Simulated Distribution Testing for Effective Product Delivery
Packaged products must be able to withstand the typical events associated with manufacture, storage, and distribution without damage. Our expert team applies test methods from both ASTM and ISTA to support a wide variety of supply chain considerations. We offer both testing and certification to streamline your testing process.
Distribution simulation testing provides a uniform and repeatable way of evaluating packaged products and packaging designs by utilizing standardized equipment and procedures. During this process, we subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.
Partnering with our team offers access to a diverse range of expertise spanning project phases, product types, and business functions. Consider starting the conversation for more information about our services to provide the people power needed to achieve timelines and reach your objectives, whether that happens in your facilities or ours.
Supporting Various Products
Drug Products
Our comprehensive services include stability testing, container closure integrity, labeling verification and more. With our vast range of equipment and facilities, we apply the most relevant conditions to the testing procedures of your product to ensure the drug maintains potency and efficacy amidst transportation and storage.
Medical Devices
Ensure your product packaging protects against physical damage and environmental factors during distribution. Whether shocks, vibrations, moisture or temperature fluctuations present challenges, our team offers support identifying key concerns and providing alternative solutions when necessary. We also consider factors such as sterility maintenance and biocompatibility as part of our testing procedures.
Combination Products
Simplify your distribution testing with our team’s support determining the necessary evaluations for your combination product or drug-delivery device. We help predict regulatory expectations and ensure no adverse reactions or degradation occur between the drug, device, and packaging during distribution.
Consumer Goods
We help apply real-world distribution, packaging, and handling conditions to your product for simulated use testing. This evaluation helps ensure packaging remains functional without compromising the finished good.
Distribution Testing Services
Laboratory 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. Our package testing laboratory provides drop (shock), random vibration, loose load vibration and compression testing.
ISTA testing goes beyond basic package strength tests. It replicates the vibration, shock, compression, and climatic conditions a package will encounter during transportation. Our team applies a variety of standardized test profiles design for various product categories and shipping environments, which we offer guidance to select the most appropriate profile for your product and packaging configuration.
Environmental conditions vary depending on distribution channel, pathway, and provider, which is why our testing simulates extreme temperatures, humidity, and pressure fluctuations to prepare for effective storage and transportation. Partnering with our team to perform this testing helps ensure your product’s quality and safety, reduce risk of recalls, and provide data for regulatory compliance.
Maintaining product efficacy in cold chain shipments must be verified with thermal qualification testing. Shipping test evaluations ensure temperature-sensitive medical devices and drug products maintain potency and functionality throughout the logistics process. Our team provides the guidance and testing necessary to satisfy regulatory requirements and mitigate risks of compromised products.
Performance of the packaged product is typically assessed by 100% visual inspection. The specifics of the visual inspection procedure, the detail to which observations are documented, and the specific acceptance criteria may be established by a client protocol. Protocol drafting services are also offered by our experts.
Verify that critical dimensions are maintained for your product or packaging after simulated distribution testing. Our lab uses calipers, optical comparators, micrometers, and other measurement equipment to confirm that your materials comply with their specifications.
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 system (SBS) packaging 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 properties, and sometimes chemical properties, of the packaging materials need to be well understood by packaging engineers to aid in 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 plan the optimal packaging material choice in specific applications.
Label legibility is of principle concern to pharmaceutical and medical device 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
Package Distribution Testing Laboratories
Our laboratories host a series of environmental conditioning chambers with temperature ranges from -70° to 170°C with full relative humidity control. We can pre-condition your packages to simulate any shipping environment, including altitude simulation. Partner with our expert team to apply accurate shipping simulation conditions.
With advanced field data recorders, we monitor your real-time shipments for shock, vibration, temperature, humidity and pressure. The collected data allows for assessment and characterization of both the dynamic and atmospheric hazards present within measured transport and in-use environments. This information allows you to know exactly what your product is exposed to so you can adequately package it in a cost-effective manner.
As members of ASTM and ISTA, our teams are well versed in interpreting the applicable test standards. We offer consultation as early as the quotation process to ensure test sequencing and methods are fully understood and selected for your package design and intended distribution environment.
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.