The Characteristics of Microorganisms
- Cellular organisation, function
- Products, toxins, endotoxins, antibiotics, enzymes
- How it occurs
- What is required for growth?
- Growth kinetics – laboratory culture versus nature
- Effect of stress factors on growth
Microbial Identification Techniques
- What is the significance of a name?
- Distribution of microorganisms in nature, raw materials and water
- Distribution of microorganisms in pharmaceutical facilities
Detection Methods and their Limitations
- What can be detected by:
- The sterility test
- The bioburden test in its various forms. Membrane filtration, pour plate, spread plate, MPN
- The test for specified organisms
- The endotoxin test
- Limits of detection and factors effecting limits of detection
- Validation of Microbial Test Methods
- Basic principles of validating a microbial test system
- What approaches can you take when a microbial assay test cannot be validated?
Cleaning, Sanitation, Disinfection
- Why cleaning before disinfection?
- The difference between cleaning and disinfection
- Disinfectants and their efficacy
- Methods of disinfection
- Disinfection validation
- Sampling techniques
- air sampling
- settle plates
- Technical limitations and interpretation of results
- Is there a relationship between high results and contaminated product?
How to Handle Microbiological OOS Results
- Typical Out-Of-Specification results
- Sterility testing
- Endotoxin testing
- Cleanroom monitoring
- Investigation of Causal Connection
- Laboratory failure investigations
- Sampling/process/production failure investigation
- Type of microorganisms
- Deviation/investigation report
- Calculation of mean values
- Principles and kinetics of sterilisation
- Selection of sterilisation method
- Types of sterilisation methods
- Validation of the sterilisation process
The objective of these workshop sessions is to give the participants some hands on experience with the fundamentals of microbial techniques and the difficulties associated with interpretation. They will also provide the chance to discuss common problems in an informal atmosphere.
Workshop 1: Hygienic Deviations
Participants will work in small groups on practical case studies of microbiological deviations. They will work
on a root cause analysis and defining corrective and preventive actions.
Trouble shooting in the microbiological laboratory.
The focus will be on those problems that occur frequently in microbiological quality control. Practicable solution to these challenges will be discussed in small groups.