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Irvine Scientific Receives CE Mark for HSA Solution

HSA quality adheres to cGMP guidelines and International Standards

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By: Kristin Brooks

Managing Editor, Contract Pharma

Irvine Scientific has received 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 cGMP guidelines and International Standards using quality, low endotoxin raw materials, in order to meet or exceed regulatory guidelines. Every lot undergoes extensive quality testing including sterility (USP , CFR Title 21 part 610.12, Ph. Eur. 3.2 ), biocompatibility by Mouse Embryo Assay (MEA), to meet low endotoxin specifications (USP and Ph. Eur. 2.6.14 Bacterial Endotoxins Test) as well as pH (USP and Ph. Eur. 2.2.3) and Osmolality (USP 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.”

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