Package, Product and Material Testing Services
Package, Product, and Material Testing
DDL has become the premier provider of package testing services for engineers` across the nation. When you need to know if your packaging will perform under pressure during shipment, operation and storage, turn to DDL`s team of tenured package engineers. DDL`s full-service testing laboratories in Eden Prairie, Minnesota, Fountain Valley, California and Edison, New Jersey will find the answers. DDL Inc. was established in 1990 by packaging engineers John Hart and Patrick Nolan. Backed by extensive equipment background, DDL provides package testing, product testing and comprehensive material testing services to manufacturers using mechanical testing and tensile testing methods. Familiar with national and industry-specific standards, our team of technical experts is equipped for testing to ensure that your packaging, product or material achieves official validation. DDL’s product testing services include catheter testing, luer testing, leak testing, cannulae testing, guide wire testing, needle testing, syringe testing, tracheal tube testing, compression testing, fatigue testing, flexural testing, peel adhesion testing and many more. We`re well-established experts in accelerated aging and shelf-life studies to distribution simulation and exploration of physical package integrity and package strength. DDL has a full service dynamic and integrity lab in all three locations along with chamber space ranging from 1 cubic foot to 1,000 cubic feet per chamber. DDL’s location in Eden Prairie, MN has 55 chambers alone. Apart from the medical device industry, DDL also works with clients in the chemical, electronics, mechanical, aerospace, consumer products, packaging and automotive industries as well as research labs. DDL has the experience and the knowledge to guide you to the right standard and help you better understand your testing and your results. We pride ourselves on excellent customer service, accurate data reporting, quick turn around time, and failure analysis. Our packaging engineers have years of experience in the medical device industry and are here to answer any questions you have about regulatory compliance Click here for more information about DDL's package testing, product testing, and material testing services.
DDL has become the premier provider of package testing services for engineers` across the nation. When you need to know if your packaging will perform under pressure during shipment, operation and storage, turn to DDL`s team of tenured package engineers. DDL`s full-service testing laboratories in Eden Prairie, Minnesota, Fountain Valley, California and Edison, New Jersey will find the answers.
DDL Inc. was established in 1990 by packaging engineers John Hart and Patrick Nolan. Backed by extensive equipment background, DDL provides package testing, product testing and comprehensive material testing services to manufacturers using mechanical testing and tensile testing methods.
Familiar with national and industry-specific standards, our team of technical experts is equipped for testing to ensure that your packaging, product or material achieves official validation. DDL’s product testing services include catheter testing, luer testing, leak testing, cannulae testing, guide wire testing, needle testing, syringe testing, tracheal tube testing, compression testing, fatigue testing, flexural testing, peel adhesion testing and many more.
We`re well-established experts in accelerated aging and shelf-life studies to distribution simulation and exploration of physical package integrity and package strength. DDL has a full service dynamic and integrity lab in all three locations along with chamber space ranging from 1 cubic foot to 1,000 cubic feet per chamber. DDL’s location in Eden Prairie, MN has 55 chambers alone.
Apart from the medical device industry, DDL also works with clients in the chemical, electronics, mechanical, aerospace, consumer products, packaging and automotive industries as well as research labs.
DDL has the experience and the knowledge to guide you to the right standard and help you better understand your testing and your results. We pride ourselves on excellent customer service, accurate data reporting, quick turn around time, and failure analysis. Our packaging engineers have years of experience in the medical device industry and are here to answer any questions you have about regulatory compliance
Click here for more information about DDL's package testing, product testing, and material testing services.
