Pharma IQ Glossary: Biological Indicators
Biological Indicators are defined as resistant microorganisms placed into or on various materials to confirm that a sterilization process is effective. Biological indicators are aquatic plant and animal life that are susceptible to specific types and levels of pollutants. They may for instance be placed within a filter in order to determine if a proposed autoclave cycle is effective. After autoclave, they are removed and culture tests are performed to see if the microorganisms were killed.
Newly Published Draft Guideline on Similar Biological Medicinal Products
May 01 by Pharma IQThe European Medicines Agency (EMA) published draft guidelines today, 2nd May 2013 on Similar Biological Medicinal Products. The guideline outlines the general principles to be applied for s...
Expert Tips in Freeze Dryer Cleaning and Validation
December 07 by Pharma IQKevin Murgatroyd, Senior Pharmaceutical Consultant and expert in the field of cleaning and validation of freeze dryers, joins Helen Winsor from Pharma IQ, to discuss lyophilisation in biologicals. Mur...
Navigating the U.S. Department of Transportation’s Regulations for Biologics and Biological Agents
April 20 by Pharma IQPharma IQ chats with Eileen Edmonson, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, about navigating the U.S. Department of Transportation’s regulations fo...
