Microbial barrier testing according to ASTM F1608

We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN 14683 standard. The tests included in the packages are required to label face masks with the CE marking. Medical face masks are divided into Types I and II according to their bacterial filtration efficiency. Type I masks are not intended for healthcare professionals, but for the public to prevent the spread of infectious diseases. Type II masks are further classified based on whether they are splash-resistant (Type IIR) or not (Type II). To comply with the European Standard EN 14683, Type II face masks must undergo the following quality tests: Bacterial filtration efficiency (BFE) - The ability of the face mask to filter the bacterium Staphylococcus aureus. The BFE is expressed as the percentage of colony-forming units (cfu) that have passed via aerosol through the facemask. If a face mask consists of two or more areas with different characteristics, these areas will be tested separately., Breathability (Differential pressure) - The amount of differential pressure required to draw air through a measured surface area at a constant flow rate., Microbial cleanliness (Bioburden) - The measurement of colony forming units per gram as per EN ISO 11737-1., Biocompatibility - The medical face mask manufacturer shall complete a biocompatibility evaluation according to ISO 10993-1 as a surface device with limited contact. The applicable toxicology testing regimen shall also be determined.. In addition to the above, Type IIR masks require the following test: Splash resistance - Performed according to ISO 22609, this test determines the ability of a face mask to resist penetration of splashes of liquid at different pressures.. The lower displayed price applies to the Type II mask test package, while the higher price also includes the splash resistance test required for Type IIR masks.

Standard ISO 22196 outlines a method for evaluating the antibacterial activity of plastics and other non-porous surfaces. The procedure involves inoculating the sample with a specified concentration of bacteria, typically Staphylococcus aureus or Escherichia coli, and incubating it under controlled conditions. After incubation, the number of viable bacteria on the test surface is compared to that on an untreated control surface. The difference is quantified as a logarithmic reduction, indicating the level of antibacterial activity. This method is widely recognized as reproducible and consistent, making it a reliable tool for assessing the efficacy of antibacterial treatments in industries such as healthcare, packaging, and consumer products. The lower end of the price range applies to testing with one bacterial strain, while the higher end includes analyses with both S. aureus and E. coli.

Sterility testing measures the growth of microorganisms on a product after the product has been sterilized. ISO 11737-2 is a harmonized standard for evaluating the sterility of medical devices by the EU Medical Device Regulation, as well as an FDA-recognized consensus standard for supporting 510(k) submissions. A sterile device or product is free from viable microorganisms. The purpose of sterilization is to inactivate microbiological contaminants to transform devices from a non-sterilized to a sterilized state. Sterility can be assessed when defining, validating, or maintaining a sterilization process. Testing according to ISO 11737-2 includes method validation by determining the initial bacterial count of control suspensions and testing the suitability of the culture media for aerobic and anaerobic bacteria and fungi. Also, the suitability of the test for the specific product is assessed. This example testing package includes the following: Testing of 3 identical specimens, Detecting the presence of aerobic and anaerobic microbes and fungi (yeast and molds), Validation of the sterility determination technique, The results are given as negative (no growth observed) or positive (growth observed). The price includes one result per micro-organism per product.. We can also offer a custom sterility test package for your needs, especially for large sample volumes. Please ask our experts for a quotation and estimated turnaround time

ASTM D4169 outlines test methods to simulate the stresses that shipping containers may encounter during handling, storage, and transportation. The standard is typically followed in the medical device industry to evaluate the ability of the outer packaging to protect the sterile barrier system (SBS), which in turn protects the enclosed device from microbial contamination. Some of the key tests covered by ASTM D4169 include: Drop testing, Vehicle stacking, Vibration testing, Pressure testing, Concentrated impact, Climatic conditioning. We are happy to prepare a custom offer for distribution testing, accounting for your packaging system's expected distribution environment, level of protection required, and the modes of transport used (air, land, and sea). Do not hesitate to request a quote using the form below.

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 the 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. Do not hesitate to contact us for a custom quote tailored to your project.

The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing plays a crucial role in the quality control of medical devices, pharmaceutical products, and their components. This analysis follows the ISO 11737-1 standard to detect populations of viable microorganisms on a product before sterilization, indicating the microbiological cleanliness of the product. ISO 11737-1 is recognized in the EU as a harmonized medical device standard and by the FDA as a consensus standard. This makes it the recommended way to evaluate bioburden under the EU MDR and the FDA 510(k) premarket submission process. This example testing package includes the following: Testing of 5 identical specimens, Detecting the presence of aerobic bacteria and fungi (yeasts and molds), Validating the bioburden determination technique, Results expressed as total CFU/test product (CFU=colony forming units), Tests under GLP. We can also offer custom bioburden test packages, especially for customers with large annual sample volumes. Please ask our experts for a quotation and estimated turnaround time.

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.

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, which 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.

Printing ink set-off can occur on the reverse side of printed labels, lids, cups, and packaging film, either in a stack or in the reel after printing. This creates a potential for low-molecular-weight substances to transfer to the unprinted surface of the packaging that makes contact with the packed contents. We offer two food simulant options for set-off testing: Ethanol solution for plastic and polymer-coated materials, Simulant E (Tenax) for the above and paper and board. The price includes a simple risk assessment based on the Swiss Ordinance for printing inks (SR 817.023.21), EU regulations for food contact materials, and EFSA's Threshold of Toxicological Concern (TTC) approach. More extensive risk assessment is available upon request.

ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed according to the standard are commonly used to demonstrate compliance with EU MDR and FDA requirements. The appropriate testing approach is chosen based on the body contact site: Skin irritation tests evaluate whether a medical device or material causes localized skin irritation when it comes into direct contact with the skin. Testing can be conducted using in vivo or in vitro methods, depending on the device and the market area. , Intracutaneous reactivity tests apply to medical devices or materials that penetrate the skin or come into contact with deeper tissues. The goal is to determine whether extracts from such devices cause localized inflammatory responses in the dermis or subcutaneous layers.. The device itself is tested with a direct contact method, when possible. Alternatively, polar and non-polar solvents are used to prepare extracts that simulate potential leachables from the device. The displayed example price includes an in vivo direct skin irritation test performed under GLP. For a more accurate quote, do not hesitate to contact us with a description of your device and any additional requirements you may have for testing (e.g., market area, quality systems, in vivo vs. in vitro methods).