Tim Sandle, PhD

Microbial Considerations for the Selection of Aseptic Connectors
Monday, April 19, 2021
The application of single-use, sterile and disposable technology is encouraged by regulators, as the draft to EU GMP Annex 1 indicates. Such technology can increase the level of sterility assurance and reduce the ... read more
Mycological Assessment of Pharmaceutical Grade Raw Materials
Tuesday, March 16, 2021
It has been estimated that around half of the fungi found in the environment could cause infections in people (mycosis). For this reason, mycoremediation remains an essential part of any pharmaceutical manufacturer’s ... read more
Still Moving Forwards: Recent Advances with Rapid Microbiological Methods
Wednesday, February 17, 2021
Rapid microbiological methods continue to advance, with novel technologies appearing on the marketplace albeit more orientated towards general research or to the food quality sector rather than conventional pharmaceutical ... read more
Historical Milestones and Industry Drivers in the Development of Recombinant Lysate for Bacterial Endotoxin Testing
Monday, October 05, 2020
Parenteral pharmaceutical products, ingredient water, and some constituent materials undergo bacterial endotoxin testing since endotoxins are pyrogenic in humans and above a threshold this can induce severe physiological ... read more
Effectivity of HEPA Filters to Remove Viruses from Air Entering Cleanrooms
Monday, June 22, 2020
In the manufacture of certain pharmaceuticals, viral removal or destruction is a key part of manufacturing (such as products produced from cell lines or from blood or plasma, as per ICH Q5A). This requires a combination of ... read more
Minimizing Microbial Survival of Cleanroom Surfaces
Tuesday, March 24, 2020
Microbial monitoring in cleanrooms is generally performed using standard, cultivation dependent approaches based on the usage of contact plates or swabs. It is well-established that environmental monitoring methods are ... read more
Endotoxin Testing as a Detection Method for Bacterial Biofilms
Friday, November 08, 2019
Microbial biofilms - structured consortium of bacteria that are embedded in layers of self-produced polymer matrices, largely composed of polysaccharide, protein and DNA – are well described and known problems for ... read more
Multidrug Antimicrobial Resistance Testing and Fecal Transplant Therapy Risks
Friday, October 11, 2019
Following the death of one patient and another falling seriously ill (reported in June 2019), the U.S. Food and Drug Administration (FDA) has called for greater controls over fecal transplants and the introduction of ... read more
Focusing on the Operator: Reducing Facility Environmental Contamination
Tuesday, April 23, 2019
The majority of contamination in a pharmaceutical facility, presuming that the air handling system is functioning as designed, that water systems are low in bioburden and are not leaking, and there is good control of in-... read more
Applying Data Integrity Principles to the Cleanroom
Thursday, March 21, 2019
Data integrity relates to any type of ‘data’, and the degree to which a collection of data is complete, consistent, and accurate. Data can exist in a variety of forms – as numbers or text on paper or as bits and bytes in ... read more

Tim Sandle, PhD

Articles by Tim Sandle, PhD

Microbial Considerations for the Selection of Aseptic Connectors

Mycological Assessment of Pharmaceutical Grade Raw Materials

Still Moving Forwards: Recent Advances with Rapid Microbiological Methods

Historical Milestones and Industry Drivers in the Development of Recombinant Lysate for Bacterial Endotoxin Testing

Effectivity of HEPA Filters to Remove Viruses from Air Entering Cleanrooms

Minimizing Microbial Survival of Cleanroom Surfaces

Endotoxin Testing as a Detection Method for Bacterial Biofilms

Multidrug Antimicrobial Resistance Testing and Fecal Transplant Therapy Risks

Focusing on the Operator: Reducing Facility Environmental Contamination

Applying Data Integrity Principles to the Cleanroom

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