Package Validation
Package testing and package validation are essential for getting your product to the market. DDL’s 20 plus years working with clients across the US provides us with authoritative expertise, superior testing services and competitive project quotes. Distribution simulation tests evaluate each package’s ability to protect the product devices without defect or loss of sterility throughout the handling, distribution and storage environment. ASTM D 4169 Standard Practice for Performance Testing of Shipping Containers and Systems is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (e.g. shock, drop, vibration, compression) which are encountered in various distribution environments. The Distribution Cycle (DC) most commonly used for medical device packages is DC 13 which is designed for the small parcel and overnight shipping mode. ISTA (International Safe Transit Association) Pre-Shipment Test Procedure is a series of tests that predetermine the probability of the safe arrival of packaged products at their destination through tests that simulate the shocks and stresses encountered during handling and transportation. Physical Package Integrity Tests: To maintain the sterility of an enclosed product until it reaches its point of end use, the packaging must provide a microbial barrier in the post-sterilization environment. Sterile package integrity must be maintained under the rigors of distribution, storage, handling and aging for the claimed shelf-life of the medical device. Tests used to satisfy these requirements evaluate the material performance and the whole, finished package. ASTM F 1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. The exposure chamber method determines the microbial barrier properties of porous materials, which helps assess the potential of a one porous material to contribute to the loss of sterility of the contents of the package in comparison with that of another porous material. Intact Package Microbial Barrier Test (Porous Packages) is used to evaluate the ability of an intact, production package to maintain its sterile environment until it reaches its point of end use. The procedure includes an aerosol challenge in a test chamber, package exterior decontamination, and subsequent sterility testing to determine the presence of the indicator organism. Microbial Ingress for Non-Porous Packages (Immersion Challenge Method) is a method to asses the ability of a non-porous package to provide a microbial barrier. Packages containing sterile growth medium are immersed in a buffer solution containing a known concentration of an indicator organism. After the challenge, the packages are dried under laminar flow, then incubated and inspected for growth of the indicator organism. Physical test methods (shock testing, vibration testing, mechanical testing, leak testing) may be used to validate that physical package integrity has been maintained throughout the packages processing, expected shelf life, and handling. They include ASTM F 1929 Package Leak Testing by Dye Penetration and ASTM D 3078 Package Leak Testing by Bubble Emission.
Package testing and package validation are essential for getting your product to the market. DDL’s 20 plus years working with clients across the US provides us with authoritative expertise, superior testing services and competitive project quotes.
Medical Device Package Testing
DDL is a full service testing lab specializing in medical device package, product and material testing. We have years of experience in the package validation testing (ISO 11607) industry. DDL has been a national leader and innovator in the testing industry since 1990. Our certified packaging engineers and three full-service testing laboratories will provide the expertise to validate the efficacy of your packaging systems. We offer single source solutions to medical device development engineers, Q&A and regulatory affairs professionals who are concerned that their devices meet all regulatory agency requirements. Medical device manufacturers are required to obtain 510(K) approval on each medical device and its packaging. DDL performs Physical Package Integrity Testing (See Package Testing & Package Validation). The Testing services include: Package Leak Testing by Vacuum (ASTM D3079-02, ASTM D4991-94) Package Leak Testing by Dye Penetration (ASTM F 1929) Package Leak Testing by Bubble Emission (ASTM D 3078) Package strength testing evaluates the strength characteristic to produce acceptable packages on a daily basis and throughout a determined shelf-life validation. It allows the medical device manufacturer determine that their process for sealing packages is consistent with their predetermined specification in the process validation. The main culprit for poor package strength is the seal sealing parameters. If a proper process validation of the sealer is not performed, the medical device manufacturer can expect failure. Package strength is the force required to separate two components of the package, for e.g. pouch, flexible lid or thermoform tray. These forces may be measured in pounds per inch width, as in the seal/peel test; or in pounds per square inch, as in the burst test method. Alone, these tests of package strength do not necessarily prove the integrity of the entire package. The seal width measured may be within the strength specification but may have a channel leak that could breach the package and negate its integrity. Typical package strength testing includes:- Package Strength Testing by Seal Peel Testing: ASTM F88-00 - Package Strength Testing by Burst Testing: ASTM F-1140-00- Package Strength Testing by Peel Adhesion Testing: ASTM D 3330 DLL also offers clients Transportation & Distribution Simulation Testing Services (See Package Testing & Package Validation) Accelerated aging is performed on packaged medical devices to document a conservative shelf life and expiration times for products. Real time aging can be performed; however, products are often obsolete by the time a three-year expiration date is validated. The European Medical Device Direction (MDD) implies that all sterile medical devices must have an expiration date, meaning documented shelf-life evidence must exist to substantiate those claims. Accelerated aging is based on a thermodynamic temperature coefficient formulated by Von't Hof that states `for every 10 degree C rise in temperature the rate of chemical reaction will double.