Life in the Lab – Microbiology Team Leader

Part of my Life in the Lab Series.

Here I summarise what each of my scientific roles have entailed.

As a Microbiology Team Leader (non sterile laboratory), what does the day entail?

08:30 hrs – Start shift

  • Check how everyone is going today
  • Determine what needs to be done in next two months and delegate
  • Spot check equipment calibration labels
  • Conduct sampling of Purified Water system if short staffed
  • Followup with other departments regarding on going projects
  • Update documentation or delegate and meet with subject matter experts
  • Check and signoff on environmental monitoring data (worksheets) or delegate
  • Ensure any followup sampling has been completed, if not find out why and reschedule
  • Interview prospective staff

10:30hrs – 15 minute break

  • Check how everyone is going
  • Validation and introduction of equipment such as dust containment hoods and flammable liquid containers
  • After developing, deliver special training to production, eg Microbiology for non-microbiologists
  • Conduct antibiotic potency testing if short staffed (also method trouble shooting)
  • Read and record viable environmental monitoring results if short staffed
  • Train staff in sampling techniques or delegate
  • Pursue special projects or delegate
  • Sign off on environmental monitoring data
  • Delegate the testing of “urgent samples” and manage expectations of requestor
  • Meet with product representatives
  • Schedule and chair regional meeting of microbiologists as part of information sharing and method harmonisation
  • Conduct performance reviews of team

12:30hrs – 45 minute lunch

  • Check how everyone is going
  • Schedule or delegate external testing
  • Review the regulations for gaps and improvements
  • Formulate media if short staffed
  • Meeting with production managers, supervisor and filling room staff as part of out of specification results investigation
  • Write investigation reports
  • Deliver training to team (routine and special)
  • Conduct investigative monitoring or delegate
  • Investigate and report on environmental monitoring trends

15:30hrs – 15 minute break

  • Check how everyone is going
  • Attend site consolidation project meetings
  • Conduct internal audit (about every 6 months based on schedule)
  • Ensure OH&S is being followed (this is a constant thing every time I enter then lab)
  • Continue tasks from earlier in the day
  • Contribute to yearly budget
  • Catch up meeting with lab manager
  • Travel to other company sites in same city for meetings
  • Examine training status of team and schedule training / update records
  • Issue updated documentation and train staff if training required
  • Determine if tasks scheduled for tomorrow
  • Determine if there is anything that needs the later afternoon shift or night shift to be aware of

17:00 – Depart for home

Roles Held

Microbiology TechnicianMicrobiology AnalystSenior Microbiologist aka “Microbiology Officer”Quality Assurance Microbiologist – Non Sterile Microbiology Team Leader

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

Viable Environmental Monitoring

What Is Viable Environmental Monitoring (VEM)?

Viable environmental monitoring 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, surfaces (as in introduced equipment), liquids, people.

Why Is VEM Needed?

Microbial monitoring is used to determine if the controlled environmental being monitored is within an adequate state of microbiological control (i.e whether or not the area meets the specifications as described in the site quality manual, product registration dossiers and associated documents) . It may also be used to confirm that cleaning and sanitation is effective (and being conducted as specified) and that personnel within the production environment are not carrying an unacceptable bioload or inadvertently causing contamination. This is required information as it ensures that products produced are unadulterated and are fit for their intended purpose. Continue reading