Introduction Flashcards
What are micro organisms used for ?
As cell factories to make medicines
What is microbiology used for ?
Used in lab testing to check medicines
Factors to be considered when designing a microbial QC programme
Sample to be analysed
Choice of tests
Frequency of testing
Methods for their validation
Samples to be analysed
Raw materials , in line samples , end products , water , air , surfaces , personnel
Types of general counts
Total viable counts
Total anaerobes
Spores
Total viable counts
Also known as standard plate count
Example of test method
European Pharmacopoeia
Total cell count
Living and dead cell enumeration
Indicator organism
Used for analysis for faecal contamination
Total coliforms
35-37 degrees for 48 hours
Indicators of general level of sanitation
Selective media for coliforms
MacConkey Agar
Violet Bile Agar
Examples of Micro organism contamination of medicinal products
Eye care products
Powders
Water
Mouthwashes
Main sources of microbial contamination
Raw materials
Water
Personnel
Packaging components
Air
Post processing contamination
In use contamination
Stages of microbial growth curve
Lag phase
Log phase
Stationary phase
Death phase
Lag phase
Period of no growth / slow growth
Log phase
Cell division begins
Number of cells increases exponentially
Stationary phase
No overall growth due to nutrient depletion / lack of space
Death phase
Cell death spores can survive
Viable cell counts
Living cells only
Viable cell counts
Pour Plate technique
Spread Plate technique
Membrane filtration method
Dip slides
Millipore samples
Sim Plates
Colliert kits
Colony forming units
C.f.u
Diluents used
Ringers Solution
Pour plate method
Most suitable when small numbers of bacteria are expected.
48-50 degrees
Pour plate technique
Day 1: Serial dilution and set up samples in agar
Day 2: count plates
Spread Plate technique
30-35 degrees for 72 hours
Reading results
For all TVC all types of colonies are counted
Only use 25-250
C.f.u ml / g
Validation and controls
Negative controls on sterility of medium used .
Growth promotion test as validation test .
Colilert
Uses DST
DST
Defined substrate technology
Applications of Colilert
Analysis of water for faecal indicators
DST is
A method of isolating and identifying bacteria through the effect of the enzymes on chromogenically labelled specific substrates