` But this formula was based on rate kinetics of a single chemical reaction, not on packages with various kinds of materials. So, its direct extrapolation to the aging of packaging materials must be used with caution. The testing services that DDL uses for simulating the typical events associated with the distribution environment include published ASTM standards and other industry test methods. ASTM D 4169: Standard Practice for Performance Testing of Shipping Containers and Systems: This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (eg. shock, drop, vibration, compression) which are encountered in various distribution environments. The test plan provides a uniform basis of evaluating, in a controlled and repeatable laboratory environment, the ability of the shipping units and contents to withstand the distribution environment. The test plan uses established testing services methods at levels representative of those encountered in actual distribution. The Distribution Cycle (DC) most commonly used for medical device packages is DC 13 which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined. Sample Size: The optimum sample size is ten shipping units with the primary packages assembled as intended for shipment. ISTA Pre-Shipment Test Procedure for Packages: These testing services provide a means for a manufacturer to predetermine the probability of the safe arrival of their packaged-products at their destination through the utilization of tests developed to simulate the shocks and stresses normally encountered during handling and transportation. Sample Size: The optimum sample size is ten shipping units with the primary packages assembled as intended for shipment. Temperature selection for the accelerated aging should be determined by avoiding unrealistic failure conditions such as deformation due to melting. Real time aging must be performed in conjunction with any accelerated aging study to correlate the results found during accelerated aging. Tolerances for the temperature and humidity are provided to only ensure that the test chamber operates within a satisfactory range. Out of tolerance excursions (caused by opening doors for sample transfer; inserting moist samples into a dry environment, proximity of monitoring device to temperature and/or humidity source, etc.) for less than 6 hours for either temperature or humidity are acceptable and do not adversely affect the estimate for shelf life. As regulators increasingly look for proof of pharmaceutical product stability throughout the supply chain, it is critical for manufacturers to ensure stable temperatures and endure handling from warehouse -- to transit -- to shelf. Thermal Performance Testing: From highly controlled cold chain package testing facilities DDL tests thermal packaging for pharmaceutical companies. Within 72 – 120 hours, DDL can conduct an accelerated stability test and develop a specification designed to inform clients of conditions that will push a thermal container out of the 2-8 centigrade (an indication that contents may loose active ingredients or even spoil) desired shipping and storage temperature.
DDL is a full service testing lab specializing in medical device package, product and material testing. We have years of experience in the package validation testing (ISO 11607) industry.
DDL has been a national leader and innovator in the testing industry since 1990. Our certified packaging engineers and three full-service testing laboratories will provide the expertise to validate the efficacy of your packaging systems. We offer single source solutions to medical device development engineers, Q&A and regulatory affairs professionals who are concerned that their devices meet all regulatory agency requirements. Medical device manufacturers are required to obtain 510(K) approval on each medical device and its packaging.
DDL performs Physical Package Integrity Testing (See Package Testing & Package Validation). The Testing services include:
Package strength testing evaluates the strength characteristic to produce acceptable packages on a daily basis and throughout a determined shelf-life validation. It allows the medical device manufacturer determine that their process for sealing packages is consistent with their predetermined specification in the process validation.
The main culprit for poor package strength is the seal sealing parameters. If a proper process validation of the sealer is not performed, the medical device manufacturer can expect failure.
Package strength is the force required to separate two components of the package, for e.g. pouch, flexible lid or thermoform tray. These forces may be measured in pounds per inch width, as in the seal/peel test; or in pounds per square inch, as in the burst test method. Alone, these tests of package strength do not necessarily prove the integrity of the entire package. The seal width measured may be within the strength specification but may have a channel leak that could breach the package and negate its integrity.
Typical package strength testing includes:- Package Strength Testing by Seal Peel Testing: ASTM F88-00 - Package Strength Testing by Burst Testing: ASTM F-1140-00- Package Strength Testing by Peel Adhesion Testing: ASTM D 3330
Accelerated aging is performed on packaged medical devices to document a conservative shelf life and expiration times for products. Real time aging can be performed; however, products are often obsolete by the time a three-year expiration date is validated.
