Formulation of Advanced or Complex Medicines 9 Flashcards
What are the advantages of filtration sterilisation?
Low cost and rapid disinfection/sterilisation
Use for heat labile material
Can be used to remove chemical contaminants also
Impregnated with biocide combining capture and kill
What are the disadvantages of filtration sterilisation?
Not a microbicidal process
- does not kill bacteria
Shedding of filter components
Fluid retention
- principally depth filters
May become blocked easily
What parameters can be used to predict the lethality of the sterilisation process?
Inactivation kinetic
Predict changes in temperature on the overall lethality
Validate alternative regimens
- different products
What factors can be used to calculate lethality of the sterilisation process?
D value
Z value
Inactivation factor
Most probable effective dose
What is the D value?
The time taken at a fixed temperature (or radiation dose) required to achieve a 90% reduction in viable cells
Why is sterilisation validation important
The achievement of sterility for any one item in a population of items submitted to a sterilisation process can neither be guaranteed nor demonstrated. It is essential to study the effect of the chosen sterilisation procedure on the product (including its final container) to ensure its effectiveness and the integrity of the product, and to validate the procedure before it is applied in practice. Failure to follow meticulously a validated process introduces frisk of a non-sterile and/or deteriorated product
What is sterilisation validation?
Documented procedure for obtaining, recording and interpreting data required to show that a process will consistently comply with pre-determined specifications
What are the two types of data needed for sterilisation validation?
Commissioning data
Performance qualification data
What is commissioning data?
Evidence that process equipment has been installed in accordance with specifications
Equipment is safe to use
Functions within pre-determined limits
What is performance qualification data?
Evidence that equipment will produce a product with an acceptable assurance of sterility
What are the two types of evidence used in performance qualification data?
Physical
Biological
When must performance qualification data be re-evaluated?
If any changes are made to the product, its packaging, its loading pattern or the sterilisation cycle
Who releases details on sterilising validation?
International governing bodies
- International Standard Organisation (ISO)
What physical indicators are used to generate performance qualification data?
Measurement of
- heat distribution (thermocouple)
- pressure variation (gauges or transducers)
- relative humidity (hygrometers or direct calorimetry)
Sensors must be maintained and calibrated regularly
What types of chemical indicators are used to generate performance qualification data?
Process
Single variable
- temp tubes
Multi-variable
- Browne’s tubes
Integrating
- dosimeters
Specific
