MicrobeWorld explores the world of microbes with vivid images and descriptions. The magazine recently interviewed Tim Sandle about his career, inspirations and the latest developments in microbiology.
Here is an excerpt:
Q) Moving little ahead of your work. You have an experience of pharmaceutical microbiology risk assessment and investigation. Will you please elaborate your work as a risk investigator? How much you feel that risk investigation in the microbiological field is important in this modern world?
Tim Sandle: Risk assessment is of great importance and it is one of the key developments with pharmaceuticals in the past decade. In the past, the focus was on quality control and the idea of simply testing products and environments. This either meant that there was an attempt to 'test into compliance' or that the wrong things were being tested for. The approach also failed to consider how to stop risks from re-occurring.
The new risk management approach is more proactive. It involves looking
at processes and considering where microbial contamination is likely to
occur. Following this, the severity of the risk is considered, in
relation to the environment and to patient harm. Attempts are then made
to eliminate or to mitigate the risk. Only after all this has been
completed is the monitoring plan decided, and here the objective of the
plan is to see how effective the risk mitigation measures have been.
Applying risk assessment involves using tools like HACCP (Hazard Analysis Critical Control Points), which requires the process to be mapped; and FMEA (Failure Modes and Effects Analysis), which is particularly useful for equipment. For example, if you are concerned about the operation of an autoclave and its ability to effectively sterilize an item then FMEA can be a powerful tool.
Aside from machinery and environments, risk assessment is useful for considering the microbial risk to medicines. Where microorganisms are detected, knowing the species, the numbers and the toxins each helps to consider the risk to the patient. There is a body of work around the subject of Quantitative Microbiological Risk Assessment (QMRA), which is very useful. QMRA is the process of estimating the risk from exposure to microorganisms by combining dose response information for the infectious agent with information on the distribution of exposures.
There are four very distinct steps in the risk assessment process. The
first step is hazard identification, which involves the collection,
organization, and evaluation of all information pertaining to a pathogen
or a nutrient. Second is hazard characterization, which determines the
relationship between a pathogen and any adverse effects. Third is
exposure assessment, which involves determining how much of pathogen
might be ingested in a serving of food. The fourth, and last step, is
risk characterization, which involves evaluating the risk and related
information.
The interview can be accessed here: MicrobeWorld
Posted by Tim Sandle
Here is an excerpt:
Q) Moving little ahead of your work. You have an experience of pharmaceutical microbiology risk assessment and investigation. Will you please elaborate your work as a risk investigator? How much you feel that risk investigation in the microbiological field is important in this modern world?
Tim Sandle: Risk assessment is of great importance and it is one of the key developments with pharmaceuticals in the past decade. In the past, the focus was on quality control and the idea of simply testing products and environments. This either meant that there was an attempt to 'test into compliance' or that the wrong things were being tested for. The approach also failed to consider how to stop risks from re-occurring.
The new risk management approach is more proactive. It involves looking
at processes and considering where microbial contamination is likely to
occur. Following this, the severity of the risk is considered, in
relation to the environment and to patient harm. Attempts are then made
to eliminate or to mitigate the risk. Only after all this has been
completed is the monitoring plan decided, and here the objective of the
plan is to see how effective the risk mitigation measures have been.Applying risk assessment involves using tools like HACCP (Hazard Analysis Critical Control Points), which requires the process to be mapped; and FMEA (Failure Modes and Effects Analysis), which is particularly useful for equipment. For example, if you are concerned about the operation of an autoclave and its ability to effectively sterilize an item then FMEA can be a powerful tool.
Aside from machinery and environments, risk assessment is useful for considering the microbial risk to medicines. Where microorganisms are detected, knowing the species, the numbers and the toxins each helps to consider the risk to the patient. There is a body of work around the subject of Quantitative Microbiological Risk Assessment (QMRA), which is very useful. QMRA is the process of estimating the risk from exposure to microorganisms by combining dose response information for the infectious agent with information on the distribution of exposures.
There are four very distinct steps in the risk assessment process. The
first step is hazard identification, which involves the collection,
organization, and evaluation of all information pertaining to a pathogen
or a nutrient. Second is hazard characterization, which determines the
relationship between a pathogen and any adverse effects. Third is
exposure assessment, which involves determining how much of pathogen
might be ingested in a serving of food. The fourth, and last step, is
risk characterization, which involves evaluating the risk and related
information.The interview can be accessed here: MicrobeWorld
Posted by Tim Sandle
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