Distribution testing of shipping containers and systems by ASTM D4169

Horizontal impact testing by the ISO 2244 standard is used to determine the effect of a vertical impact on the horizontal edge of finished and filled cardboard containers. In the test, the packaging is placed on a carriage that is rolled against an impact apparatus. Testing can include a single test or a series of impact tests to evaluate the packaging's ability to perform in environments with a horizontal impact hazard.

Imaging of the sample using scanning electron microscopy (SEM). Typically, several images are taken with varying magnifications to get a good overview of the sample. Non-conductive samples can be prepared with a metallic coating to allow imaging. For cross-section measurement, additional preparation might be needed: FIB, BIB or freeze fracturing. If compositional analysis is also needed, please see the SEM-EDX measurement.

ASTM F1980 establishes a standardized approach for accelerated aging of medical device sterile barrier systems (SBS), either with or without devices. Accelerated aging studies help manufacturers assess the shelf life of the product more rapidly than real-time aging studies. The results may be used as a preliminary indication of a product’s stability and packaging integrity until real-time aging results become available. This approach aligns with regulatory expectations, including FDA guidance (21 CFR - Process Validation) and ISO 11607-1. In accelerated aging studies, materials are exposed to elevated temperatures for a shorter period, simulating the effects of real-time aging. Based on the results, manufacturers can estimate how long the packaging will maintain its protective properties under real-world storage and transportation conditions. Product stability can be evaluated both upon completion and throughout the aging process using various methods. The assessed properties are selected based on the manufacturer’s specific requirements and regulatory considerations, and they may include the following: Sterility, Mechanical performance (e.g. shear, tensile, and compression strength), Chemical properties (e.g. product degradation). Measurlabs can provide accelerated and real-time aging in parallel. We can also help with stability and integrity testing during and after the aging period.

The ASTM F1608 method is used to determine the passage of airborne bacteria through porous materials used in the packaging of sterile medical devices. With the test, different materials can be compared to determine which one offers the best protection against contamination. A mist of bacteria spores (Bacillus atrophies) is sprayed on the porous testing material in an exposure chamber. Spores that get through the material are trapped on a special filter and counted. The number of spores sprayed originally is compared to the number of spores that got through to conclude how well the material blocks the bacteria.  The results are expressed as a “Log Reduction Value” (LRV), representing the effectiveness of the material in preventing bacteria from passing.

This method is used to determine the flat crush resistance of a corrugating medium after being fluted to A-flute geometry with a laboratory fluting device. The Concora corrugating medium test can be used for any corrugating medium that is intended to be used on a corrugated board.

Cyclosiloxanes are the primary building blocks of siloxane polymers and, ultimately, silicone rubber. Hence, cyclosiloxanes can remain in the final silicone article as residual impurities. Several cyclosiloxanes (D4, D5, D6; see table below) are considered harmful to the environment and human health. These three substances are listed in the REACH Candidate List of substances of very high concern (SVHC). Substance Abbreviation CAS N:o Octamethylcyclotetrasiloxane D4 556-67-2 Decamethylcyclopentasiloxane D5 541-02-6 Dodecamethylcyclohexasiloxane D6 540-97-6 The Nordic Swan Ecolabel criteria for greaseproof paper sets the limit values for D4, D5, and D6 impurities in silicone coating as 400 ppm per substance and 1000 ppm for the sum of D4, D5, and D6. In addition to the restricted substances listed above, this analysis package includes the quantification of cyclosiloxanes D3, D7, and D8.

This test is used to determine the folding endurance of paper or board using the Köhler-Molin, Lhomargy, MIT, and Schopper testers. During the test, a narrow strip of paper is folded forwards and backward in a standardized manner, so that it is subjected to longitudinal stress until it breaks.

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are not exposed to pathogens. Depending on the device’s intended use and classification, appropriate reprocessing steps may include cleaning, disinfection, and/or sterilization. For cleaning validation more specifically, the testing procedure consists of three steps: Simulated contamination with artificial soils that accurately reflect clinically relevant soils, such as blood and other bodily fluids. , Cleaning (manual and/or automated), carefully following the manufacturer's instructions for parameters such as detergents, cleaning tools, water quality, and temperature. , Inspection, both visually and using quantitative methods relevant to the test soil (e.g. proteins, total organic carbon, or hemoglobin) to assess whether residual contaminants remain on the device.. Successful cleaning validation is often sufficient for non-critical reusable devices, such as blood pressure cuffs, monitors, and clutches. Semi-critical and critical devices will require further disinfection and/or sterilization validation studies that we can also offer. The displayed example price covers a manual cleaning validation study with 6 reprocessing cycles and cleanability evaluations with visual inspection & protein content measurement. Test protocol formulation and reporting are also included.

A dilatometer is used to determine the linear thermal expansion of a material as a function of temperature. The temperature range of the measurement is generally between 25 °C and 1,600 °C. There is also an option to perform the test in a cryogenic atmosphere, which ranges from -175 °C to 300 °C. The typical heating rate is 3 °C/min. As a result of the measurement, you will get the coefficient of thermal expansion (CTE) and the absolute change in sample length, both as a function of temperature. The testing can be performed in various atmospheres, including air, argon, CO₂, N₂, and O₂. Please contact us to get a quote. The price will depend on the testing conditions, so please specify them as precisely as possible.

Bending stiffness testing is performed to evaluate cardboard's stiffness by measuring the resistance to bending with 4-point loading. The results express the bending stiffness of the material in the machine direction and the cross direction.