The European Medical Device Direction (MDD) implies that all sterile medical devices must have an expiration date, meaning documented shelf-life evidence must exist to substantiate those claims. Accelerated aging is based on a thermodynamic temperature coefficient formulated by Von't Hof that states `for every 10 degree C rise in temperature the rate of chemical reaction will double.` But this formula was based on rate kinetics of a single chemical reaction, not on packages with various kinds of materials. So, its direct extrapolation to the aging of packaging materials must be used with caution.
The testing services that DDL uses for simulating the typical events associated with the distribution environment include published ASTM standards and other industry test methods.
ASTM D 4169: Standard Practice for Performance Testing of Shipping Containers and Systems: This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (eg. shock, drop, vibration, compression) which are encountered in various distribution environments. The test plan provides a uniform basis of evaluating, in a controlled and repeatable laboratory environment, the ability of the shipping units and contents to withstand the distribution environment. The test plan uses established testing services methods at levels representative of those encountered in actual distribution. The Distribution Cycle (DC) most commonly used for medical device packages is DC 13 which is designed for the small parcel and overnight shipping mode.
Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.
Sample Size: The optimum sample size is ten shipping units with the primary packages assembled as intended for shipment.
ISTA Pre-Shipment Test Procedure for Packages: These testing services provide a means for a manufacturer to predetermine the probability of the safe arrival of their packaged-products at their destination through the utilization of tests developed to simulate the shocks and stresses normally encountered during handling and transportation.
Temperature selection for the accelerated aging should be determined by avoiding unrealistic failure conditions such as deformation due to melting. Real time aging must be performed in conjunction with any accelerated aging study to correlate the results found during accelerated aging.
Tolerances for the temperature and humidity are provided to only ensure that the test chamber operates within a satisfactory range. Out of tolerance excursions (caused by opening doors for sample transfer; inserting moist samples into a dry environment, proximity of monitoring device to temperature and/or humidity source, etc.) for less than 6 hours for either temperature or humidity are acceptable and do not adversely affect the estimate for shelf life.
As regulators increasingly look for proof of pharmaceutical product stability throughout the supply chain, it is critical for manufacturers to ensure stable temperatures and endure handling from warehouse -- to transit -- to shelf.
Thermal Testing and Monitoring
DDL has the team of industry experts and the equipment capacity to conduct and mange your thermal performance testing projects from the protocol development phase through to the execution of the protocol and final documentation. Working as an independent third party lab or in conjunction with our own team of engineers and designers, DDL has the expertise and expanded capacity to perform all your thermal performance testing requirements. We handle everything from protocol development, protocol execution and final documentation. DDL Labs are the industry leaders in providing qualification testing that stands up to regulatory audits. Our Thermal Performance testing capabilities includes: More than 20 fully programmable thermal test chambers worldwide, ranging in temperature capabilities from -35C to 80C and sizes from 36 inch cube up to our larger walk ins that can hold up to six 40 x 48 pallets. Data acquisition equipment calibrated to NIST traceable standards for accurately recording temperature with an accuracy of up to 0.2 C and a resolution of 0.01. Remote monitoring capabilities Storage and conditioning units ranging from -23C to 5C for optimal preconditioning Cold room assembly of your project to ensure proper conditioning A Project Manager is assigned to your project and dedicated to manage the scope of the project accurately and on a timely basis. Complete validation and qualification of Thermal packaging systems. Pre and post calibrations of the monitoring equipment Comprehensive, industry-guided test reports that conform to FDA, USDA, and HACCP guidelines. Our MN, NJ, and CA locations are ISO9000:2001 certified ISTA Certified Lab following a cGMP methodology, conforming to PDA Technical Report No. 39, ISTA and ASTM standards Complete distribution testing capabilities to ISTA and ASTM standards. MKT, K and R value calculations of your data and test materials Test Report documentation includes: Summary: overview of the test plan and objective, including scope, acceptance criteria, test set-up, product acceptance criteria, and summary data tables Test Data: color graphs and raw data for all tests performed Packing Procedures: written and illustrated instructions for each packing configuration tested. Material Descriptions and Specifications: engineering specifications for all packaging components Equipment Description and Calibration Data: full documentation for all equipment used in the qualification Protocol: includes a purpose, scope, responsibility, test procedure, and acceptance criteria Thermal Package Design and SupportOur team of packaging engineers who specialize in thermal packaging testing and thermal packaging design are on staff to assist in refining your packaging that under-performs or provide a new package design that not only meets your package design requirements but is optimized to save on packaging costs and the environmental impact of the packaging.
