Biopharmaceutical facility cleaning validation using the total organic carbon test

The total organic carbon (TOC) test is a fast and effective analytical technique to evaluate the cleaning of biopharmaceutical manufacturing equipment. This technique can help ensure that the cleaning processes meet predetermined cleanability criteria for single and multiproduct production areas. Th...

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Veröffentlicht in:	Biopharm International 2010-06, Vol.23 (6), p.36
Hauptverfasser:	Garcia, Julio Cesar Sanchez, Echagarruga, Raudel Sosa, Sanchez, Meily, Albarran, Rebeca Bouyon, Hernandez, Luciano, Alfonso, Marbel Ramos, Lasa, Alexis Musacchio, de la Fuente, Leopoldo Nunez
Format:	Magazinearticle
Sprache:	eng
Schlagworte:	Accuracy Bacteria Biological response modifiers Carbon Case studies Cell research Discount coupons E coli Epidermal growth factor Genetic engineering Good Manufacturing Practice Interferon Manufacturing Methods Microbiology Microorganisms Oxidation Phosphoric acid Proteins Recombinant proteins Soap and cleaning agents industry Standard deviation Sucrose Yeast
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Beschreibung
Zusammenfassung:	The total organic carbon (TOC) test is a fast and effective analytical technique to evaluate the cleaning of biopharmaceutical manufacturing equipment. This technique can help ensure that the cleaning processes meet predetermined cleanability criteria for single and multiproduct production areas. This article presents a case study describing the use of the TOC test to validate the cleaning processes used for two types of biomanufacturing equipment. [PUBLICATION ABSTRACT]
ISSN:	1542-166X 1939-1862