Synder Filtration Meets USP Class VI Certification Requirements in the Pharmaceutical Industry

Posted on January 15, 2014

Filtration methods are employed to accomplish a variety of initiatives in the modern pharmaceutical and biotechnology industries. Synder Filtration offers polymeric flat sheet membranes and spiral wound membrane elements that may be implemented, for example, to concentrate enzymes, process antibiotics, and remove harmful organisms such as microbes, endotoxins, and bacteria from a substance. Depending on the specific application, Synder membrane products may be required to meet certain industry standards to ensure that the substances being filtered are not negatively affected by the materials used in the separation processes.

In 2012, Synder Filtration was approached by a large international pharmaceutical company seeking a substitute for the spiral wound ultrafiltration membranes it was using. Synder was asked to create an element functionally equivalent or superior to the product from the existing supplier. This meant that the new element was required to not only physically fit the same dimensions and feature comparable or improved separation capabilities, but to also meet the pharmaceutical industry standards for human safety in order to be used in a drug manufacturing process.

Working closely with the pharmaceutical company, Synder was able to design, develop, and commercialize an element that met their specifications, and through testing by an independent laboratory, this product was reported to meet the requirements for the U.S. Pharmacopeial Convention’s (USP) Class VI plastics on July 1, 2013.

As a result of this effort, Synder is now able to offer a family of ultrafiltration elements that meet the USP Class VI certification requirements, meaning that these products did not have any damaging impact on a sample of living tissue in tests of biocompatibility and are therefore safe for use in pharmaceutical production. These sanitary-style, spiral wound elements feature polyethersulfone (PES) membranes with molecular weight cut-offs ranging from 1,000 to 300,000 Dalton. In addition to the USP Class VI compliance certification, elements can be highly customized and also sanitized in hot water, with high pH and temperature resistance.

Contact Synder Filtration today to learn more about the elements available for the pharmaceutical and biotechnology industries, or to find out how a unique solution can be created to meet your process separation needs – your inquiry will always receive a personal response within 24 hours. You can also visit the News section at www.synderfiltration.com to stay up to date on all of Synder’s industry-leading innovations.