DDL has the team of industry experts and the equipment capacity to conduct and mange your thermal performance testing projects from the protocol development phase through to the execution of the protocol and final documentation.
Working as an independent third party lab or in conjunction with our own team of engineers and designers, DDL has the expertise and expanded capacity to perform all your thermal performance testing requirements. We handle everything from protocol development, protocol execution and final documentation. DDL Labs are the industry leaders in providing qualification testing that stands up to regulatory audits.
Our Thermal Performance testing capabilities includes:
Test Report documentation includes:
Thermal Package Design and SupportOur team of packaging engineers who specialize in thermal packaging testing and thermal packaging design are on staff to assist in refining your packaging that under-performs or provide a new package design that not only meets your package design requirements but is optimized to save on packaging costs and the environmental impact of the packaging.
Packaging Material Testing
Test the materials that make up your package. To compliment DDL’s Medical Device Packaging Testing, DDL’s Product and Materials Division can take your package design testing to a deeper level by testing the materials that make up the package itself. From tensile and tear testing of poly films and trays to compression and bending of packaging components, materials testing at DDL can help you better understand your options and will allow you to make more informed decisions on your packaging materials. Processing variables, proposed vendor changes, effects of aging, different sterilization treatments and different material sources can all be explored through material testing. The engineering and technical staff at DDL’s Product and Materials Division has a thorough understanding of today’s test standards and provides reports with accurate results which give you a high confidence level in your important, packaging materials choices. DDL can test to ASTM, ISO, TAPPI, military and other recognized industry standards. DDL can also help you create test protocols and custom test methods specific to your needs. Test Types Materials 3 Point Bend/Flexural AdhesivesAdhesion StrengthAir PermeabilityCoefficient of Friction CardboardCompressionEdge CrushEnvironmental Performance Ceramics/GlassFatigueFlow Rate CompositesFragility Construction MaterialsLeakage CorrugatedMullen Burst FastenersPeel Adhesion FoamPucture/Impact MetalShear Paper and Board Shock Plastics and FilmsTear Pressure Sensitive AdhesivesTensile SiliconeThermal Performance Stretch WrapVibration TapesVisual Inspection Textiles Tyvek
Test the materials that make up your package.
To compliment DDL’s Medical Device Packaging Testing, DDL’s Product and Materials Division can take your package design testing to a deeper level by testing the materials that make up the package itself. From tensile and tear testing of poly films and trays to compression and bending of packaging components, materials testing at DDL can help you better understand your options and will allow you to make more informed decisions on your packaging materials.
Processing variables, proposed vendor changes, effects of aging, different sterilization treatments and different material sources can all be explored through material testing. The engineering and technical staff at DDL’s Product and Materials Division has a thorough understanding of today’s test standards and provides reports with accurate results which give you a high confidence level in your important, packaging materials choices.
DDL can test to ASTM, ISO, TAPPI, military and other recognized industry standards. DDL can also help you create test protocols and custom test methods specific to your needs.
Test Types Materials
3 Point Bend/Flexural AdhesivesAdhesion StrengthAir PermeabilityCoefficient of Friction CardboardCompressionEdge CrushEnvironmental Performance Ceramics/GlassFatigueFlow Rate CompositesFragility Construction MaterialsLeakage CorrugatedMullen Burst FastenersPeel Adhesion FoamPucture/Impact MetalShear Paper and Board Shock Plastics and FilmsTear Pressure Sensitive AdhesivesTensile SiliconeThermal Performance Stretch WrapVibration TapesVisual Inspection Textiles Tyvek
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