The Characteristics of Microorganisms
- Fungi
- Bacteria
- Mycoplasma
- Viruses
- Cellular organisation, function
- Products, toxins, endotoxins, antibiotics, enzymes
Microbial Growth
- 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
Microbiological Methods: Suitability Test vs. Method Validation
The difference between a Method Suitability Test (MST) and a Method Validation will be explained using selected examples:
- The practical realization of a MST of a Microbial Enumeration Test (Ph.Eu. 2.6.12 / USP <61>) and a Sterility Test (Ph.Eu. 2.6.1/ USP <71>) is presented
- The Method Validation of a Rapid Sterility Test according to Ph.Eu. 5.1.6 / TR33 / USP <1223> is shown
Cleaning, Sanitation, Disinfection
- Why cleaning before disinfection?
- The difference between cleaning and disinfection
- Disinfectants and their efficacy
- Methods of disinfection
- Disinfection validation
Environmental Monitoring
- Sampling techniques
- Air sampling
- Surfaces
- Settle plates
- Technical limitations and interpretation of results
- Is there a relationship between high results and contaminated product?
Case Studies on Monitoring and Hygienic Deviations
Pharmaceutical Water - Microbiological Control and Deviation Management
- Regulatory requirements
- Warning and action Limits
- Measures to be taken when warning and action Limits are exceeded
- Repeated non-conforming results
- Examples of warning and action limit exceedance
- Source of microbial contamination, biofilms
Sterilisation Methods
- Principles and kinetics of sterilisation
- Selection of sterilisation method
- Types of sterilisation methods
- Validation of the sterilisation process
How to Handle Microbiological OOS Results
- Typical Out-Of-Specification results
- Sterility testing | Bioburden | Endotoxin testing
- Cleanroom monitoring - Investigation of causal Connection
- Laboratory failure investigations
- Sampling/process/production failure Investigation
- Type of microorganisms
- Deviations/incidents/assessment
- Deviation/investigation report - Retesting/Reanalysis/Resampling
- Definitions
- Calculation of mean values
- Rejection/Release
Trouble Shooting - Examples and Case Studies Sessions
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.