What is the ASTM F838 test of filter membrane
Issuing time:2023-08-22 10:50
The ASTM F83 test mentioned here should be ASTM F83-15a related to the filter membrane. ASTM F838-15a is a standard test method developed by ASTM International (formerly known as the American Society for Testing and Materials) to evaluate the use of water purification systems. The bacterial retention performance of membrane filters, which is widely considered the gold standard for evaluating a filter's ability to produce sterile wastewater when challenged with bacteria.
The ASTM standard in the United States is an organization that develops and publishes voluntary consensus standards for various materials, products, systems and services. It represents the American Society for Testing and Materials, now known as ASTM International. ASTM standards cover various industries and sectors, including construction, Manufacturing, petroleum, environmental science, medical devices, etc. These standards provide guidelines and specifications for testing, performance evaluation and quality assurance in different fields, and are widely recognized and used internationally as quality assurance, product testing and compliance with regulations and A reference to industry best practices, it includes ASTM F838-15a, which is widely used and referenced across industries in the United States, and in healthcare, the standard may apply to medical devices, pharmaceutical manufacturing, and other related areas.
Based on the reliability and practicability of the ASTM F838-15a standard, it has become a country that adopts or refers to international standards as part of its regulatory framework. For example, in the European Union, medical devices and related standards are regulated by the European Medicines Agency (EMA) and the European Commission , the European Union has its own regulations and standards for evaluating the performance of filters and medical devices, such as the European Pharmacopoeia (Ph. Eur.) and ISO standards. ), also refer to and quote international standards (including ASTM) to evaluate the performance of liquid filters in medical applications on top of their own standards, so the application of ASTM F838-15a or similar standards in other countries/regions may have vary depending on the requirements of respective regulatory agencies, industry practices and local standards organizations.
The necessity of the ASTM F838-15a standard test, then, does every type of membrane need to accept the ASTM F838-15a test, this is not absolute, it depends on the intended use of the filter membrane, the practicality of the standard means Safety, and meeting these standards requires a relatively large cost. Therefore, in the pharmaceutical industry, medical equipment or water treatment industries such as drinking water, various types of filtration membranes used in applications where bacterial retention is important, it involves In the field of personal life safety, it is generally considered necessary to carry out ASTM F838 testing to ensure that the performance of the filter (membrane) in terms of intercepting bacteria meets the expected standards and prevent possible serious consequences due to bacterial contamination. For other applications where bacterial retention is less important, in order to ensure economic benefits, save costs, and not cause direct and indirect health and safety problems, it can be used or not used as appropriate.
What is the main test principle and content of ASTM F838 15a? Its main principle is to challenge the filter membrane (device) with a bacterial suspension and measure its ability to retain bacteria. For example, Brevundimonas diminuta bacteria are used as test microorganisms with a diameter of about 0.3 μm. The test filter is subject to Challenge of high concentrations of B. diminuta (at least 10^7 organisms per square centimeter of filter area) in water-based materials, then collect the filtrate and test for the presence of B. diminuta, acceptable test results, the bacterial retention efficiency of the filter must Achieving the 7 log mentioned above, which is 99.99999%, means that less than ten million bacteria in the water-based material can pass through the filter.
Strict standards like the ASTM F838 15a test are actually a challenge for our membrane manufacturing companies. The generation and implementation of a standard is its safety compliance, so it is accepted and recognized by most of the standards. Under the premise, and our own innovation, it is the test and challenge that all our enterprises have to face.