Author Archives: P Yeatman

Approaches to trend analysis of micro monitoring during aseptic processing?

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The Question posed on LinkedIn.

“Companies are expected to perform trending of their monitoring data. Detecting adverse trends should help to prevent exceedings of regulatory limits, as defined e.g. in Annex 1 to the EU or PIC/S GMP Guide for aseptic operations.

As you all know, microbial counts do not follow a normal Gaussian but a logarithmic distribution, such that the classical way of calculating and defining thresholds for alert (often +/- 2s) and action (+/- 3s) cannot be applied.

Hence, what alternative approaches to setting alert and action limits for microbio monitoring data (environment, staff, water, …) do you apply?”

My advice:

You need to have defined what your alert and action levels are and how many times in a row a site can be in alert before this constitutes an action. You also need to define how many below alert results may indicate an adverse trend.

Basically you want to get what is heading out of control under control.

You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.

Your internal process and documents will be dependant on which regulatory bodies have oversight at your facility.

The FDA, PDA, PIC(S), ICH and good resources like the PMF are valuable when developing your internal processes.

Some resources:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm124900.htm

http://www.microbiologyforum.org/content/file/PMFNews.17.03.1103.pdf

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/midwest/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4

Patties Foods Frozen Berries

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I reply to a post on LinkedIn.

“The Patties Foods frozen berries scandal is a warning for directors about managing risks – what lessons could you learn? ”

My comment:

There’s lots of testing for bacterial contamination in such products as it’s regulated at Government level. Testing for viruses is not a routine requirement (it is not regulated). There’s been discussions on changing this as reportedly, about 20% of food contamination is caused by viruses and it might be a good idea to start testing.

No Current Experience – Catch 22 In Job Seeking

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Updated 20/06/2020

June 2020: Yet another “failed” job interview where I was passed over as “we went with someone with recent experience who can hit the ground running”.

Introduction

  • My last microbiology/science role was made redundant by my employer towards the end of 2012.
  • I’ve been trying to get back into a microbiology lab, QA department or related area ever since with zero success.
  • I stay active in science by reviewing regulatory updates and championing science via social media and by providing advice on LinkedIn, posting articles to share my experiences and producing online training presentations.

Continue reading →

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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