Irvine Scientific Receives CE Mark Approval for Human Serum Albumin
Irvine Scientific has announced the receipt of CE Mark approval for its Human Serum Albumin Solution (100 mg/mL) in Normal Saline (HSA). HSA is used in assisted reproductive procedures as a protein supplement for gamete and embryo manipulation.
Irvine Scientific’s HSA is manufactured according to current Good Manufactured Practice (cGMP) guidelines and International Standards using only the highest quality, low endotoxin raw materials, in order to meet or exceed regulatory guidelines. Every lot undergoes extensive quality testing including sterility (USP <71>, CFR Title 21 part 610.12, Ph. Eur. 3.2 ), biocompatibility by Mouse Embryo Assay (MEA), to meet low endotoxin specifications (USP <85> and Ph. Eur. 2.6.14 Bacterial Endotoxins Test) as well as pH (USP <791> and Ph. Eur. 2.2.3) and Osmolality (USP <485> and Ph. Eur. 2.2.35).
“Irvine Scientific is committed to producing consistently high quality products to our customers, and to demonstrate that commitment by meeting the requirements of regulatory bodies worldwide,” said Timothy P. Mullane, Chief Operating Officer, Irvine Scientific. “We are pleased to be able to offer HSA with the CE Mark, especially for our European customers and network of distributors.”