What Makes An Objectionable Organism in 2020?


I wrote the first version of this article in 2014 based on training I developed in 2006.   I have updated and reviewed the content to ensure it remains relevant in 2020.

When testing non sterile products, as well as allowed numbers of microbes, there are certain types of microbes that are specified in the regulations as not allowed and still others that can de deemed to be objectionable.

If you work as a microbiologist where you test total microbial aerobic counts (TMAC), total yeast and mould counts (TMYC) and for specific microbes or conduct investigations into the nature of microbes and what impact they may have on the product and the end user, this presentation will benefit you. I will teach you the the following:

  • What makes a specified organism
  • What makes an objectionable organism
  • How to determine if a microbe is objectionable
  • Risk assessment considerations
  • The benefits of knowing the differences between specified & objectionable organisms

Continue reading

About 20% of (FDA) Recalls are Due to Microbial Contamination.

As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of  sterility assurance.  Another 27 were due to impurities with 5 more due to mislabeling.  Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination.

It is vitally important that your products are fit for purpose. What is on the label must be in the product. Nothing more. Nothing less. Quality assurance goes a long way and with the correct processes in place, the number of potential batch recalls should be zero.

With regards to microbial contamination, I am updating my “Microbiology for Non-Microbiologists” presentation and will shortly be providing an abridged version online. Stay tuned.

Developing My Writing While Helping Others

I am a microbiologist with over 15 years’ experience in the pharmaceutical realm. I have a strong interest in regulatory compliance and developing others. Recently I have been working closely with data security. I have an arty streak, have been a work place trainer and have an affinity for computers.

Lately I’ve been thinking of ways to share my knowledge with others outside of my cycling and science blogs and have decided to write 12 LinkedIn posts over 12 months. I will limit the post size to between 500 and 1000 words (1-2 A4 pages). Continue reading


Quality Assurance – How to Apply Scientific Principles to Troubleshooting

My work called for presenters on a wide range of topics, both work and non work related. I put my hand up to deliver a talk on something drawn from my background as a scientist. After some thinking I came up with “Quality Assurance – How to Apply Scientific Principles to Troubleshooting”. I thought that would be a good topic as that’s the main thing I do in my current role and I did a lot of it in my old roles. I thought I would be able to impart knowledge to help others examine and solve their problems. Project mangers might find it useful. Software developers might find it useful. Athletes might find it useful.

Feedback from this session was positive.

Quality Assurance – How to apply scientific principles

I developed this into my first LinkedIn Article on 11th April 2019.

Presentation Recording (new and improved – May 2020)

Presentation Recording (original – audio is bad)

You could watch a little of this to see how I improved the presentation.

Policy vs Standard Operating Proceedure vs Operator Instruction

What follows will form part of a post tentatively titled “GMP Technical Writing”. The larger post will incorporate aspects of Writing Technical Reports and The Need for Documentation and detail the hierarchy of documents within a Quality Management System, what information goes where and how to conduct buisiness process mapping. I’m tossing up on whether to present this as a series of posts or as some sort of presentation style document (pdf or Powerpoint).

A Policy A SOP An OI
What’s What  Course of action adopted due to one or more considerations such as legal or regulatory requirements

Contains regulatory, corporate or scientific policies, rules or principles.  Explains why these are considerations.

generally affect multiple SOPs.  If affects one SOP, should include detail in SOP after Additional Information section.

  • If information >1 page and affects >1 SOP
  • or >3 pages and affects 1 SOP, write a separate policy document
  • Who, what, when where and why.
  • A series of stages describing the sequence of tasks performed
  • Describes processes lasting an extended time (hours, days, weeks).
  • Tends to encompass multiple users.
  • Written with the overall goal of achieving the outcome via a number of specified outcomes.

Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:

  • ≤4 steps -SOP content.
  • >4 steps – place in an OI.
  • How to do something.
  • Step wise instructions.
  • Takes place in the now.
  • Tends to involve single user.
  • Written to achieve a specified outcome.
Tables  Informational
  • Overview only – Section/Description.
  • Stage/Description.
Flow Charts  Informational

Must not exceed 1 page.

Used a process overview.

  • If ≥5 sections, a flow chart can be used.
  • If <5 sections, a Section/Description table use used.
  • Must not exceed 1 page.
  • Suitable only where instructions are straightforward.
  • Must not exceed 1 page.
Naming Convention  N/A Use present continuous. eg. Sampling of Water for Injection
!!”ing” in the title.
Use the present simple. Daily Check of Equipment Calibration
!!If the proposed title includes “How to…” the it’s likely an OI.
In General
  • Section headings do not include full stops
  • For all nouns and verbs in document titles, use capitals. Does not apply to section headings.

-Title: Using The Autoclave
-Section Heading: Load the autoclave

  • Be consistent in the use of bullets and font.
  • Be consistent with capitalisation and use of punctuation.
  • Read your work out loud. If you stumble, the reader will too.
  • Plan. Talk to SME’s. Before you begin writing, identify the information type(s).
  • Chunk the information 7±2

Autoclave Validation

Updated June 2020:

With the age of my presentation and the recent PE009-14 update it was high time to review and update my Autoclave Validation training/presentation.

The linked to pdf contains Autoclave Validation training I have presented in person and via teleconference.

The purpose of the training is as follows:

  • What is an autoclave
  • Why we use autoclaves
  • Identify the two main types used by us
  • Detail how to validate an autoclave (including loading patterns)
  • What to look for in an audit

It is important to note that this training was developed in 2008.  Some references may be out of date.  The overall thinking and methodology remains valid.

Autoclave Validation Presented by Paul Yeatman Bsc – 2020 (pdf)

Autoclave Validation – 2006 version (pdf).

Additional Autoclave Validation Documentation


Microbiology For Non Microbiolgists

I have experience developing training and presenting it to small to medium sized groups. Part of this process involves determining the way in which to present the training. Once such way to use some form of visuals in support of speaking. For my Microbiology for Non Microbiologists course, I used Microsoft Powerpoint.

Duration of Session:

  • 60 minutes x1, followed by 10 minutes x1 (display style)
  • Number of attendees: 5-10

Continue reading

Antibiotic Assays

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

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