Tim Sandle, PhD

The Problem of Biofilms and Pharmaceutical Water Systems
Friday, December 22, 2017
Biofilms are problematic to pharmaceutical water systems. If a biofilm develops then an out-of-control situation is likely to emerge. read more
Establishing a Contamination Control Strategy for Aseptic Processing
Thursday, March 16, 2017
Sterility is a key quality attribute for a class of medicines required to be sterile. The consequences of non-sterility are direct patient harm. The degree of harm is dependent upon the route of administration and the types ... read more
Removal of Endotoxin from Protein in Pharmaceutical Processes
Friday, July 29, 2016
Bacterial endotoxin is the lipopolysaccharide component of the cell wall of Gram-negative bacteria, together with other cellular material that combines to form an endotoxin complex. Endotoxin is pyrogenic and it presents ... read more
Key Criteria for the Selection of Rapid and Alternative Microbiological Methods
Saturday, April 30, 2016
Rapid microbiological method technologies aim to provide more sensitive, accurate, precise, and reproducible test results when compared with conventional, growth-based methods. Rapid methods normally involve some form of ... read more
Pharmaceutical Facility Sanitization: Best Practices Considered
Thursday, March 31, 2016
Cleanrooms and clean areas must be regularly cleaned and disinfected. This is normally undertaken using a detergent step, followed by the application of a disinfectant. It may be necessary to remove the residue of the ... read more
Current Methods and Approaches for Viral Clearance
Wednesday, September 30, 2015
Biological and biotechnological products are at risk from chemical impurities, bacteria and fungi, and from viruses. With such products the potential for transmission of viral diseases is a real risk. With viral ... read more
The Risk of Bacillus cereus to Pharmaceutical Manufacturing
Friday, November 28, 2014
A review of warning letters U.S. Food and Drug Administration indicates that contamination events associated with Bacillus species represents a relatively high proportion of microbiological related citations. During the ... read more
Variability and Test Error with the LAL Assay
Thursday, August 28, 2014
The Limulus amebocyte lysate (LAL) assay is the compendial test for the examination of bacterial endotoxin in pharmaceutical products (as described in USP chapter <85>), in-process material, and pharmaceutical grade water.... read more
Assessment of Culture Media in Pharmaceutical Microbiology
Wednesday, June 18, 2014
Culture media is of fundamental importance for most microbiological tests: to obtain pure cultures, to grow and count microbial cells, and to cultivate and select microorganisms. Without high-quality media, the possibility ... read more
A Comparative Study of Different Methods for Endotoxin Destruction
Monday, October 28, 2013
Dry heat is the established method of depyrogenation within the pharmaceutical industry. This paper describes a series of studies undertaken to determine whether successful depyrogenation can be achieved practicably using ... read more