STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its new Filter Testing Services for pharmaceutical and medical device manufacturers. These services are designed to help manufacturers ensure the safety and efficacy of their products by verifying the performance of filters used in the manufacturing process.
Filtration sterilization is an important unit operation in the aseptic manufacturing process. It requires proper process validation to verify the performance of the filters used for sterilization filtration. Filter testing is used to evaluate a filter’s ability to separate microorganisms of various sizes and helps manufacturers determine membrane pore size. This test is also an excellent batch release test. Test data can also be used as an effective marketing tool.
STEMart provides comprehensive facility and process validation for medical devices. With extensive expertise in Filter Testing, STEMart can provide a full service experience to assist manufacturers in meeting regulatory goals and minimizing compliance risks. The comprehensive Filter Testing services are guided by “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice”, the FDA guidance document for industry, which outlines the general considerations the FDA believes should be taken into account when performing filter testing for a medical device.
STEMart offers a wide range of Filter Testing services. For example, Retention Capacity and Filtration Efficiency Test demonstrates the filter’s ability to remove all bacteria from a liquid bacterial suspension under specified conditions according to ASTM 838-05. Validation of the filtration process takes into account all factors that may affect the performance of the filter, such as pH, viscosity and compatibility of the material being filtered with the filter, flow rate, pressure, temperature, and hydraulic shock.
Filter Extractables Test identifies and quantifies compounds that have the potential to become leachables. Suitability Test verifies that the filter meets all requirements under product and process conditions, including, but not limited to, resistance to high temperatures, resistance to fatigue under pressure and flow changes, and resistance to high pressure changes.
Based on ISO 10992 and ISO 18562 standards, FDA guidelines, ASTM (American Society for Testing and Materials) standards and other international guidelines, STEMart’s experts have many years of experience in a wide range of testing services for Class I, II and III medical devices and can help clients ensure that every aspect of the medical device is properly tested.
If you have additional questions about Filter Testing or would like to find out more about Medical Device Testing services, please visit https://www.ste-mart.com/filter-testing.htm.
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.