Part of my Life in the Lab Series.
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Analyst, what does the day entail? Continue reading
Drawing from over 20 years of industry experience, gain valuable insights and expert perspectives from a trusted microbiology quality assurance leader and internal auditor.
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Analyst, what does the day entail? Continue reading
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Technician, what does the day entail? Continue reading
The TMC is broken into two parts: a basic look for contamination and a look for more specific forms of contamination. The basic test is described in the USP in section <61> or in the EP in section 2.6.12. The more specific or specified microbe testing is described in USP section <62> or in the EP in section 2.6.13. Continue reading
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
This was repurposed into a LinkedIn article as part of my Developing My Writing While Helping Others series.
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