing provides a uniform and repeatable way of evaluating packaged products and packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.
Integrated Laboratory Services
When your team needs additional support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.