Author Archives: P Yeatman

The Validation Master Plan

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I was recently asked where I would start if I was tasked with developing the Validation Master Plan or VMP for a microbiology laboratory.

That got me thinking. I’ve done my share of validations over the years, encompassing such things as viable particle air samplers, large format incubators, temperature mapping, autoclave validation, sterile media trials, computer system validation and various microbiological test methods. I’ve also written validation documentation in the form of user requirement specifications (URS), installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ) as well as the validation protocols and reports. To take on the task of developing the master plan would be challenging and to my mind, an exciting and fun/rewarding project. I love documentation! Continue reading →

How do we deal with strange theories?

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The Question posed on LinkedIn.

“I’ve been seeing a lot of this study the past couple days, there are a couple things bothering me in the coverage. First, I realize the point of the study was to show that most of the fat being burned is exhaled. However, this is somewhat a simplification and sort of gives the impression that the body is a bomb calorimeter (which is one aspect of many fitness/nutrition articles that bothers me anyway). I guess I would’ve personally addressed that in the explanation had I been the one to write it. Second, and more troubling to me, an unintended consequence of the way that this is covered means that many people are taking this to mean that hyperventilating or taking more oxygen in means that they will exhale more carbon dioxide and therefore lose weight without activity or diet changes. The second point is one I would have never thought to address in writing the article, so it’s made me wonder how far we have to go to address ‘strange unscientific theories’ that will pop up as a consequence of explaining research to those who aren’t as scientifically literate.”

My comment/advice:

Unscientific? Strange? The biochem knowledge seems stable (I learned the same thing in the early ’90’s with regards to carbon dioxide and water). Nothing strange about the metabolic pathways.

The paragraph about hyperventilation said do not do it and in no way advocates it. If the conclusion was to breathe more and pass out causing you to not eat as much, that would have been poor advice and potentially unscientific (passing out vs metabolic rate changes and so forth).

What makes science newsworthy?

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The Question posed on LinkedIn.

“What makes science newsworthy?”

My comment:

For specialists: a new discovery or confirmed hypothesis. Eg inflation marker, fine details of element 117.

For the couch scientist & inquiring minds: anything written well enough to be interesting.
Eg practical uses of graphene, quantum mechanics, “Cosmos”, Neanderthals vs Cromags.

For the non scientist: discoveries and developments that have the potential to affect them directly. Eg faster car, climate change, room temp super conductors, fusion power.

Career Advice

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The Question sent via LinkedIn.

” I am a Microbiologist with 3 years overseas experience. I have completed Bachelor degree in Microbiology and a Post-Graduate Degree in Medical Microbiology. I am finding it difficult to be considered for an interview since I have only overseas experience. I have recently undertaken a Post graduate Single course in Medical Microbiology from RMIT University, Melbourne to update my skills in this area and is currently looking for a job opportunity / work experience in Microbiology and would like to know if you could provide any support / advise in this regard.”

My advice:

I can only provide advice at present as I’m an unemployed microbiologist at present also. With regards to micro roles, you could see if the job agencies can help (in my experience they cannot). You could determine who has the sort of micro positions you are interested in and send the an old fashioned canvassing letter. My first micro job came from one of those and once your foot is in the door, things get easer. When applying for roles, relate your skills and experience to the roles you are applying for.

When Experts Get It Wrong

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I’ve had a post about bacteriology and mycology in the works for sometime, but as I’ve yet to finish it off here’s a link to a study titled The paradox of human expertise: why experts get it wrong. I generally defer to the experts as they are the experts. Sometimes, the status quo is incorrect and people new to the scene or uneducated in what the current thinking is come up with radical ideas that are later shown to be vidicated. So in honour of those times when those not in the know are actually ahead of the curve, here’s the link: The paradox of human expertise: why experts get it wrong.

One of the true measures of an expert is they will admit when they get things wrong or do not know the answer.

Here’s a local version.

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Antibiotic Assays

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A brief history of the antibiotic assay

The quantitative use of zones of agar made inhibitory to the growth of one microorganisms by diffusing substances produced by another organism was in use at least as early as 1885 (Analytical Microbiology, Kavanagh, 1963). The first official assays of penicillin were carried out in 1943. Publication of the theoretical aspects involved was published by Cooper and Woodman in 1946 in Pathological Bacteriology. The antibiotic assay used by pharmaceutical companies is primarily the agar plate diffusion assay. Some products that are a mixture of polymers may have a specific monograph stating that they must be assayed by a turbidimetric method. Such an example is Gramicidin. Continue reading →

Writing Technical Reports

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What is technical writing?

Technical writing is a style of writing used when preparing protocols, reports, investigations and other laboratory documentation.

What are some examples of technical documents?

In general, any regulated manufacturing site will use the following technical documents: validation documents, reports, Standard (Operating) Procedures, SOP’s and Work/Operator Instructions (OI’s), standard forms and overriding policies and a Site Quality Manual all within the framework of a Quality Management System (QMS), Continue reading →

The Importance of Trending

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What is Trending?

Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading →

Viable Environmental Monitoring

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This was repurposed into a LinkedIn article as part of my Developing My Writing While Helping Others series.

What Is Viable Environmental Monitoring (VEM)?

Viable Environmental Monitoring (VEM) is the monitoring of factors within a production environment that may have an impact on the quality of goods produced within the environment. Typically this is any physical object than could support or introduce microbial contamination to a manufacturing environment: air, gases, surfaces (both on introduced objects and within the production room), liquids and people.  This discussion does not extend to Environmental Monitoring such as particle counting, temperature, pressure differentials, etc. Continue reading →