DDL, INC.

Package, Product, and Material Testing

DDL has become many engineers` first choice for quality package testing services. 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, and Costa Mesa, California 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 is equipped for testing to ensure that your packaging, product or material achieves official validation. DDL product testing services include environmental testing, leak testing, material testing, mechanical testing, package testing, shock testing, vibration testing, accelerated testing and shelf life validation.

We`re well-established experts in medical device package testing, offering a full range of package testing and environmental testing services... from accelerated aging, shelf-life studies and microbial barrier testing to transportation simulations and exploration of physical package integrity and package strength. DDL Inc. has established a medical device package testing facility in Costa Mesa, California to serve Southern California`s booming biomedical industry.

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.

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Package Validation

Package testing and package validation are essential for getting your product to the market. Our labs work with clients provides authoritative expertise, superior testing services and fixed-base 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.

Material Product Testing

DDL offers a wide range of material product testing services that draw from best practices testing techniques and use an extensive equipment background which enables us to measure mechanical properties, conduct material characterization analysis, aid in materials selection, serve as a packaging design authority, add value to quality initiatives and produce product performance tests.

With an extensive background in servo control, DDL engineers can control testing equipment in a way that enables real life simulation of material conditions. DDL material testing capabilities cover strength testing and characterization of material response to fatigue.

• Flexure tests, the most common, cost effective and reliable of the tests for brittle material strength, is a three- and four-point flexure.
  
• Compression tests are conducted because materials behave differently in compression than they do in tension. Fixture and transducer tests, which simulate conditions the material are exposed to in actual use, are performed. Compression testing is performed on plastics, foam, rock, concrete and asphalt. It is also used to evaluate the behavior of finished products. For example, a hypodermic needle may be pushed into a material to see how easily it penetrates and assess its sharpness.
  
• Tensile strength tests, a realistic representation of the stress the material will experience during actual application, are applied to polymers, elastomers, metals, composites, ceramics and rock.
  
• Fatigue tests are performed for specimens used in structural applications where repetitive loads and strains require confirmation that the chosen material is appropriate.
  
• Performance tests, often referred to as product or material tests, verifies whether designs can meet the type of mechanical durability and performance for which they were designed.

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Product Package Testing

DDL can assist you in testing product performance, including the dynamic and environmental hazards inherent in the environments in which they`re operated and used. We can test products for their shock fragility and durability using industry standard methods, including ASTM, IEC, military and governmental standards. We also act as consulting engineers, helping you solve any problem identified by your test results.

• Vibration testing are common cost-effective and reliable tests to determine the mechanical durability of electronics and other products. They are used to test packages for transportation and also help in product design. The methods used are:

                         ASTM Methods D 999, D 3580, D 4728
                         Mil Standard Methods 810 e, 167, 202
                         Federal Test Method 101
                         Sine and random closed loop control
                         Real-time simulation

• Shock testing is used to test electronic, military and automotive products for mechanical fragility. Drop simulation tests verify that the consumer products function per expectations. The tests may also be accompanied by extensive failure analysis reports. 

                         Controlled shock inputs
                         Shock response spectrum (SRS)
                         Multi-channel data acquisition
                         Damage boundary
                         Fragility assessment
                         Halfsine and squarewave pulses

• Compression testing involves the following protocols

                         ASTM D 642, D 4169
                         Pallet and package size testing capabilities

• Environmental simulations are carried out as many products need to be tested to certify their ability to handle exposure to real thermal and humidity environments. Environmental simulation is common to the electronics, automotive, medical device, aerospace and packaging industries. Combined mechanical and electrical tests are needed to confirm integrated system level performance for many products. Resistivity, insulation and resistance tests are common.
             ASTM D 4332
             Thermal shock
             Temperature profiles
             Temperature altitude
             Accelerated aging

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Medical Device Package Testing

DDL is your one stop source for medical device testing and validation for products, materials and packaging. DDL has been a leader and innovator in the medical device testing industry since 1990. 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 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. So 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.

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.
  

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Hazardous Material Package Testing

When shipping dangerous goods by ground, water or air, it is imperative to know that hazardous material packaging has the utmost integrity. Packages with integrity can help reduce the likelihood of hazardous accidents This same type of packaging can also reduce the chance that shipments will be rejected by overseas customs for non-compliance. So packages have to be rigorously tested for compliance to regulations developed by the UN, US Department of Transportation and International Maritime and International Civil Aviation Organizations.

DDL has been testing packaging of hazardous materials since 1990. DDL engineers working in well-equipped test facilities deploy a series of dynamic and static Hazmat tests designed to determine if the package meets compliance standards. Compliance testing includes calibrated drop, shock and stacking, electro-hydraulic vibration, compression, dead-load weight, internal pressure, leak and variation.

DDL Hazmat tests are typically deployed over a seven-day period. Special handling testing, however, can be expedited to a three-day turn around. DDL documents the results of all Hazmat tests both photographically and in written form. A final test report includes certification information required for ground, air and water transportation of hazardous materials. This information helps clients meet the requirements of the following regulations:

UN Recommendations on the Transport of Dangerous Goods, Chapter 9 D.O.T. Title 49
International Civil Aviation Organization (ICAO) Technical Instructions

International Maritime Organization`s (IMO) International Maritime Dangerous Good Code (IMDG).

Example: A 4G-combination package requires eleven complete packages. The packages are prepared as they would be for normal shipping, except that the inner containers are filled a non-hazardous substance -- usually water. The packing group and product density of the actual filler determines performance levels used for testing. The following tests are performed on a 4G-combination package.

• Cobb Water Absorption Test is performed on the corrugated box in accordance with ISO 535 & 49 CFR §178.516. Samples are conditioned at ambient conditions (73ºF/50% RH) for 24 hours prior to testing, which consists of a 30-minute soak in water. Five samples are prepared for this test.
  
• Drop Test involves five packages being dropped from the required drop height. Each sample is dropped once, in five different orientations, for a total of five drops. Primary inner packages (i.e. bottles) made of plastic are conditioned to 0ºF for 24 hours prior to testing. All other inner package materials are conditioned at ambient conditions (73ºF/50% RH) for 24 hours prior to testing. Reference: UN §5.1.6.3 and 49 CFR §178.603.
  
• Stack Test is performed on three complete packages by loading each individual box with a weight equivalent to a 3-meter stack of identical boxes. This test may be performed with or without the primary inner packages (i.e. bottles). The test duration is 24 hours per sample. Samples are conditioned at ambient conditions (73ºF/50% RH) for 24 hours prior to testing. Reference: UN §5.1.6.6 and 49 CFR §178.606.
  
• Vibration Test is performed on three complete packages and requires the operator to determine the acceleration needed to cause the package to leave the surface of the test table. This is accomplished by increasing the frequency of the shaker until the package separates enough so that a 1/16-inch shim can slide between the package and the table surface. Once the test level is determined, the test duration is one hour. Samples are conditioned at ambient conditions (73ºF/50% RH) for 24 hours prior to testing. Reference: 49 CFR §178.608.

Optional Tests:

• Hydrostatic Pressure Test is performed on three primary inner packages (i.e. bottles) by pressurizing the bottles to the required pressure with water for a specified duration. This test is only required for inner packages that contain liquid and will be shipped by air. Testing is performed on three samples, including the closures. Reference: UN §5.1.6.5 and 49 CFR §178.605.
  
• ISTA Test is a drop test and vibration test performed on three complete package designs. A ten-drop sequence and loose load vibration test are performed. This test is only required if UPS will be used to ship your package design containing hazardous materials.

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