Pharmig

Microbiology for Non-Microbiologists – IRELAND

March (date & venue & Fees TBC)

What is it?

The ‘Microbiology for Non-microbiologists’ course is a 1-day theoretical training course that will help you to understand the fundamentals of microbiology and its importance in pharmaceutical manufacturing. The course focuses on what microbiology is and why it is important, the impact of contamination on the product/process, understanding the risk to the patient from contaminated products, and typical controls for preventing microbial contamination.

Who should attend

This course is intended for people with no previous knowledge or experience of microbiology, such as those working in QA, production, engineering, regulatory compliance, validation, development etc.

AGENDA

08.45 – 09.00Tea/Coffee & Registration
09.00 – 09.30Introduction & Welcome
09.30 – 10.35An Introduction to Microbes (Andy Martin)
An overview of the different forms of microbial life – bacteria, moulds, yeasts, viruses, and prions

  • Gram positive and Gram-negative bacteria
  • Bacterial and fungal spores
  • Growth requirements for bacteria, yeast and moulds
  • Growth requirements for viruses
  • How microbes impact our daily life – the “good, the bad, and the ugly”
10.35 – 11.25Microbes as Pharmaceutical Products

  • Fermentation
  • Antibiotics
  • Bacterial and viral vaccines
  • Biopharmaceuticals
11.25 – 11.40Coffee Break
11.40 – 13.00Sources of Microbial Contamination & Contamination Control
Sources of microbial contamination in the pharmaceutical setting – their significance and control

  • Human commensal organisms – personal hygiene and gowning controls
  • Environmental organisms – cleaning and disinfection programmes, environmental monitoring
  • Raw materials – sourcing and monitoring controls
  • Pharmaceutical utilities – generation and monitoring controls for water and process gases
  • Examples and case studies of pharmaceutically significant microbes
13.00 – 13.45Lunch
13.45 – 15.00Manufacturing Processes for Contamination Control
Methods for preventing contamination of the product and production environment

  • Product risk profiles
  • Developing robust product formulations
  • Manufacturing process controls
  • Hygienic design of facilities and equipment
  • Sampling and aseptic technique
  • HTST pasteurisation
  • Manufacture of sterile products
    • The concepts of sterility and sterility assurance
    • Aseptic processing vs. terminal sterilisation
    • Sterilisation methods
    • Aseptic process simulations
  • Viral inactivation
15.00 – 15.15Coffee Break
15.15 – 16.15Detection of Microorganisms

  • The colony forming unit
  • Microbiological testing of pharmaceutical products
    • Microbial limits testing
    • Tests for specified organisms
    • Objectionable organisms
    • The sterility test
    • Endotoxin testing
    • Antimicrobial effectiveness testing
  • Microbial identification
  • Data interpretation & misinterpretation
  • Microbial out of specification results
16.15 – 16.45Interactive Exercise
Working in small groups, delegates will be given details of a typical pharmaceutical process and asked to identify critical control and monitoring points for the prevention of microbial contamination.
16.45 – 17.00Closing remarks, open Q&A

To register your interest please click here maxine@pharmig.org.uk

Additional information

Date