Microbiologists carry out a lot of environmental montoring, but is this sufficiently focused? Are too many samples taken? Are samples taken in the wrong locations or at the wrong frequency? Some ideas are presented.

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