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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.

Pharma IQ

The 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 similar biological medicinal products (also known as...

Contributor: Pharma IQ
05/01/2013 08:00:00 PM EDT
Pharma IQ

Kevin 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. Murgatroyd looks at the key criteria when...

Contributor: Pharma IQ
12/06/2010 07:00:00 PM EST
Pharma IQ

Pharma 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 for biologics and biological agents.

Contributor: Pharma IQ
04/19/2010 08:00:00 PM EDT