Sefar, Inc. Enhances SEFAR® PHARMA-Grade Product Line With Dedicated Manufacturing Suite
In early 2012, Sefar, Inc. (Buffalo, NY) completed the addition of a new white room, dedicated to the production of filtration, separation, and drying products for their pharmaceutical customers. Positioned next to their existing Class 10,000 cleanrooms, the new room extenuates the security and accountability of the SEFAR® PHARMA-Grade product line that includes fluid bed dryer bags, centrifuge liners, and nutsche filters.
Products produced in the manufacturing suite include those from the Sefar® PHARMA-Grade product line. Sefar® PHARMA-Grade filtration and screening solutions are the result of 180 years of experience in precision weaving and manufacturing, which are backed by an industry leading quality management program that includes ISO 9001 certification, cGMP Manufacturing Guidelines, and the exclusive SEFAR® PHARMA-Grade certification, which includes FDA compliance documentation, controlled extractable limits, and full product traceability.
The room adheres to Sefar's cGMP guidelines for pharmaceutical fabrication, consistent with their two Class 10,000 cleanrooms ISO 7 (ISO 14644-1) that create parts used in medical applications. The white room procedures follow ISO 8 (ISO 14644-1) standards. Operators are required to wear cleanroom attire, including hair nets, gowns, and cleanroom booties. All equipment is thoroughly sanitized before each production run. The new room is equipped with state of the art sewing machines, used to fabricate products.
The introduction of this new white room will provide a number of benefits to Sefar customers, with accountability leading the way. "Sefar is the only supplier that manufacturers the yarn, weaves the filter fabric, and fabricates the end use part. We can control the quality level at all steps within the manufacturing product," according to Sefar Market Manager Mike Branson. Vice President of Sales, Bob Hamilton adds "no other filter or bag supplier to the pharmaceutical industry has this level of accountability." Branson points out, "We made this investment because this market requires top end supply of their parts – especially cleanliness of the cloth."
To learn more about Sefar or SEFAR® PHARMA-Grade products, visit www.sefar.us.
SOURCE: Sefar, Inc.