(4) Sterile Products 1+2 Flashcards
(20 cards)
outline the 4 grades of manufacture of sterile medicinal products.
grade a = the local zone for high risk operations. These conditions are provided by laminar air flow: providing a homogeneous air speed of 0.45m/s +- 20% at the working station.
grade b = this provides the background environment for grade A zone items needing aseptic preparation and filling
grade c/d = areas graded C and D are used for performing less critical tasks that are carried out during less critical stages in the manufacturing process.
outline the overkill method (sterilisation process)
(most popular)
- start with an unrealistic bioburden, find out a D value form this (usually spores of thermophile)
- then complete for a total of 12 D values, which will kill all ‘normal bacteria”
outline the sterility assurance level? (Sterilization process)
- sterility is an absolute concept (either sterile or not)
- it is The likelihood of a product being sterile (free from microorganisms) can be expressed in terms of the probability of a microorganism surviving the treatment process.
- this gives rise to the concept of Sterility Assurance Level (SAL)
what 2 factors influence the time taken to sterilise a product?
- (N0) initial level of contamination (the bioburden)
- k - the rate of kill, which is dependent on the temperature and the thermal resistance of the organism
what are the 3 stages of process validation?
• Stage 1 – Process Design: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
What are the 3 stages of process validation?
- Stage 1 –PROCESS DESIGN: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.
- Stage 2 – PRCESS QUALIFICATION: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.
- Stage 3 –CONTINUED PROCESS VERIFICATION: Ongoing assurance is gained during routine production that the process remains in a state of control.
What are the 3 things important in good manufacturing practice?
- personell
- process
- environment
what do you need to consider when choosing a sterilisation process?
- knowledge of the lethality of the chosen sterilization process (D value)
what does validation of a sterilisation process require knowledge of?
• Lethality of the process
• Effects of changing sterilization conditions
what is a phase transition?
when a gas at its phase boundary temperature interacts with a colder object, it undergoes phase transition (think of a kettle gaseous water hits cold air around it and recondneses = steam)
what is latent heat (energy)?
this is hidden heat - we don’t see a temperature increase despite adding heat (eg water @100C - can keep using a bunsen burner but temp won’t rise)
what is parametric release?
Parametric release is a system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process.
- based on evidence of successful validation of the manufacturing process
what is process validation?
process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Process validation is a requirement of current Good Manufacturing Practices
what is sensible heat (energy)
is the amount of heat that, when added or removed from a substance, causes a change in its temperature but does not cause a phase change (eg raising water from 40C to 60C)
what is the D value?
time (mins) taken to reduce the population size by 90%
what is the Sterility Assurance Level (SAL)?
the degree of assurance with which the process in question
renders the population of items sterile
what is the Z value?
increase in temperature required to reduce the D value for an organism by 90% reduction
what is thermal death time?
time required to kill a population of the target microorganism at a given temperature
what products can parametric release only be applied to?
Parametric release can only be applied to products terminally sterilised in their final containers
What’s the definition of F value and what is it used for?
- F is defined as the equivalent time at temperature (T) is delivered to a container or unit of product for the purpose of sterilization.
- Permits comparison of lethal effects of heating at any temperature to prescribed conditions (121oC)
