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Environmental Monitoring
Justifying less monitoring,
sampling and testing
Facilitator: Tim Sandle
Doing less what?
• Less:
– Sampling
– Monitoring
– Testing
Why should we consider doing
less?
• To save time
• To save money (media costs, reporting etc)
• Due to lack of skilled staff
• To deploy resources elsewhere
• Because the data doesn’t tell us anything
• Because we may have time to gather data but
not to review it
• Because the trends have been satisfactory for a
long period
• Because risk assessments indicate a low or
negligible risk
How can we do less?
• Matrix approaches for validation
and test regimes
• Do we need pre-, during and post-
batch micro data?
• Reviewing historical data
– Review of investigation and
testing results
• Linking data to specific events
• Risk assessment:
– What does past data tell us?
– Does it matter what is going on or
what type of processing more than
the grade of the room or the
utility?
• Linking data together for the big
picture & considering physical
data
• Rationale
What are the obstacles
• Internal company procedures
• Regulatory expectations
– FDA is less prescriptive and only state that
monitoring, such as EM, be frequent
• Keen staff
• Custom and practice
• Uncertainty
What is the point of testing?
• Batch release tests e.g. raw materials
• Equipment verification, e.g. six-monthly
autoclave tests
• Hygiene monitoring of intermediate stage
codes, where the data relates to the batch
and can be trended for other batches
• Water and environmental monitoring: long-
term trends over time
Examples of application
• Raw materials
– Frequency of raw materials testing
– Sample size for raw materials
– Number of containers to be examined
– Performing TAMC/TYMC and selective micro-
organism testing each time?
Examples of application
• Culture media
– Reduced testing
– Testing environmental isolates at the same
frequency as typed cultures?
– Testing each lot, batch or delivery?
Examples of application
• Microbial identifications
– Every sample with growth?
– Every sample exceeding the action level?
– A proportion of samples from lower grade
cleanrooms?
– Level:
• Gram-stain
• Species
• Phenotypic
• Genotypic
Examples of application
• Environmental monitoring
– Frequency of monitoring
• Sterile area (Grade B support areas)
• Grade C and D areas
• Controlled but not classified areas
• More monitoring under special circumstances e.g. media trials,
start-up after shutdowns?
– Number of sample locations
• Rotating locations?
• Dynamic sampling plans?
– Time of monitoring (24/7 processing)
– General bioburden versus selective monitoring (fungal,
anaerobic etc)
– What happens after maintenance work?
Examples of application
• Steam sterilisation
– How often should biological indicators be
used?
– How many locations are typical?
• Depyrogenation studies
– How often should endotoxin indicators be
used?
– How many locations are typical?
Examples of application
• In-process samples
– How many samples are representative of a
typical manufacturing process?
– For aseptic filling, is it only the pre-final
filtration sample which matters?
Examples of application
• Water sampling
– Frequency of monitoring
– Differences for WFI and purified water
– Do all outlets need to be taken at the same
frequency?
– Are water generation (plant) samples taken
more often?
Other considerations
• How many repeat samples should be
taken?
– 3?
– Is there any advantage in taking repeats until
the root cause has been addressed?
– What is a repeat?
5 -10 points required for
conference feedback
Thank you

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Reviewing environmental monitoring.ppt

  • 1. Environmental Monitoring Justifying less monitoring, sampling and testing Facilitator: Tim Sandle
  • 2. Doing less what? • Less: – Sampling – Monitoring – Testing
  • 3. Why should we consider doing less? • To save time • To save money (media costs, reporting etc) • Due to lack of skilled staff • To deploy resources elsewhere • Because the data doesn’t tell us anything • Because we may have time to gather data but not to review it • Because the trends have been satisfactory for a long period • Because risk assessments indicate a low or negligible risk
  • 4. How can we do less? • Matrix approaches for validation and test regimes • Do we need pre-, during and post- batch micro data? • Reviewing historical data – Review of investigation and testing results • Linking data to specific events • Risk assessment: – What does past data tell us? – Does it matter what is going on or what type of processing more than the grade of the room or the utility? • Linking data together for the big picture & considering physical data • Rationale
  • 5. What are the obstacles • Internal company procedures • Regulatory expectations – FDA is less prescriptive and only state that monitoring, such as EM, be frequent • Keen staff • Custom and practice • Uncertainty
  • 6. What is the point of testing? • Batch release tests e.g. raw materials • Equipment verification, e.g. six-monthly autoclave tests • Hygiene monitoring of intermediate stage codes, where the data relates to the batch and can be trended for other batches • Water and environmental monitoring: long- term trends over time
  • 7. Examples of application • Raw materials – Frequency of raw materials testing – Sample size for raw materials – Number of containers to be examined – Performing TAMC/TYMC and selective micro- organism testing each time?
  • 8. Examples of application • Culture media – Reduced testing – Testing environmental isolates at the same frequency as typed cultures? – Testing each lot, batch or delivery?
  • 9. Examples of application • Microbial identifications – Every sample with growth? – Every sample exceeding the action level? – A proportion of samples from lower grade cleanrooms? – Level: • Gram-stain • Species • Phenotypic • Genotypic
  • 10. Examples of application • Environmental monitoring – Frequency of monitoring • Sterile area (Grade B support areas) • Grade C and D areas • Controlled but not classified areas • More monitoring under special circumstances e.g. media trials, start-up after shutdowns? – Number of sample locations • Rotating locations? • Dynamic sampling plans? – Time of monitoring (24/7 processing) – General bioburden versus selective monitoring (fungal, anaerobic etc) – What happens after maintenance work?
  • 11. Examples of application • Steam sterilisation – How often should biological indicators be used? – How many locations are typical? • Depyrogenation studies – How often should endotoxin indicators be used? – How many locations are typical?
  • 12. Examples of application • In-process samples – How many samples are representative of a typical manufacturing process? – For aseptic filling, is it only the pre-final filtration sample which matters?
  • 13. Examples of application • Water sampling – Frequency of monitoring – Differences for WFI and purified water – Do all outlets need to be taken at the same frequency? – Are water generation (plant) samples taken more often?
  • 14. Other considerations • How many repeat samples should be taken? – 3? – Is there any advantage in taking repeats until the root cause has been addressed? – What is a repeat?
  • 15. 5 -10 points required for conference feedback Thank you